The Experts below are selected from a list of 6045 Experts worldwide ranked by ideXlab platform
Kyle M. Kampman - One of the best experts on this subject based on the ideXlab platform.
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a double blind placebo controlled trial of modafinil for the treatment of Cocaine Dependence without co morbid alcohol Dependence
Drug and Alcohol Dependence, 2015Co-Authors: Kyle M. Kampman, Kevin G Lynch, Charles A. Dackis, Helen M. Pettinati, Kelly Anne Spratt, Michael R Wierzbicki, Charles P ObrienAbstract:Background Modafinil is a medication approved for narcolepsy and shift work sleep disorder. It has both dopaminergic and glutamatergic activity that could be useful for the treatment of Cocaine Dependence. Modafinil has reduced Cocaine subjective effects and Cocaine self-administration in human laboratory trials and has reduced Cocaine use in Cocaine dependent patients in some clinical trials.
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multisite randomized double blind placebo controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse prevention treatment for Cocaine Dependence
The Journal of Clinical Psychiatry, 2014Co-Authors: Theresa Winhusen, Kyle M. Kampman, Frankie Kropp, Robert Lindblad, Antoine Douaihy, Louise Haynes, Candace C Hodgkins, Karen Chartier, Gaurav Sharma, Daniel LewisAbstract:OBJECTIVE To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for Cocaine Dependence. METHOD A randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack Cocaine users meeting DSM-IV-TR criteria for current Cocaine Dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d (n = 35) or placebo (n = 27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous Cocaine abstinence (primary), proportion of Cocaine use days, and days to first Cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens. RESULTS There were no significant treatment effects on maximum continuous days of Cocaine abstinence or days to first Cocaine use. In the female participants (n = 23), there was a significant treatment-by-time interaction effect (χ²₁ = 15.26, P < .0001), reflecting an increase in Cocaine use by those receiving buspirone, relative to placebo, early in the outpatient treatment phase. A similar effect was not detected in the male participants (n = 39; χ²₁ = 0.14, P = .70). CONCLUSIONS The results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to Cocaine use and that buspirone for Cocaine-dependent women may worsen their Cocaine use outcomes. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01641159.
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a double blind placebo controlled trial of modafinil for Cocaine Dependence
Journal of Substance Abuse Treatment, 2012Co-Authors: Charles A. Dackis, Thorne Sparkman, Kevin G Lynch, Kyle M. Kampman, Helen M. Pettinati, Jennifer G Plebani, Charles P ObrienAbstract:Abstract This is a randomized, double-blind, placebo-controlled study of modafinil treatment for Cocaine Dependence. Patients ( N = 210) who were actively using Cocaine at baseline were randomized to 8 weeks of modafinil (0 mg/day, 200 mg/day, or 400 mg/day) combined with once-weekly cognitive–behavioral therapy. Our primary efficacy measure was Cocaine abstinence, based on urine benzoylecgonine (BE) levels, with secondary measures of craving, Cocaine withdrawal, retention, and tolerability. We found no significant differences between modafinil and placebo patients on any of these measures. However, there was a significant gender difference in that male patients treated with 400 mg/day tended to be more abstinent than their placebo-treated counterparts ( p = .06). Our negative findings might be explained by gender differences and/or inadequate psychosocial treatment intensity in patients with severe Cocaine Dependence.
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A double-blind, placebo-controlled pilot trial of acamprosate for the treatment of Cocaine Dependence.
Addictive Behaviors, 2010Co-Authors: Kyle M. Kampman, Thorne Sparkman, Kevin G Lynch, Charles A. Dackis, Helen M. Pettinati, Charles P. O'brienAbstract:Abstract Background Acamprosate is a medication shown to be effective for the treatment of alcohol Dependence. Although the exact mechanism of action of acamprosate is unknown, evidence suggests that it decreases excitatory amino acid activity by post-synaptic inhibition of the NMDA subtype of glutamate receptors. It is possible that the activity of acamprosate via modulating glutamatergic activity could also reduce craving for Cocaine and impact abstinence in Cocaine Dependence. Therefore, we conducted a double-blind placebo-controlled pilot trial of acamprosate for the treatment of Cocaine Dependence. Methods Sixty male and female Cocaine dependent patients were included in a nine week double-blind, placebo-controlled trial. After a one-week baseline, patients were randomized to receive acamprosate 666 mg three times daily or identical placebo tablets for eight weeks. The primary outcome measure was Cocaine use as determined by twice weekly urine drug screens. Results Thirty-six patients (60%) completed the trial, with no significant between-group difference in treatment retention. Percent Cocaine positive urine drug screens did not differ between the two groups. Acamprosate was no better than placebo in reducing Cocaine craving, reducing Cocaine withdrawal symptoms, or improving measures of drug use severity from the Addiction Severity Index. Adverse events in this trial were generally mild and were evenly distributed between the two groups. Discussion Acamprosate was well tolerated but was no more efficacious than placebo in promoting abstinence from Cocaine in Cocaine dependent patients. Acamprosate does not appear to be a promising medication for the treatment of Cocaine Dependence.
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genetic variants in the Cocaine and amphetamine regulated transcript gene cartpt and Cocaine Dependence
Neuroscience Letters, 2008Co-Authors: Falk W Lohoff, Kyle M. Kampman, Helen M. Pettinati, Paul J Bloch, Andrew E Weller, Aleksandra H Nall, Glenn A Doyle, Russell J Buono, Thomas N Ferraro, Charles A. DackisAbstract:Dopaminergic brain systems have been implicated to play a major role in drug reward, thus making genes involved in these circuits plausible candidates for susceptibility to substance use disorders. The Cocaine- and amphetamine-regulated transcript peptide (CARTPT) is involved in reward and feeding behavior and has functional characteristics of an endogenous psychostimulant. In this study we tested the hypothesis that variation in the CARTPT gene increases susceptibility to Cocaine Dependence in individuals of African descent. Genotypes of three HapMap tagging SNPs (rs6894758; rs11575893; rs17358300) across the CARTPT gene region were obtained in Cocaine dependent individuals (n=348) and normal controls (n=256). All subjects were of African descent. There were no significant differences in allele, genotype or haplotype frequencies between cases and controls for any of the tested SNPs. Our results do not support an association of the CARTPT gene with Cocaine Dependence; however, additional studies using larger samples, comprehensive SNP coverage, and different populations are necessary to conclusively rule out CARTPT as a contributing factor in the etiology of Cocaine Dependence.
Charles P Obrien - One of the best experts on this subject based on the ideXlab platform.
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a double blind placebo controlled trial of modafinil for the treatment of Cocaine Dependence without co morbid alcohol Dependence
Drug and Alcohol Dependence, 2015Co-Authors: Kyle M. Kampman, Kevin G Lynch, Charles A. Dackis, Helen M. Pettinati, Kelly Anne Spratt, Michael R Wierzbicki, Charles P ObrienAbstract:Background Modafinil is a medication approved for narcolepsy and shift work sleep disorder. It has both dopaminergic and glutamatergic activity that could be useful for the treatment of Cocaine Dependence. Modafinil has reduced Cocaine subjective effects and Cocaine self-administration in human laboratory trials and has reduced Cocaine use in Cocaine dependent patients in some clinical trials.
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a double blind placebo controlled trial of modafinil for Cocaine Dependence
Journal of Substance Abuse Treatment, 2012Co-Authors: Charles A. Dackis, Thorne Sparkman, Kevin G Lynch, Kyle M. Kampman, Helen M. Pettinati, Jennifer G Plebani, Charles P ObrienAbstract:Abstract This is a randomized, double-blind, placebo-controlled study of modafinil treatment for Cocaine Dependence. Patients ( N = 210) who were actively using Cocaine at baseline were randomized to 8 weeks of modafinil (0 mg/day, 200 mg/day, or 400 mg/day) combined with once-weekly cognitive–behavioral therapy. Our primary efficacy measure was Cocaine abstinence, based on urine benzoylecgonine (BE) levels, with secondary measures of craving, Cocaine withdrawal, retention, and tolerability. We found no significant differences between modafinil and placebo patients on any of these measures. However, there was a significant gender difference in that male patients treated with 400 mg/day tended to be more abstinent than their placebo-treated counterparts ( p = .06). Our negative findings might be explained by gender differences and/or inadequate psychosocial treatment intensity in patients with severe Cocaine Dependence.
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a pilot trial of topiramate for the treatment of Cocaine Dependence
Drug and Alcohol Dependence, 2004Co-Authors: Thorne Sparkman, Kevin G Lynch, Kyle M. Kampman, Charles A. Dackis, Helen M. Pettinati, Catherine Weigley, Charles P ObrienAbstract:Background: Both GABAergic and glutamatergic neurons appear to be important modulators of the brain reward system and medications that affect GABA and glutamatergic neurotransmission may reduce the rewarding properties of Cocaine and reduce Cocaine craving. Topiramate, an anticonvulsant, raises cerebral GABA levels, facilitates GABAergic neurotransmission and inhibits glutametergic activity at AMPA/kainite receptors. Thus, it may be useful for treating Cocaine Dependence. Methods: The efficacy of topiramate for Cocaine Dependence was tested in a 13-week, double-blind, placebo-controlled pilot trial ( n = 40). Topiramate was titrated gradually over 8 weeks to a dose of 200 mg daily. The primary outcome measure was Cocaine abstinence verified by twice weekly urine benzoylecgonine tests (UBT). Results: Eighty-two percent of subjects completed the trial. Analysis of the UBT using a GEE model showed that after week 8, when the dose titration was completed, topiramate-treated subjects were more likely to be abstinent from Cocaine compared to placebo-treated subjects ( Z = 2.67, P = 0.01). Topiramate-treated subjects were also more likely to attain 3 weeks of continuous abstinence from Cocaine (χ 2 = 3.9, d.f. = 1, P = 0.05). Conclusion: Topiramate may be effective for the treatment of Cocaine Dependence.
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Cocaine Dependence severity predicts outcome in outpatient detoxification from Cocaine and alcohol
American Journal on Addictions, 2004Co-Authors: Helen M. Pettinati, Charles P Obrien, M Kyle M D Kampman, Joseph R Volpicelli, M David M D Oslin, B Craig S Lipkin, M Thorne D SparkmanAbstract:This study compared the effects of alcohol and Cocaine Dependence severity on the outcome of outpatient detoxification from alcohol and Cocaine. Subjects included 84 subjects with both alcohol and Cocaine Dependence admitted for outpatient detoxification. Fifty-three of the 84 subjects (63%) completed detoxification. Baseline Cocaine use, Cocaine craving, and Cocaine withdrawal symptoms predicted detoxification outcome, whereas alcohol use, alcohol craving, and alcohol withdrawal symptoms did not. Among Cocaine- and alcohol-dependent subjects, Cocaine Dependence severity appears to be a more important predictor of detoxification success than alcohol Dependence severity.
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a pilot trial of piracetam and ginkgo biloba for the treatment of Cocaine Dependence
Addictive Behaviors, 2003Co-Authors: Kyle M. Kampman, Charles A. Dackis, Maria Dorota Majewska, Karen Tourian, James W Cornish, Sabrina Poole, Charles P ObrienAbstract:Background: Chronic Cocaine use is associated with cognitive deficits that may reduce the effectiveness of psychosocial treatment and promote relapse in newly abstinent Cocaine-dependent patients. Nootropic agents, such as piracetam and ginkgo biloba, may improve cognitive function and reduce the incidence of relapse in these patients. Methods: This was a 10-week, double-blind, placebo-controlled pilot trial involving 44 Cocaine-dependent subjects. Subjects received either piracetam (4.8 g/day), ginkgo biloba (120 mg/day), or placebo. Subjects were required to attain abstinence from Cocaine during a 2-week baseline phase demonstrated by providing at least one benzoylecgonine (BE)-negative urine toxicology screen. Outcome measures included treatment retention, urine toxicology screens, Clinical Global Impression (CGI) scores, and results from the Addiction Severity Index (ASI). Results: Ginkgo biloba was not superior to placebo in any outcome measure. Piracetam was associated with more Cocaine use and lower CGI scores compared to placebo. Conclusions: Neither piracetam nor ginkgo biloba appears to be a promising medication for the treatment of Cocaine Dependence.
Theresa Winhusen - One of the best experts on this subject based on the ideXlab platform.
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multisite randomized double blind placebo controlled pilot clinical trial to evaluate the efficacy of buspirone as a relapse prevention treatment for Cocaine Dependence
The Journal of Clinical Psychiatry, 2014Co-Authors: Theresa Winhusen, Kyle M. Kampman, Frankie Kropp, Robert Lindblad, Antoine Douaihy, Louise Haynes, Candace C Hodgkins, Karen Chartier, Gaurav Sharma, Daniel LewisAbstract:OBJECTIVE To evaluate the potential efficacy of buspirone as a relapse-prevention treatment for Cocaine Dependence. METHOD A randomized, double-blind, placebo-controlled, 16-week pilot trial was conducted at 6 clinical sites between August 2012 and June 2013. Adult crack Cocaine users meeting DSM-IV-TR criteria for current Cocaine Dependence who were scheduled to be in inpatient/residential substance use disorder (SUD) treatment for 12-19 days when randomized and planning to enroll in local outpatient treatment through the end of the active treatment phase were randomized to buspirone titrated to 60 mg/d (n = 35) or placebo (n = 27). All participants received psychosocial treatment as usually provided by the SUD treatment programs in which they were enrolled. Outcome measures included maximum days of continuous Cocaine abstinence (primary), proportion of Cocaine use days, and days to first Cocaine use during the outpatient treatment phase (study weeks 4-15) as assessed by self-report and urine drug screens. RESULTS There were no significant treatment effects on maximum continuous days of Cocaine abstinence or days to first Cocaine use. In the female participants (n = 23), there was a significant treatment-by-time interaction effect (χ²₁ = 15.26, P < .0001), reflecting an increase in Cocaine use by those receiving buspirone, relative to placebo, early in the outpatient treatment phase. A similar effect was not detected in the male participants (n = 39; χ²₁ = 0.14, P = .70). CONCLUSIONS The results suggest that buspirone is unlikely to have a beneficial effect on preventing relapse to Cocaine use and that buspirone for Cocaine-dependent women may worsen their Cocaine use outcomes. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01641159.
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evaluation of buspirone for relapse prevention in adults with Cocaine Dependence an efficacy trial conducted in the real world
Contemporary Clinical Trials, 2012Co-Authors: Theresa Winhusen, Maxine L Stitzer, George E Woody, Kathleen T Brady, Frankie Kropp, Robert Lindblad, Gregory S Brigham, David R Liu, Steven Sparenborg, Gaurav SharmaAbstract:Abstract Cocaine Dependence is a significant public health problem for which there are currently no FDA-approved medications. Hence, identifying candidate compounds and employing an efficient evaluation process is crucial. This paper describes key design decisions made for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) study that uses a novel two-stage process to evaluate buspirone (60 mg/day) for Cocaine-relapse prevention. The study includes pilot (N = 60) and full-scale (estimated N = 264) trials. Both trials will be randomized, double-blind, and placebo-controlled and both will enroll treatment-seeking Cocaine-dependent participants engaged in inpatient/residential treatment and scheduled for outpatient treatment post-discharge. All participants will receive contingency management in which incentives are given for medication adherence as evaluated by the Medication Events Monitoring System (MEMS). The primary outcome measure is maximum days of continuous Cocaine abstinence, as assessed by twice-weekly urine drug screens (UDS) and self-report, during the 15-week outpatient treatment phase. Drug-abuse outcomes include Cocaine use as assessed by UDS and self-report of Cocaine use, other substance use as assessed by UDS and self-report of substance use (i.e., alcohol and/or illicit drugs), Cocaine bingeing, HIV risk behavior, quality of life, functioning, and substance abuse treatment attendance. Unique aspects of the study include conducting an efficacy trial in community treatment programs, a two-stage process to efficiently evaluate buspirone, and an evaluation of mediators by which buspirone might exert a beneficial effect on relapse prevention.
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the srphk1 outcome measure for Cocaine Dependence trials combines self report urine benzoylecgonine levels and the concordance between the two to determine a Cocaine use status for each study day
Drug and Alcohol Dependence, 2008Co-Authors: Frank Vocci, Eugene Somoza, Daniel Lewis, Theresa Winhusen, Peggy Somoza, Nora Chiang, Paul S Horn, Ahmed ElkashefAbstract:Abstract Background There is currently no FDA-approved medication for Cocaine Dependence and no standard primary outcome measure for reduction of Cocaine use in Cocaine-Dependence trials. The ability to detect a significant medication effect will depend, in part, on the primary outcome measure utilized. The goal of the present paper is to compare self-report or either of two urine toxicology measures used alone to a relatively new measure – the SRPHK1 – which combines self-report, quantitative urine benzoylecgonine levels, and an estimate of the concordance between the two to determine the Cocaine-use status of each study day. Method Datasets from two separate randomized, placebo-controlled Cocaine-Dependence trials were used to compare four Cocaine-use outcome measures. Results The two data sets yielded very similar findings and suggest that the combined measure is associated with significantly fewer missing data than urine toxicology and that estimated Cocaine use varied significantly depending on which measure was used, with the lowest use estimate being yielded by self-report, the highest by the two urine toxicology measures evaluated, and an intermediate value obtained using the combined measure. The results also suggest that the concordance between self-report and urine toxicology is around 90% at the beginning of the clinical trial but decreases to around 75% by the end of the trial. Conclusion By combining the objectivity of urine toxicology with the reduced incidence of missing data characteristic of self-report, the SRPHK1 may provide advantages over self-report or urine toxicology measures used alone. In any case, the SRPHK1 provides an interesting complement to these other outcome measures and may warrant further evaluation.
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a double blind placebo controlled trial of tiagabine for the treatment of Cocaine Dependence
Drug and Alcohol Dependence, 2007Co-Authors: Theresa Winhusen, Eugene Somoza, Domenic A Ciraulo, John Grabowski, Judy M Harrer, Jeffrey R Goldsmith, Florence S ColemanAbstract:Abstract Background The potential efficacy of tiagabine for treating Cocaine Dependence is suggested by both pre-clinical research and two small clinical trials. Method One hundred and forty one participants who met DSM-IV criteria for Cocaine Dependence were enrolled into this 12-week, double blind, placebo controlled outpatient trial. Participants received either tiagabine (20 mg/day) or matching placebo. All participants received 1 h of manualized individual cognitive behavioral therapy on a weekly basis. Outcome measures included Cocaine use as determined by self-report confirmed with urine benzoylecgonine (BE) results, and qualitative and quantitative urine toxicology measures. Safety measures included adverse events, EKGs, vital signs, and laboratory tests. Results Seventy-nine participants (i.e., 56%) completed the 12-week trial. The safety results suggest that tiagabine was safe and generally well tolerated by the participants. Participants in both groups improved significantly on Cocaine craving and global functioning, with no significant differences between the groups. There were no significant changes in Cocaine use as measured by self-report confirmed by urine BE or by quantitative urine toxicology results. Qualitative urine toxicology results suggest a possible weak effect for tiagabine in reducing Cocaine use. Conclusion These results suggest that tiagabine, at a dose of 20 mg/day, did not have a robust effect in decreasing Cocaine use.
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a double blind placebo controlled trial of reserpine for the treatment of Cocaine Dependence
Drug and Alcohol Dependence, 2007Co-Authors: Theresa Winhusen, Eugene Somoza, Judy M Harrer, Jeffrey R Goldsmith, Florence S Coleman, Juris P Mezinskis, Ofra Saridsegal, Roberta Kahn, Sabuhi Osman, Daniel LewisAbstract:Abstract Background Cocaine's increase of dopamine is strongly associated with its reinforcing properties and, thus, agents that reduce dopamine have received much attention as candidate Cocaine-Dependence treatments. The potential efficacy of reserpine, a dopamine depletor, for treating Cocaine Dependence is suggested by both pre-clinical research and a small clinical trial. Method One hundred and nineteen participants who met DSM-IV criteria for Cocaine Dependence were enrolled into this 12-week, double-blind, placebo-controlled outpatient trial. Participants received either reserpine (0.5 mg/day) or matching placebo. All participants received 1 h of manualized individual cognitive behavioral therapy on a weekly basis. Outcome measures included Cocaine use as determined by self-report confirmed with urine benzoylecgonine results, Cocaine craving, addiction severity index scores, and clinical global impression scores. Safety measures included adverse events, EKGs, vital signs, laboratory tests, and the Hamilton Depression Inventory. Results Seventy-nine participants (i.e., 66%) completed the 12-week trial. The safety results suggest that reserpine was safe and well tolerated by the participants. The efficacy measures indicated no significant differences between reserpine and placebo. Conclusion These results do not support the efficacy of reserpine as a Cocaine-Dependence treatment.
Thomas R Kosten - One of the best experts on this subject based on the ideXlab platform.
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randomized clinical trial of disulfiram for Cocaine Dependence or abuse during buprenorphine treatment
Drug and Alcohol Dependence, 2014Co-Authors: Richard S Schottenfeld, Joseph F. Cubells, Marek C Chawarski, Tony P George, Jaakko Lappalainen, Thomas R KostenAbstract:Abstract Background Disulfiram may be efficacious for treating Cocaine Dependence or abuse, possibly through inhibiting dopamine β-hydroxylase (DβH). Consequently, this randomized, placebo-controlled clinical trial of disulfiram during buprenorphine maintenance treatment evaluated the study hypothesis that disulfiram is superior to placebo and explored whether disulfiram response is greatest for participants with a single nucleotide polymorphism coding for genetically low DβH (T-allele carriers). Methods We randomized 177 buprenorphine-treated opioid dependent participants with Cocaine Dependence or abuse to 12 weeks of double-blind treatment with disulfiram 250 mg daily ( n = 91) or placebo ( n = 86). Of 155 participants genotyped, 84 were CC-homozygous, and 71 CT or TT genotypes. Primary outcomes included days per week Cocaine use, number of Cocaine-negative urine tests, and maximum consecutive weeks of Cocaine abstinence. We analyzed an intention-to-treat comparison between disulfiram and placebo. We also explored potential pharmacogenetic interactions and examined treatment responses of four participant groups based on medication (disulfiram or placebo) by genotype (CC-homozygous or T-allele carrier) classification. Results Disulfiram participants reported significantly less frequent Cocaine use; the differences in Cocaine-negative urine tests or consecutive weeks abstinence were not significant. Frequency of Cocaine use was lowest in disulfiram-treated T-allele carriers; differences in Cocaine-negative urine tests or consecutive weeks abstinence were not significant among the four medication-genotype groups. Conclusions The findings provide limited support for the efficacy of disulfiram for reducing Cocaine use and suggest that its mechanism of action may involve inhibition of DβH. Further studies of its efficacy, mechanism of action, and pharmacogenetics of response are warranted.
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Cocaine vaccine for the treatment of Cocaine Dependence in methadone maintained patients a randomized double blind placebo controlled efficacy trial
Archives of General Psychiatry, 2009Co-Authors: Bridget Martell, Frank M Orson, James Poling, Ellen S Mitchell, Roger D Rossen, Tracie J Gardner, Thomas R KostenAbstract:Context Cocaine Dependence, which affects 2.5 million Americans annually, has no US Food and Drug Administration–approved pharmacotherapy. Objectives To evaluate the immunogenicity, safety, and efficacy of a novel Cocaine vaccine to treat Cocaine Dependence. Design A 24-week, phase 2b, randomized, double-blind, placebo-controlled trial with efficacy assessed during weeks 8 to 20 and follow-up to week 24. Setting Cocaine- and opioid-dependent persons recruited from October 2003 to April 2005 from greater New Haven, Connecticut. Participants One hundred fifteen methadone-maintained subjects (67% male, 87% white, aged 18-46 years) were randomized to vaccine or placebo, and 94 subjects (82%) completed the trial. Most smoked crack Cocaine along with using marijuana (18%), alcohol (10%), and nonprescription opioids (44%). Intervention Over 12 weeks, 109 of 115 subjects received 5 vaccinations of placebo or succinylnorCocaine linked to recombinant cholera toxin B-subunit protein. Main Outcome Measure Semiquantitative urinary Cocaine metabolite levels measured thrice weekly with a positive cutoff of 300 ng/mL. Results The 21 vaccinated subjects (38%) who attained serum IgG antiCocaine antibody levels of 43 μg/mL or higher (ie, high IgG level) had significantly more Cocaine-free urine samples than those with levels less than 43 μg/mL (ie, low IgG level) and the placebo-receiving subjects during weeks 9 to 16 (45% vs 35% Cocaine-free urine samples, respectively). The proportion of subjects having a 50% reduction in Cocaine use was significantly greater in the subjects with a high IgG level than in subjects with a low IgG level (53% of subjects vs 23% of subjects, respectively) ( P = .048). The most common adverse effects were injection site induration and tenderness. There were no treatment-related serious adverse events, withdrawals, or deaths. Conclusions Attaining high (≥43 μg/mL) IgG antiCocaine antibody levels was associated with significantly reduced Cocaine use, but only 38% of the vaccinated subjects attained these IgG levels and they had only 2 months of adequate Cocaine blockade. Thus, we need improved vaccines and boosters. Trial Registration clinicaltrials.gov Identifier:NCT00142857
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six month trial of bupropion with contingency management for Cocaine Dependence in a methadone maintained population
Archives of General Psychiatry, 2006Co-Authors: James Poling, Bridget Martell, Alison Oliveto, Nancy M Petry, Mehmet Sofuoglu, Kishorchandra Gonsai, Gerardo Gonzalez, Thomas R KostenAbstract:Context No effective pharmacotherapies exist for Cocaine Dependence, although contingency management (CM) has demonstrated efficacy. Objective To compare the efficacy of bupropion hydrochloride and CM for reducing Cocaine use in methadone hydrochloride–maintained individuals. Design This 25-week, placebo-controlled, double-blind trial randomly assigned participants to 1 of 4 treatment conditions: CM and placebo (CMP), CM and 300 mg/d of bupropion hydrochloride (CMB), voucher control and placebo (VCP), or voucher control and bupropion (VCB). Setting Outpatient clinic at the Veterans Affairs Connecticut Healthcare System. Participants A total of 106 opiate-dependent, Cocaine-abusing individuals. Interventions All study participants received methadone hydrochloride (range, 60-120 mg). Participants receiving bupropion hydrochloride were given 300 mg/d beginning at week 3. In the CM conditions, each urine sample negative for both opioids and Cocaine resulted in a monetary-based voucher that increased for consecutively drug-free urine samples during weeks 1 to 13. Completion of abstinence-related activities also resulted in a voucher. During weeks 14 to 25, only completion of activities was reinforced in the CM group, regardless of sample results. The voucher control groups received vouchers for submitting urine samples, regardless of results, throughout the study. Main Outcome Measure Thrice-weekly urine toxicologic test results for Cocaine and heroin. Results Groups did not differ in baseline characteristics or retention rates. Opiate use decreased significantly, with all treatment groups attaining equivalent amounts of opiate use at the end of the study. In the CMB group, the proportion of Cocaine-positive samples significantly decreased during weeks 3 to 13 ( P P P Conclusion These findings suggest that combining CM with bupropion for the treatment of Cocaine addiction may significantly improve outcomes relative to bupropion alone.
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quantitative morphology of the caudate and putamen in patients with Cocaine Dependence
American Journal of Psychiatry, 2001Co-Authors: Leslie K Jacobsen, Thomas R Kosten, Jay N Giedd, Christopher Gottschalk, John H KrystalAbstract:OBJECTIVE: Deficits in dopaminergic function may contribute to hypertrophy of striatal structures associated with typical neuroleptic treatment. In light of a body of research that has associated chronic Cocaine use with extrapyramidal symptoms and striatal dopaminergic depletion, the authors looked for evidence of striatal dysmorphology in patients with chronic Cocaine Dependence. METHOD: Caudate, putamen, and total brain volumes were quantified by means of magnetic resonance imaging in 25 Cocaine-dependent and 20 healthy subjects. RESULTS: Normalized caudate and putamen volumes were 3.40% and 9.18% larger, respectively, in the Cocaine-dependent subjects. CONCLUSIONS: These observations suggest that deficits in dopaminergic function associated with Cocaine Dependence may contribute to striatal hypertrophy.
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a randomized controlled trial of auricular acupuncture for Cocaine Dependence
JAMA Internal Medicine, 2000Co-Authors: S. Kelly Avants, Arthur Margolin, Theodore R. Holford, Thomas R KostenAbstract:Background Partly because of a lack of a conventional, effective treatment for Cocaine addiction, auricular acupuncture is used to treat this disorder in numerous drug treatment facilities across the country for both primary Cocaine-dependent and opiate-dependent populations. Objective To evaluate the effectiveness of auricular acupuncture for the treatment of Cocaine addiction. Methods Eighty-two Cocaine-dependent, methadone-maintained patients were randomly assigned to 1 of 3 conditions: auricular acupuncture, a needle-insertion control condition, or a no-needle relaxation control. Treatment sessions were provided 5 times weekly for 8 weeks. The primary outcome was Cocaine use assessed by 3-times-weekly urine toxicology screens. Results Longitudinal analysis of the urine data for the intent-to-treat sample showed that patients assigned to acupuncture were significantly more likely to provide Cocaine-negative urine samples relative to both the relaxation control (odds ratio, 3.41; 95% confidence interval, 1.33-8.72;P= .01) and the needle-insertion control (odds ratio, 2.40; 95% confidence interval, 1.00-5.75;P= .05). Conclusions Findings from the current study suggest that acupuncture shows promise for the treatment of Cocaine Dependence. Further investigation of this treatment modality appears to be warranted.
Charles A. Dackis - One of the best experts on this subject based on the ideXlab platform.
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a double blind placebo controlled trial of modafinil for the treatment of Cocaine Dependence without co morbid alcohol Dependence
Drug and Alcohol Dependence, 2015Co-Authors: Kyle M. Kampman, Kevin G Lynch, Charles A. Dackis, Helen M. Pettinati, Kelly Anne Spratt, Michael R Wierzbicki, Charles P ObrienAbstract:Background Modafinil is a medication approved for narcolepsy and shift work sleep disorder. It has both dopaminergic and glutamatergic activity that could be useful for the treatment of Cocaine Dependence. Modafinil has reduced Cocaine subjective effects and Cocaine self-administration in human laboratory trials and has reduced Cocaine use in Cocaine dependent patients in some clinical trials.
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a double blind placebo controlled trial of modafinil for Cocaine Dependence
Journal of Substance Abuse Treatment, 2012Co-Authors: Charles A. Dackis, Thorne Sparkman, Kevin G Lynch, Kyle M. Kampman, Helen M. Pettinati, Jennifer G Plebani, Charles P ObrienAbstract:Abstract This is a randomized, double-blind, placebo-controlled study of modafinil treatment for Cocaine Dependence. Patients ( N = 210) who were actively using Cocaine at baseline were randomized to 8 weeks of modafinil (0 mg/day, 200 mg/day, or 400 mg/day) combined with once-weekly cognitive–behavioral therapy. Our primary efficacy measure was Cocaine abstinence, based on urine benzoylecgonine (BE) levels, with secondary measures of craving, Cocaine withdrawal, retention, and tolerability. We found no significant differences between modafinil and placebo patients on any of these measures. However, there was a significant gender difference in that male patients treated with 400 mg/day tended to be more abstinent than their placebo-treated counterparts ( p = .06). Our negative findings might be explained by gender differences and/or inadequate psychosocial treatment intensity in patients with severe Cocaine Dependence.
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A double-blind, placebo-controlled pilot trial of acamprosate for the treatment of Cocaine Dependence.
Addictive Behaviors, 2010Co-Authors: Kyle M. Kampman, Thorne Sparkman, Kevin G Lynch, Charles A. Dackis, Helen M. Pettinati, Charles P. O'brienAbstract:Abstract Background Acamprosate is a medication shown to be effective for the treatment of alcohol Dependence. Although the exact mechanism of action of acamprosate is unknown, evidence suggests that it decreases excitatory amino acid activity by post-synaptic inhibition of the NMDA subtype of glutamate receptors. It is possible that the activity of acamprosate via modulating glutamatergic activity could also reduce craving for Cocaine and impact abstinence in Cocaine Dependence. Therefore, we conducted a double-blind placebo-controlled pilot trial of acamprosate for the treatment of Cocaine Dependence. Methods Sixty male and female Cocaine dependent patients were included in a nine week double-blind, placebo-controlled trial. After a one-week baseline, patients were randomized to receive acamprosate 666 mg three times daily or identical placebo tablets for eight weeks. The primary outcome measure was Cocaine use as determined by twice weekly urine drug screens. Results Thirty-six patients (60%) completed the trial, with no significant between-group difference in treatment retention. Percent Cocaine positive urine drug screens did not differ between the two groups. Acamprosate was no better than placebo in reducing Cocaine craving, reducing Cocaine withdrawal symptoms, or improving measures of drug use severity from the Addiction Severity Index. Adverse events in this trial were generally mild and were evenly distributed between the two groups. Discussion Acamprosate was well tolerated but was no more efficacious than placebo in promoting abstinence from Cocaine in Cocaine dependent patients. Acamprosate does not appear to be a promising medication for the treatment of Cocaine Dependence.
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genetic variants in the Cocaine and amphetamine regulated transcript gene cartpt and Cocaine Dependence
Neuroscience Letters, 2008Co-Authors: Falk W Lohoff, Kyle M. Kampman, Helen M. Pettinati, Paul J Bloch, Andrew E Weller, Aleksandra H Nall, Glenn A Doyle, Russell J Buono, Thomas N Ferraro, Charles A. DackisAbstract:Dopaminergic brain systems have been implicated to play a major role in drug reward, thus making genes involved in these circuits plausible candidates for susceptibility to substance use disorders. The Cocaine- and amphetamine-regulated transcript peptide (CARTPT) is involved in reward and feeding behavior and has functional characteristics of an endogenous psychostimulant. In this study we tested the hypothesis that variation in the CARTPT gene increases susceptibility to Cocaine Dependence in individuals of African descent. Genotypes of three HapMap tagging SNPs (rs6894758; rs11575893; rs17358300) across the CARTPT gene region were obtained in Cocaine dependent individuals (n=348) and normal controls (n=256). All subjects were of African descent. There were no significant differences in allele, genotype or haplotype frequencies between cases and controls for any of the tested SNPs. Our results do not support an association of the CARTPT gene with Cocaine Dependence; however, additional studies using larger samples, comprehensive SNP coverage, and different populations are necessary to conclusively rule out CARTPT as a contributing factor in the etiology of Cocaine Dependence.
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Cocaine withdrawal symptoms identify type b Cocaine dependent patients
American Journal on Addictions, 2008Co-Authors: Thorne Sparkman, Kyle M. Kampman, Charles A. Dackis, Jamshid Ahmadi, Helen M. PettinatiAbstract:Recent studies of substance Dependence typologies briefly show that multivariate systems originally developed for identifying subtypes of alcoholics, such as Babor's Type A and B system, may also be valid in abusers of other substances, such as Cocaine. Type B patients are characterized by an earlier onset of addiction and more severe symptoms of their addiction, psychopathology, and impulsivity. The Type B classification has also been associated with deficits in serotonergic function. We have found that patients who exhibit more severe Cocaine withdrawal symptoms, as measured by scores on the Cocaine Selective Severity Assessment (CSSA), have poor treatment outcome and share many characteristics with "Type B" patients. In this paper, we review baseline characteristics of Cocaine-dependent patients from several recently completed outpatient Cocaine Dependence treatment trials to assess the association of Cocaine withdrawal symptom severity and the Type B profile. Identifying subtypes of Cocaine-dependent patients may improve our ability to treat Cocaine Dependence by targeting treatments for specific subtypes of patients. We examined the ability of the CSSA scores to capture Type B characteristics in Cocaine Dependence by analyzing a series of Cocaine medication trials that included 255 Cocaine-dependent subjects. High CSSA scores at baseline were associated with a history of violent behavior, a family history of substance abuse, antisocial personality disorder, higher addiction severity, and co-morbid psychiatric diseases. Patients with high CSSA scores are also more likely to meet criteria for Type B (Type II) Cocaine Dependence. Identifying Type B Cocaine-dependent patients may help to develop targeted psychosocial or pharmacological treatments for these difficult-to-treat patients.