Buprenorphine Treatment for Opioid Dependence

NCT ID: NCT02187198

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2023-01-01

Brief Summary

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.

Detailed 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.

Conditions

Opioid Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Buprenorphine low dose

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

Group Type: EXPERIMENTAL

Buprenorphine

Intervention Type: DRUG

Buprenorphine high dose

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

Group Type: EXPERIMENTAL

Buprenorphine

Intervention Type: DRUG

Interventions

Buprenorphine

Intervention Type: DRUG

Other Intervention Names

Naloxone; Suboxone; Buprenex; Subutex

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Ralevski, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

VA Connecticut Healthcare System - West Haven Campus

West Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IP0040

Identifier Type: -

Identifier Source: org_study_id