Buprenorphine Treatment for Opioid Dependence

• Status: Active, not recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: United States Department of Defense
• Treatments: Analgesics, Opioid; Buprenorphine; Naloxone

Criteria

Inclusion Criteria:

1. Males and females between the ages of 18 to 65, current dependence on prescription opioids as evidenced by documented prior treatment for opioid dependence, signs of opiate withdrawal as evidenced by a COWS score of 7 or greater, self-reported history of opioid dependence, and a positive urine toxicology for opiates;

2. willingness to be detoxified from opioids for buprenorphine maintenance ;

3. for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy, with monthly pregnancy tests obtained during study participation.

Exclusion Criteria:

1. use of heroin for more than 4 days in the past month;

2. lifetime history of opioid dependence due to heroin alone;

3. ever used heroin intravenously;

4. requirement for current ongoing opioid treatment for adequate pain management;

5. current alcohol, benzodiazepine, barbiturate use with physiologic dependence as determined during screening history and physical,

6. serious unstable medical illness including bradycardia or other arrhythmias, major cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine treatment is contraindicated or which at the determination of the MD is medically dangerous;

7. serious psychiatric illness including psychosis, bipolar disorder with psychosis:

8. or significant current suicidal or homicidal thoughts necessitating a higher level or care;

9. known allergy or intolerance to buprenorphine.