Buprenorphine Treatment for Opioid Dependence

March 8, 2023 updated by: Yale University

Buprenorphine Treatment for Prescription Opioid Dependence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System - West Haven Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buprenorphine low dose
Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.
Drug: Buprenorphine
Other Names:
  • Subutex
  • Suboxone
  • Buprenex
  • Naloxone
Experimental: Buprenorphine high dose
Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.
Drug: Buprenorphine
Other Names:
  • Subutex
  • Suboxone
  • Buprenex
  • Naloxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine Toxicology for Opiate Use
Time Frame: Weeks 1-12
Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Weeks 1-12
Urine Toxicology
Time Frame: Weeks 1-12
Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Weeks 1-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

United States Department of Defense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

July 8, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP0040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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