Overview

Buprenorphine Treatment for Opioid Dependence

Status:
Active, not recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
This is a randomized, open-label clinical trial with 200 Veteran opioid dependent men and women. Veterans will be randomized to one of two treatment groups: low dose range of buprenorphine (<8mg) vs. high dose range of buprenorphine (<16mg). During induction into buprenorphine, all participants will be started at a dose of 2mg, and this dose will be increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg for the low dose group, and up to 16mg for the high dose group, within a 5 day period. Participants will be seen on a daily basis (excluding weekends) for the initial 5 day induction. At the end of the 12-week study, participants will either be referred to a buprenorphine clinic if they wish to continue this medication, or if they wish to be drug free, will undergo detoxification from buprenorphine for up to a 4-week period. Follow-up visits, scheduled at 1, 3, and 6 months after study completion, will evaluate the durability of treatment effects on drug use and psychosocial outcomes. Veterans will be recruited primarily through advertisement, but also through the clinical facilities at the VA and from other collaborators.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Yale University
Collaborator:
United States Department of Defense
Treatments:
Analgesics, Opioid
Buprenorphine
Naloxone