The Experts below are selected from a list of 270 Experts worldwide ranked by ideXlab platform
Edward V. Nunes - One of the best experts on this subject based on the ideXlab platform.
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Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine.
The American journal of psychiatry, 2017Co-Authors: Maria A. Sullivan, Adam Bisaga, Martina Pavlicova, C. Jean Choi, Kaitlyn Mishlen, Kenneth M. Carpenter, Frances R. Levin, Elias Dakwar, John J. Mariani, Edward V. NunesAbstract:At present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection Naltrexone (XR-Naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-Naltrexone. Participants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, Naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-Naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral Naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-Naltrexone, consistent with official prescribing information for XR-Naltrexone. Participants from both groups received behavioral therapy focused on medication adherence and a second dose of XR-Naltrexone. Compared with participants in the buprenorphine-assisted detoxification condition, participants assigned to Naltrexone-assisted detoxification were significantly more likely to be successfully inducted to XR-Naltrexone (56.1% compared with 32.7%) and to receive the second injection at week 5 (50.0% compared with 26.9%). Both models adjusted for primary type of opioid use, route of opioid administration, and morphine equivalents at baseline. These results demonstrate the safety, efficacy, and tolerability of low-dose Naltrexone, in conjunction with single-day buprenorphine dosing and adjunctive nonopioid medications, for initiating adults with opioid dependence to XR-Naltrexone. This strategy offers a promising alternative to the high rates of attrition and relapse currently observed with agonist tapers in both inpatient and outpatient settings.
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long acting injectable Naltrexone induction a randomized trial of outpatient opioid detoxification with Naltrexone versus buprenorphine
American Journal of Psychiatry, 2017Co-Authors: Maria A. Sullivan, Adam Bisaga, Martina Pavlicova, Kaitlyn Mishlen, Kenneth M. Carpenter, Frances R. Levin, Elias Dakwar, John J. Mariani, Jean C Choi, Edward V. NunesAbstract:Objective:At present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection Naltrexone (XR-Naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-Naltrexone.Method:Participants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, Naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-Naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral Naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-Naltrexone, consistent with official prescribing information for XR-Naltrexone. Participants from both groups received behavio...
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long acting injectable versus oral Naltrexone maintenance therapy with psychosocial intervention for heroin dependence a quasi experiment
The Journal of Clinical Psychiatry, 2010Co-Authors: Adam C Brooks, Maria A. Sullivan, Adam Bisaga, Kenneth M. Carpenter, Sandra D Comer, Wilfrid M Raby, Charles P Obrien, Edward V. NunesAbstract:Objective To conduct a quasi-experimental comparison of early clinical outcomes between injectable, sustained-release, depot Naltrexone formulation versus oral Naltrexone maintenance therapy in individuals with opiate dependence. Method Early retention in treatment and urine-confirmed opiate use in the first 8 weeks postdetoxification were compared between patients (diagnosed as opiate-dependent according to DSM-IV criteria) participating in 2 concurrently run randomized clinical trials of oral (n = 69; patients treated from September 1999 to May 2002) and long-acting injectable (n = 42; patients treated from November 2000 to June 2003) Naltrexone maintenance therapy with psychosocial therapy. Results Long-acting injectable Naltrexone produced significantly better outcome than oral Naltrexone on days retained in treatment (F(1,106) = 6.49, P = .012) and for 1 measure of opiate use (F(1,106) = 5.26, P = .024); other measures were not significantly different, but differences were in the same direction. In subanalyses, there were interaction effects between baseline heroin use severity and type of treatment. In subanalyses, heroin users with more severe baseline use showed better retention with oral Naltrexone maintenance therapy combined with intensive psychotherapy (behavioral Naltrexone therapy) as compared to retention shown by severe heroin users treated with long-acting Naltrexone injections combined with standard cognitive-behavioral therapy (χ²(1)= 9.31, P = .002); less severe heroin users evidenced better outcomes when treated with long-acting injectable Naltrexone. Conclusions This quasi-experimental analysis provides tentative indications of superior outcomes for heroin-dependent patients treated with long-acting injectable Naltrexone compared to oral Naltrexone. The finding that heroin users with more severe baseline use achieved better outcomes with oral Naltrexone is most probably attributable to the intensive nature of the psychosocial treatments provided and points to the opportunity for continued research in augmenting injectable Naltrexone with psychosocial strategies to further improve outcome, especially in individuals with more severe use. The results should be considered exploratory given the quasi-experimental nature of the study.
Maria A. Sullivan - One of the best experts on this subject based on the ideXlab platform.
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Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine.
The American journal of psychiatry, 2017Co-Authors: Maria A. Sullivan, Adam Bisaga, Martina Pavlicova, C. Jean Choi, Kaitlyn Mishlen, Kenneth M. Carpenter, Frances R. Levin, Elias Dakwar, John J. Mariani, Edward V. NunesAbstract:At present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection Naltrexone (XR-Naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-Naltrexone. Participants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, Naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-Naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral Naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-Naltrexone, consistent with official prescribing information for XR-Naltrexone. Participants from both groups received behavioral therapy focused on medication adherence and a second dose of XR-Naltrexone. Compared with participants in the buprenorphine-assisted detoxification condition, participants assigned to Naltrexone-assisted detoxification were significantly more likely to be successfully inducted to XR-Naltrexone (56.1% compared with 32.7%) and to receive the second injection at week 5 (50.0% compared with 26.9%). Both models adjusted for primary type of opioid use, route of opioid administration, and morphine equivalents at baseline. These results demonstrate the safety, efficacy, and tolerability of low-dose Naltrexone, in conjunction with single-day buprenorphine dosing and adjunctive nonopioid medications, for initiating adults with opioid dependence to XR-Naltrexone. This strategy offers a promising alternative to the high rates of attrition and relapse currently observed with agonist tapers in both inpatient and outpatient settings.
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long acting injectable Naltrexone induction a randomized trial of outpatient opioid detoxification with Naltrexone versus buprenorphine
American Journal of Psychiatry, 2017Co-Authors: Maria A. Sullivan, Adam Bisaga, Martina Pavlicova, Kaitlyn Mishlen, Kenneth M. Carpenter, Frances R. Levin, Elias Dakwar, John J. Mariani, Jean C Choi, Edward V. NunesAbstract:Objective:At present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection Naltrexone (XR-Naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-Naltrexone.Method:Participants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, Naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-Naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral Naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-Naltrexone, consistent with official prescribing information for XR-Naltrexone. Participants from both groups received behavio...
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long acting injectable versus oral Naltrexone maintenance therapy with psychosocial intervention for heroin dependence a quasi experiment
The Journal of Clinical Psychiatry, 2010Co-Authors: Adam C Brooks, Maria A. Sullivan, Adam Bisaga, Kenneth M. Carpenter, Sandra D Comer, Wilfrid M Raby, Charles P Obrien, Edward V. NunesAbstract:Objective To conduct a quasi-experimental comparison of early clinical outcomes between injectable, sustained-release, depot Naltrexone formulation versus oral Naltrexone maintenance therapy in individuals with opiate dependence. Method Early retention in treatment and urine-confirmed opiate use in the first 8 weeks postdetoxification were compared between patients (diagnosed as opiate-dependent according to DSM-IV criteria) participating in 2 concurrently run randomized clinical trials of oral (n = 69; patients treated from September 1999 to May 2002) and long-acting injectable (n = 42; patients treated from November 2000 to June 2003) Naltrexone maintenance therapy with psychosocial therapy. Results Long-acting injectable Naltrexone produced significantly better outcome than oral Naltrexone on days retained in treatment (F(1,106) = 6.49, P = .012) and for 1 measure of opiate use (F(1,106) = 5.26, P = .024); other measures were not significantly different, but differences were in the same direction. In subanalyses, there were interaction effects between baseline heroin use severity and type of treatment. In subanalyses, heroin users with more severe baseline use showed better retention with oral Naltrexone maintenance therapy combined with intensive psychotherapy (behavioral Naltrexone therapy) as compared to retention shown by severe heroin users treated with long-acting Naltrexone injections combined with standard cognitive-behavioral therapy (χ²(1)= 9.31, P = .002); less severe heroin users evidenced better outcomes when treated with long-acting injectable Naltrexone. Conclusions This quasi-experimental analysis provides tentative indications of superior outcomes for heroin-dependent patients treated with long-acting injectable Naltrexone compared to oral Naltrexone. The finding that heroin users with more severe baseline use achieved better outcomes with oral Naltrexone is most probably attributable to the intensive nature of the psychosocial treatments provided and points to the opportunity for continued research in augmenting injectable Naltrexone with psychosocial strategies to further improve outcome, especially in individuals with more severe use. The results should be considered exploratory given the quasi-experimental nature of the study.
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management of relapse in Naltrexone maintenance for heroin dependence
Drug and Alcohol Dependence, 2007Co-Authors: Maria A. Sullivan, Adam Bisaga, Kenneth M. Carpenter, Sandra D Comer, Adam C Brooks, Fatima Garawi, Wilfrid N Raby, Stephen J Anen, Huiping Jiang, Evaristo AkereleAbstract:Abstract Opioid dependence is a growing public health problem. Maintenance on the antagonist Naltrexone for clinic- or office-based treatment of opioid dependence is plagued by high rates of relapse. This paper identifies critical determinants of lapses to opioid use during Naltrexone maintenance. Time retained in treatment was examined as a function of whether lapses to opioid use occurred while adherent to Naltrexone (blocked use), or after having missed Naltrexone doses (unblocked). Method Participants ( N = 83) met DSM-IV criteria for opioid dependence and identified a significant other willing to participate in their treatment. Following inpatient detoxification, participants were enrolled in a 26-week outpatient course of therapy and Naltrexone maintenance. Results Patients with unblocked use had a very high rate of dropout (10% retained at 6 months), dropout usually occurring within 2 weeks after unblocked use. Patients with only blocked use had less dropout (33% retained at 6 months). However, episodes of blocked use were often followed by unblocked use and dropout. Conclusions During Naltrexone maintenance for opioid dependence unblocked opioid use calls for immediate intervention, such as detoxification or switching to the partial agonist buprenorphine. Episodes of blocked use warrant increased clinical attention, such as direct observation of Naltrexone ingestion, increased dose, or increased intensity of treatment contact. Maintenance on oral Naltrexone is a fragile treatment because it is so easily undermined by episodes of opioid use while non-compliant. New long-acting injectable or implantable formulations of Naltrexone may address this limitation and should be investigated for treatment of opioid dependence.
Paula Pinheiro - One of the best experts on this subject based on the ideXlab platform.
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Vulvar Hailey–Hailey disease treated with low-dose Naltrexone: case report and literature review
Archives of Gynecology and Obstetrics, 2020Co-Authors: Marina Sousa Gomes, Joana Araújo Pereira, Vera Trocado, João Pedro Prata, Vera Teixeira, Paula PinheiroAbstract:Purpose To report a case of vulvar familial benign pemphigus, or Hailey–Hailey disease, treated successfully with low-dose Naltrexone and to review the current literature. Methods We report a case of a 71-year-old white woman with vulvar Hailey–Hailey disease recalcitrant to topical corticosteroids. After treatment with low-dose Naltrexone, 3 mg nightly was initiated, the lesions began to heal and 5 months later her skin showed no lesions. A literature review on the use of low-dose Naltrexone for Hailey–Hailey disease was performed. We searched the PubMed/MEDLINE databases for previous case reports using the key words ‘‘Pemphigus, Benign Familial’’ and ‘‘Naltrexone”. Results We found 35 more cases of Hailey–Hailey disease treated with Naltrexone, showing promising results, reported until January 2020, with no major adverse effects. Conclusion Low-dose Naltrexone may represent a cost-effective and successful treatment modality in nongeneralized Hailey–Hailey disease without serious adverse effects. Future prospective studies are needed to investigate this interesting therapeutic option.
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Vulvar Hailey–Hailey disease treated with low-dose Naltrexone: case report and literature review
Archives of Gynecology and Obstetrics, 2020Co-Authors: Marina Sousa Gomes, Joana Araújo Pereira, Vera Trocado, João Pedro Prata, Vera Teixeira, Paula PinheiroAbstract:Purpose To report a case of vulvar familial benign pemphigus, or Hailey–Hailey disease, treated successfully with low-dose Naltrexone and to review the current literature. Methods We report a case of a 71-year-old white woman with vulvar Hailey–Hailey disease recalcitrant to topical corticosteroids. After treatment with low-dose Naltrexone, 3 mg nightly was initiated, the lesions began to heal and 5 months later her skin showed no lesions. A literature review on the use of low-dose Naltrexone for Hailey–Hailey disease was performed. We searched the PubMed/MEDLINE databases for previous case reports using the key words ‘‘Pemphigus, Benign Familial’’ and ‘‘Naltrexone”. Results We found 35 more cases of Hailey–Hailey disease treated with Naltrexone, showing promising results, reported until January 2020, with no major adverse effects. Conclusion Low-dose Naltrexone may represent a cost-effective and successful treatment modality in nongeneralized Hailey–Hailey disease without serious adverse effects. Future prospective studies are needed to investigate this interesting therapeutic option.
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Vulvar Hailey-Hailey disease treated with low-dose Naltrexone: case report and literature review.
Archives of gynecology and obstetrics, 2020Co-Authors: Marina Sousa Gomes, Vera Trocado, João Pedro Prata, Vera Teixeira, Joana Pereira, Paula PinheiroAbstract:Purpose To report a case of vulvar familial benign pemphigus, or Hailey-Hailey disease, treated successfully with low-dose Naltrexone and to review the current literature. Methods We report a case of a 71-year-old white woman with vulvar Hailey-Hailey disease recalcitrant to topical corticosteroids. After treatment with low-dose Naltrexone, 3 mg nightly was initiated, the lesions began to heal and 5 months later her skin showed no lesions. A literature review on the use of low-dose Naltrexone for Hailey-Hailey disease was performed. We searched the PubMed/MEDLINE databases for previous case reports using the key words ''Pemphigus, Benign Familial'' and ''Naltrexone". Results We found 35 more cases of Hailey-Hailey disease treated with Naltrexone, showing promising results, reported until January 2020, with no major adverse effects. Conclusion Low-dose Naltrexone may represent a cost-effective and successful treatment modality in nongeneralized Hailey-Hailey disease without serious adverse effects. Future prospective studies are needed to investigate this interesting therapeutic option.
Adam Bisaga - One of the best experts on this subject based on the ideXlab platform.
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Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine.
The American journal of psychiatry, 2017Co-Authors: Maria A. Sullivan, Adam Bisaga, Martina Pavlicova, C. Jean Choi, Kaitlyn Mishlen, Kenneth M. Carpenter, Frances R. Levin, Elias Dakwar, John J. Mariani, Edward V. NunesAbstract:At present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection Naltrexone (XR-Naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-Naltrexone. Participants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, Naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-Naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral Naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-Naltrexone, consistent with official prescribing information for XR-Naltrexone. Participants from both groups received behavioral therapy focused on medication adherence and a second dose of XR-Naltrexone. Compared with participants in the buprenorphine-assisted detoxification condition, participants assigned to Naltrexone-assisted detoxification were significantly more likely to be successfully inducted to XR-Naltrexone (56.1% compared with 32.7%) and to receive the second injection at week 5 (50.0% compared with 26.9%). Both models adjusted for primary type of opioid use, route of opioid administration, and morphine equivalents at baseline. These results demonstrate the safety, efficacy, and tolerability of low-dose Naltrexone, in conjunction with single-day buprenorphine dosing and adjunctive nonopioid medications, for initiating adults with opioid dependence to XR-Naltrexone. This strategy offers a promising alternative to the high rates of attrition and relapse currently observed with agonist tapers in both inpatient and outpatient settings.
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long acting injectable Naltrexone induction a randomized trial of outpatient opioid detoxification with Naltrexone versus buprenorphine
American Journal of Psychiatry, 2017Co-Authors: Maria A. Sullivan, Adam Bisaga, Martina Pavlicova, Kaitlyn Mishlen, Kenneth M. Carpenter, Frances R. Levin, Elias Dakwar, John J. Mariani, Jean C Choi, Edward V. NunesAbstract:Objective:At present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection Naltrexone (XR-Naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-Naltrexone.Method:Participants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, Naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-Naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral Naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-Naltrexone, consistent with official prescribing information for XR-Naltrexone. Participants from both groups received behavio...
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long acting injectable versus oral Naltrexone maintenance therapy with psychosocial intervention for heroin dependence a quasi experiment
The Journal of Clinical Psychiatry, 2010Co-Authors: Adam C Brooks, Maria A. Sullivan, Adam Bisaga, Kenneth M. Carpenter, Sandra D Comer, Wilfrid M Raby, Charles P Obrien, Edward V. NunesAbstract:Objective To conduct a quasi-experimental comparison of early clinical outcomes between injectable, sustained-release, depot Naltrexone formulation versus oral Naltrexone maintenance therapy in individuals with opiate dependence. Method Early retention in treatment and urine-confirmed opiate use in the first 8 weeks postdetoxification were compared between patients (diagnosed as opiate-dependent according to DSM-IV criteria) participating in 2 concurrently run randomized clinical trials of oral (n = 69; patients treated from September 1999 to May 2002) and long-acting injectable (n = 42; patients treated from November 2000 to June 2003) Naltrexone maintenance therapy with psychosocial therapy. Results Long-acting injectable Naltrexone produced significantly better outcome than oral Naltrexone on days retained in treatment (F(1,106) = 6.49, P = .012) and for 1 measure of opiate use (F(1,106) = 5.26, P = .024); other measures were not significantly different, but differences were in the same direction. In subanalyses, there were interaction effects between baseline heroin use severity and type of treatment. In subanalyses, heroin users with more severe baseline use showed better retention with oral Naltrexone maintenance therapy combined with intensive psychotherapy (behavioral Naltrexone therapy) as compared to retention shown by severe heroin users treated with long-acting Naltrexone injections combined with standard cognitive-behavioral therapy (χ²(1)= 9.31, P = .002); less severe heroin users evidenced better outcomes when treated with long-acting injectable Naltrexone. Conclusions This quasi-experimental analysis provides tentative indications of superior outcomes for heroin-dependent patients treated with long-acting injectable Naltrexone compared to oral Naltrexone. The finding that heroin users with more severe baseline use achieved better outcomes with oral Naltrexone is most probably attributable to the intensive nature of the psychosocial treatments provided and points to the opportunity for continued research in augmenting injectable Naltrexone with psychosocial strategies to further improve outcome, especially in individuals with more severe use. The results should be considered exploratory given the quasi-experimental nature of the study.
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management of relapse in Naltrexone maintenance for heroin dependence
Drug and Alcohol Dependence, 2007Co-Authors: Maria A. Sullivan, Adam Bisaga, Kenneth M. Carpenter, Sandra D Comer, Adam C Brooks, Fatima Garawi, Wilfrid N Raby, Stephen J Anen, Huiping Jiang, Evaristo AkereleAbstract:Abstract Opioid dependence is a growing public health problem. Maintenance on the antagonist Naltrexone for clinic- or office-based treatment of opioid dependence is plagued by high rates of relapse. This paper identifies critical determinants of lapses to opioid use during Naltrexone maintenance. Time retained in treatment was examined as a function of whether lapses to opioid use occurred while adherent to Naltrexone (blocked use), or after having missed Naltrexone doses (unblocked). Method Participants ( N = 83) met DSM-IV criteria for opioid dependence and identified a significant other willing to participate in their treatment. Following inpatient detoxification, participants were enrolled in a 26-week outpatient course of therapy and Naltrexone maintenance. Results Patients with unblocked use had a very high rate of dropout (10% retained at 6 months), dropout usually occurring within 2 weeks after unblocked use. Patients with only blocked use had less dropout (33% retained at 6 months). However, episodes of blocked use were often followed by unblocked use and dropout. Conclusions During Naltrexone maintenance for opioid dependence unblocked opioid use calls for immediate intervention, such as detoxification or switching to the partial agonist buprenorphine. Episodes of blocked use warrant increased clinical attention, such as direct observation of Naltrexone ingestion, increased dose, or increased intensity of treatment contact. Maintenance on oral Naltrexone is a fragile treatment because it is so easily undermined by episodes of opioid use while non-compliant. New long-acting injectable or implantable formulations of Naltrexone may address this limitation and should be investigated for treatment of opioid dependence.
Kenneth M. Carpenter - One of the best experts on this subject based on the ideXlab platform.
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Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine.
The American journal of psychiatry, 2017Co-Authors: Maria A. Sullivan, Adam Bisaga, Martina Pavlicova, C. Jean Choi, Kaitlyn Mishlen, Kenneth M. Carpenter, Frances R. Levin, Elias Dakwar, John J. Mariani, Edward V. NunesAbstract:At present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection Naltrexone (XR-Naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-Naltrexone. Participants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, Naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-Naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral Naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-Naltrexone, consistent with official prescribing information for XR-Naltrexone. Participants from both groups received behavioral therapy focused on medication adherence and a second dose of XR-Naltrexone. Compared with participants in the buprenorphine-assisted detoxification condition, participants assigned to Naltrexone-assisted detoxification were significantly more likely to be successfully inducted to XR-Naltrexone (56.1% compared with 32.7%) and to receive the second injection at week 5 (50.0% compared with 26.9%). Both models adjusted for primary type of opioid use, route of opioid administration, and morphine equivalents at baseline. These results demonstrate the safety, efficacy, and tolerability of low-dose Naltrexone, in conjunction with single-day buprenorphine dosing and adjunctive nonopioid medications, for initiating adults with opioid dependence to XR-Naltrexone. This strategy offers a promising alternative to the high rates of attrition and relapse currently observed with agonist tapers in both inpatient and outpatient settings.
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long acting injectable Naltrexone induction a randomized trial of outpatient opioid detoxification with Naltrexone versus buprenorphine
American Journal of Psychiatry, 2017Co-Authors: Maria A. Sullivan, Adam Bisaga, Martina Pavlicova, Kaitlyn Mishlen, Kenneth M. Carpenter, Frances R. Levin, Elias Dakwar, John J. Mariani, Jean C Choi, Edward V. NunesAbstract:Objective:At present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection Naltrexone (XR-Naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-Naltrexone.Method:Participants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, Naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-Naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral Naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-Naltrexone, consistent with official prescribing information for XR-Naltrexone. Participants from both groups received behavio...
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long acting injectable versus oral Naltrexone maintenance therapy with psychosocial intervention for heroin dependence a quasi experiment
The Journal of Clinical Psychiatry, 2010Co-Authors: Adam C Brooks, Maria A. Sullivan, Adam Bisaga, Kenneth M. Carpenter, Sandra D Comer, Wilfrid M Raby, Charles P Obrien, Edward V. NunesAbstract:Objective To conduct a quasi-experimental comparison of early clinical outcomes between injectable, sustained-release, depot Naltrexone formulation versus oral Naltrexone maintenance therapy in individuals with opiate dependence. Method Early retention in treatment and urine-confirmed opiate use in the first 8 weeks postdetoxification were compared between patients (diagnosed as opiate-dependent according to DSM-IV criteria) participating in 2 concurrently run randomized clinical trials of oral (n = 69; patients treated from September 1999 to May 2002) and long-acting injectable (n = 42; patients treated from November 2000 to June 2003) Naltrexone maintenance therapy with psychosocial therapy. Results Long-acting injectable Naltrexone produced significantly better outcome than oral Naltrexone on days retained in treatment (F(1,106) = 6.49, P = .012) and for 1 measure of opiate use (F(1,106) = 5.26, P = .024); other measures were not significantly different, but differences were in the same direction. In subanalyses, there were interaction effects between baseline heroin use severity and type of treatment. In subanalyses, heroin users with more severe baseline use showed better retention with oral Naltrexone maintenance therapy combined with intensive psychotherapy (behavioral Naltrexone therapy) as compared to retention shown by severe heroin users treated with long-acting Naltrexone injections combined with standard cognitive-behavioral therapy (χ²(1)= 9.31, P = .002); less severe heroin users evidenced better outcomes when treated with long-acting injectable Naltrexone. Conclusions This quasi-experimental analysis provides tentative indications of superior outcomes for heroin-dependent patients treated with long-acting injectable Naltrexone compared to oral Naltrexone. The finding that heroin users with more severe baseline use achieved better outcomes with oral Naltrexone is most probably attributable to the intensive nature of the psychosocial treatments provided and points to the opportunity for continued research in augmenting injectable Naltrexone with psychosocial strategies to further improve outcome, especially in individuals with more severe use. The results should be considered exploratory given the quasi-experimental nature of the study.
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management of relapse in Naltrexone maintenance for heroin dependence
Drug and Alcohol Dependence, 2007Co-Authors: Maria A. Sullivan, Adam Bisaga, Kenneth M. Carpenter, Sandra D Comer, Adam C Brooks, Fatima Garawi, Wilfrid N Raby, Stephen J Anen, Huiping Jiang, Evaristo AkereleAbstract:Abstract Opioid dependence is a growing public health problem. Maintenance on the antagonist Naltrexone for clinic- or office-based treatment of opioid dependence is plagued by high rates of relapse. This paper identifies critical determinants of lapses to opioid use during Naltrexone maintenance. Time retained in treatment was examined as a function of whether lapses to opioid use occurred while adherent to Naltrexone (blocked use), or after having missed Naltrexone doses (unblocked). Method Participants ( N = 83) met DSM-IV criteria for opioid dependence and identified a significant other willing to participate in their treatment. Following inpatient detoxification, participants were enrolled in a 26-week outpatient course of therapy and Naltrexone maintenance. Results Patients with unblocked use had a very high rate of dropout (10% retained at 6 months), dropout usually occurring within 2 weeks after unblocked use. Patients with only blocked use had less dropout (33% retained at 6 months). However, episodes of blocked use were often followed by unblocked use and dropout. Conclusions During Naltrexone maintenance for opioid dependence unblocked opioid use calls for immediate intervention, such as detoxification or switching to the partial agonist buprenorphine. Episodes of blocked use warrant increased clinical attention, such as direct observation of Naltrexone ingestion, increased dose, or increased intensity of treatment contact. Maintenance on oral Naltrexone is a fragile treatment because it is so easily undermined by episodes of opioid use while non-compliant. New long-acting injectable or implantable formulations of Naltrexone may address this limitation and should be investigated for treatment of opioid dependence.
