Phase 4
N=113
Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence
Opiate Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00555425 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Illicit Opioid Use — 35.2; 53.2 percent of opioid negative urine samples
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Behavioral: Buprenorphine/naloxone maintenance (Mtn) (Behavioral); Behavioral: Buprenorphine/naloxone detoxification (Dtx) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Illicit Opioid Use |
35.2; 53.2 | — |
| SECONDARY Proportion of Patients Protectively Transferred |
16; 3 | — |
| SECONDARY Retention in Treatment |
57.5; 98.7 | — |
| SECONDARY Reduction in Cocaine Use |
11.5; 11.1 | — |
| SECONDARY Changes in HIV Risk |
66.7; 67.6; 74.5; 74.4 | — |
| SECONDARY Patient Satisfaction |
78.7; 79.9 | — |
| SECONDARY Health Status |
67.2; 67.6; 68.7; 66.6 | — |
Summary
The aim of the study is to determine whether buprenorphine/naloxone maintenance versus detoxification using buprenorphine/naloxone, in prescription opioid dependent patients receiving primary care management and drug counseling in an office-based setting, leads to decreased illicit opioid use.
Eligibility Criteria
Inclusion Criteria
- opioid dependence
Exclusion Criteria
- current dependence on alcohol, cocaine, benzodiazepines or sedatives
- current suicide or homicide risk
- current psychotic disorder or untreated major depression
- inability to read or understand English
- life-threatening or unstable medical problems
Data sourced from ClinicalTrials.gov (NCT00555425). 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.