A Phase 3 interventional study of Buprenorphine/naloxone in Heroin Dependence, Morphine Dependence and Substance Withdrawal Syndrome, sponsored by University of California, Los Angeles. Completed at 7 sites in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2017-01-12.
Sponsored by University of California, Los Angeles · Phase 3, Interventional, and Treatment
The purpose of this study is to assess buprenorphine/naloxone versus clonidine for outpatient opiate detoxification.
Patients randomized to the BUP/NX arm will receive daily doses for 13 days with sublingual administration of 2 mg buprenorphine/0.5 mg naloxone tablet(s) and/or an 8 mg buprenorphine/2.0 mg naloxone tablet(s). The starting dose on day 1 is 4 mg/1 mg BUP/NX with an additional 4 mg/1 mg, if needed, escalating in a step-wise manner to 16 mg/4 mg BUP/NX on day 3 and tapering to 2 mg/ 0.5 mg BUP/NX by days 12 to 13. Patients randomized to the clonidine arm will receive oral clonidine (0.05 to 0.1 mg depending upon weight) every 4 to 6 hours for 24 hours not to exceed 0.6 mg total on day 1. On day 2, a clonidine transdermal patch will be applied (0.1 mg/day/7-day patch with number of patches adjusted by weight). Oral clonidine will continue to be given on the second day of detoxification and increased to 0.2 mg every 6 hours or 0.1 mg every 3 hours not to exceed 0.8 mg over 24 hours. Patches will be worn all 13 days of detoxification. The dose of clonidine will be adjusted according to the proposed detoxification schedule, patient's weight, tolerance, and systolic blood pressure. Patients will receive counseling according to procedures in existence at each CTP throughout the study. Self-help detoxification handbooks will be distributed to all study participants.
128 studies on the registry are indexed under Substance Withdrawal Syndrome; 8 are open to participants now.
This study's enrollment of 341 is above the median of 53 across 93 interventional studies indexed under Substance Withdrawal Syndrome.
Browse Substance Withdrawal Syndrome studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Use of one of the following acceptable methods of birth control by female patients of childbearing potential:
Exclusion Criteria:
Drug use
Degree of drug craving
Opiate craving
Adverse events
Drug craving
Decreased frequency of HIV related behavior
Adverse effect measures
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Substance Withdrawal Syndrome→
University of California, Los Angeles