Phase 2
N=90
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
Opiate Dependence · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT00634803 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Pain Intensity — 5.43; 5.92; 5.28; 4.75 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CBT (Behavioral); Buprenorphine (Drug); Educational Counseling (Other); Physician Management (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity |
5.43; 5.92; 5.28; 4.75; 5.02; 4.53 | — |
| PRIMARY Number of Opioid-negative Urine Toxicology Tests |
0.67; 0.67; 0.55; 2.67; 2.80; 2.48 | — |
| PRIMARY Pain Interference |
5.75; 5.48; 5.01; 4.15; 3.74; 3.32 | — |
Summary
This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- prescription opioid addiction criteria
- moderate to severe chronic pain
- seeking or interested in buprenorphine maintenance
- understand English
Exclusion Criteria
- methadone maintenance at a dose greater than 40 mg daily
- current suicide or homicide risk
- life-threatening or unstable medical problem
- pregnancy
Data sourced from ClinicalTrials.gov (NCT00634803). 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.