Buprenorphine Treatment for Opioid Dependence
Completed · Phase 3
Conditions studied: Opioid Dependence
In brief
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.
Key facts
- Study ID
- NCT02187198
- Run by
- Yale University
- People needed
- 9
- Starts
- 2015-03-01
- Expected to finish
- 2023-01-01
- Last updated by the study team
- 2023-03-10
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- VA Connecticut Healthcare System - West Haven Campus — West Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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