Status:
COMPLETED
Buprenorphine Treatment for Opioid Dependence
Lead Sponsor:
Yale University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Opioid Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 populatio...
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 (\...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02187198
Start Date
March 1 2015
End Date
January 1 2023
Last Update
March 10 2023
Active Locations (1)
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1
VA Connecticut Healthcare System - West Haven Campus
West Haven, Connecticut, United States, 06516