TY - JOUR KW - Administration, Oral KW - Adolescent KW - Adult KW - Ambulatory Care KW - Behavior Therapy KW - Buprenorphine/administration & dosage KW - Clonidine/administration & dosage KW - Combined Modality Therapy KW - Delayed-Action Preparations KW - Dose-Response Relationship, Drug KW - Drug Therapy, Combination KW - Female KW - Humans KW - Injections, Intramuscular KW - Male KW - Middle Aged KW - Naltrexone/administration & dosage KW - Opioid-Related Disorders/rehabilitation KW - Remission Induction KW - Secondary prevention KW - Young Adult KW - buprenorphine KW - Detoxification KW - Injectable naltrexone KW - Naltrexone KW - opioid dependence KW - Outpatient AU - Maria Sullivan AU - Adam Bisaga AU - Martina Pavlicova AU - Jean Choi AU - Kaitlyn Mishlen AU - Kenneth M. Carpenter AU - Frances R. Levin AU - Elias Dakwar AU - John J. Mariani AU - Edward V. Nunes A1 - AB - 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 behavioral therapy focused on medication adherence and a second dose of XR-naltrexone. RESULTS: 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. CONCLUSIONS: 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. AD - From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.; From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.; From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.; From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.; From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.; From the Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York; New York State Psychiatric Institute, New York; the Department of Biostatistics, Mailman School of Public Health, Columbia University and New York State Psychiatric Institute, New York; and Alkermes, Waltham, Mass.; From the Department of Psychiatry, College of Physicians and Surgeons(TRUNCATED) BT - The American Journal of Psychiatry C5 - Opioids & Substance Use CP - 5 CY - United States DO - 10.1176/appi.ajp.2016.16050548 IS - 5 JF - The American Journal of Psychiatry LA - eng M1 - Journal Article N2 - 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 behavioral therapy focused on medication adherence and a second dose of XR-naltrexone. RESULTS: 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. CONCLUSIONS: 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. PP - United States PY - 2017 SN - 1535-7228; 0002-953X SP - 459 EP - 467 EP - T1 - Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine T2 - The American Journal of Psychiatry TI - Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine U1 - Opioids & Substance Use U2 - 28068780 U3 - 10.1176/appi.ajp.2016.16050548 VL - 174 VO - 1535-7228; 0002-953X Y1 - 2017 Y2 - May 1 ER -