Lisa A Marsch1, Sarah K Moore2, Jacob T Borodovsky1, Ramon Solhkhah3, Gary J Badger4, Shelby Semino5, Kate Jarrett6, Kathleen DiGangi Condon7, Kate Rossettie8, Phillip Vincent3, Neda Hajizadeh6, Elizabeth Ducat9. 1. Center for Technology and Behavioral Health, Dartmouth Psychiatric Research Center, Dartmouth College, Lebanon, NH, USA. 2. Center for Comprehensive Pain Management and Palliative Care, Capital Health Medical Center, Pennington, NJ, USA. 3. Department of Psychiatry, Jersey Shore University Medical Center, Neptune, NJ, USA. 4. Department of Medical Biostatistics, University of Vermont, Burlington, VT, USA. 5. New York Public Library, New York, NY, USA. 6. Behavioral Science Research Unit, Mount Sinai St Luke's Hospital, New York, NY, USA. 7. Department of Medicine Division of Palliative Medicine and Bioethics, Winthrop University Hospital, Mineola, VT, USA. 8. Hudson Psychiatric Associates, Hoboken, NJ, USA. 9. Laboratory of Biology of Addictive Diseases Studies, The Rockefeller University, New York, NY, USA.
Abstract
BACKGROUND AND AIMS: Few randomized controlled trials have evaluated buprenorphine treatment interventions for opioid-dependent youth. Consequently, optimal administration strategies for this cohort are unclear. Our aim was to evaluate the relative efficacy of two different buprenorphine taper lengths in promoting abstinence from illicit opioids and treatment retention among opioid-dependent youth. DESIGN: A double-blind, placebo controlled, multicenter randomized controlled trial. SETTING:Two hospital-based research clinics (Manhattan and Brooklyn) in New York City, USA from 2005 to 2010. PARTICIPANTS: Volunteer sample of 53 primarily Caucasian participants between the ages of 16 and 24 (n = 11 under age 18) who met DSM-IV opioid dependence criteria. INTERVENTION: Participants were assigned randomly to either a 28-day buprenorphine taper (n = 28) or 56-day buprenorphine taper (n = 25) via a parallel-groups design during a 63-day period. Both groups received behavioral counseling and opioid abstinence incentives. Both taper conditions had a minimum of 1 week of placebo dosing at the end of the taper. MEASUREMENTS: The primary outcome was opioid abstinence measured as a percentage of scheduled urine toxicology tests documented to be negative for opioids. The secondary outcome was treatment retention, measured as number of days attended scheduled visits. FINDINGS: Intent-to-treat analyses revealed that participants who received a 56-day buprenorphine taper had a significantly higher percentage of opioid-negative scheduled urine tests compared with participants who received a 28-day buprenorphine taper [35 versus 17%, P = 0.039; Cohen's d = 0.57, 95% confidence interval (CI) = 0.02, 1.13]. Participants who received a 56-day buprenorphine taper were retained in treatment significantly longer than participants who received a 28-day buprenorphine taper (37.5 versus 26.4 days, P = 0.027; Cohen's d = 0.63, 95% CI = 0.06, 1.19). Daily attendance requirement was associated with decreased abstinence and shorter retention compared with a two to three times weekly attendance requirement, independent of taper duration. Follow-up data were insufficient to report. CONCLUSION: Longer (56-day) buprenorphine taper produces better opioid abstinence and retention outcomes than shorter (28-day) buprenorphinetaper for opioid-dependent youth.
RCT Entities:
BACKGROUND AND AIMS: Few randomized controlled trials have evaluated buprenorphine treatment interventions for opioid-dependent youth. Consequently, optimal administration strategies for this cohort are unclear. Our aim was to evaluate the relative efficacy of two different buprenorphine taper lengths in promoting abstinence from illicit opioids and treatment retention among opioid-dependent youth. DESIGN: A double-blind, placebo controlled, multicenter randomized controlled trial. SETTING: Two hospital-based research clinics (Manhattan and Brooklyn) in New York City, USA from 2005 to 2010. PARTICIPANTS: Volunteer sample of 53 primarily Caucasian participants between the ages of 16 and 24 (n = 11 under age 18) who met DSM-IV opioid dependence criteria. INTERVENTION: Participants were assigned randomly to either a 28-day buprenorphine taper (n = 28) or 56-day buprenorphine taper (n = 25) via a parallel-groups design during a 63-day period. Both groups received behavioral counseling and opioid abstinence incentives. Both taper conditions had a minimum of 1 week of placebo dosing at the end of the taper. MEASUREMENTS: The primary outcome was opioid abstinence measured as a percentage of scheduled urine toxicology tests documented to be negative for opioids. The secondary outcome was treatment retention, measured as number of days attended scheduled visits. FINDINGS: Intent-to-treat analyses revealed that participants who received a 56-day buprenorphine taper had a significantly higher percentage of opioid-negative scheduled urine tests compared with participants who received a 28-day buprenorphine taper [35 versus 17%, P = 0.039; Cohen's d = 0.57, 95% confidence interval (CI) = 0.02, 1.13]. Participants who received a 56-day buprenorphine taper were retained in treatment significantly longer than participants who received a 28-day buprenorphine taper (37.5 versus 26.4 days, P = 0.027; Cohen's d = 0.63, 95% CI = 0.06, 1.19). Daily attendance requirement was associated with decreased abstinence and shorter retention compared with a two to three times weekly attendance requirement, independent of taper duration. Follow-up data were insufficient to report. CONCLUSION: Longer (56-day) buprenorphine taper produces better opioid abstinence and retention outcomes than shorter (28-day) buprenorphine taper for opioid-dependent youth.
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