Phase 4
N=141
Counseling for Primary Care Office-based Buprenorphine
Opiate Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00595764 ↗Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Illicit Opioid Abstinence — 10.29; 10.12 Weeks of Abstinence — p=.91
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Manual-guided Physician Management (PM) (Behavioral); Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Illicit Opioid Abstinence |
10.29; 10.12 | .91 |
| SECONDARY Treatment Completion |
45; 39 | — |
| SECONDARY Cocaine Abstinence |
12.4; 13.8 | .29 |
| SECONDARY Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score. |
.044; .066 | .58 |
| SECONDARY Overall Health- Short Form (36) Health Survey |
75.3; 75.1 | .24 |
Summary
The major goal is to determine whether adding cognitive behavioral therapy to physician management will increase the efficacy of buprenorphine/naloxone treatment in an office-based primary care setting.
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 (NCT00595764). 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.