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Buprenorphine Treatment for Opioid Dependence

Primary Purpose

Opioid Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence focused on measuring Opioid Dependence, Buprenorphine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • VA Connecticut Healthcare System - West Haven Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Buprenorphine low dose

Buprenorphine high dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

Urine Toxicology for Opiate Use
Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Urine Toxicology
Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)

Secondary Outcome Measures

Full Information

First Posted
July 8, 2014
Last Updated
March 8, 2023
Sponsor
Yale University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT02187198
Brief Title
Buprenorphine Treatment for Opioid Dependence
Official Title
Buprenorphine Treatment for Prescription Opioid Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
Keywords
Opioid Dependence, Buprenorphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buprenorphine low dose
Arm Type
Experimental
Arm Description
Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.
Arm Title
Buprenorphine high dose
Arm Type
Experimental
Arm Description
Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
Naloxone, Suboxone, Buprenex, Subutex
Primary Outcome Measure Information:
Title
Urine Toxicology for Opiate Use
Description
Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Time Frame
Weeks 1-12
Title
Urine Toxicology
Description
Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)
Time Frame
Weeks 1-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; willingness to be detoxified from opioids for buprenorphine maintenance ; 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: use of heroin for more than 4 days in the past month; lifetime history of opioid dependence due to heroin alone; ever used heroin intravenously; requirement for current ongoing opioid treatment for adequate pain management; current alcohol, benzodiazepine, barbiturate use with physiologic dependence as determined during screening history and physical, 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; serious psychiatric illness including psychosis, bipolar disorder with psychosis: or significant current suicidal or homicidal thoughts necessitating a higher level or care; known allergy or intolerance to buprenorphine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Ralevski, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System - West Haven Campus
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Buprenorphine Treatment for Opioid Dependence

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