Phase 3
N=9
Buprenorphine Treatment for Opioid Dependence
Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02187198 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Urine Toxicology for Opiate Use — 2; 4; 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buprenorphine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urine Toxicology for Opiate Use |
2; 4; 2; 0; 1; 0 | — |
| PRIMARY Urine Toxicology |
3; 3; 1; 0; 1; 1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02187198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.