Buprenorphine Treatment for Opioid Dependence

Yale University

Status and phase: Completed; Phase 3

Conditions: Opioid Dependence

Treatments: Drug: Buprenorphine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02187198

IP0040

Details and patient eligibility

About

Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this patient population. The goal of this study is to determine if there are differences in clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will be treatment retention, use of opioids, and the use of other drugs of abuse.

Full description

This is a randomized, open-label clinical trial with approximately 9 Veteran opioid dependent men and women. Veterans were randomized to one of two treatment groups: low dose range of buprenorphine (<8mg) vs. high dose range of buprenorphine/naloxone (BUP/NLX (<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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 Clinical Opiate Withdrawal Scale 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Buprenorphine low dose

Experimental group

Description:

Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.

Treatment:

Drug: Buprenorphine

Buprenorphine high dose

Experimental group

Description:

Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.

Treatment:

Drug: Buprenorphine