Chronic Pain Clinical Trial
— PODOfficial title:
Clinical Trial of Integrated Treatment for Pain and Opioid Dependence
Verified date | July 2021 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.
Status | Completed |
Enrollment | 90 |
Est. completion date | August 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Methadone Research Unit | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Intensity | Pain intensity comprises the average of 4 items related to current pain and past-week average pain, pain at its worst, and pain at its least. Pain intensity is scored on 0-10 scale (average score ranges from 0-10), where higher scores indicate higher pain intensity.Originally labeled as Pain Reduction at 16 weeks- 3 months was the correct timeframe. | 3 months | |
Primary | Number of Opioid-negative Urine Toxicology Tests | Reduced illicit opioid use is defined as the number of documented opioid negative urine tests in each of the time periods.This measures the reduction in illicit opioid use - more opioid-negative tests means greater reductions in illicit opioid use. The highest possible score is 4- which would indicate 4 negative urine tests during the assessment period. Originally titled "Reduced illicit opioid use" and the timeframe was listed as 16 weeks. | 3 Months | |
Primary | Pain Interference | Pain interference comprises the average of 7 items related to past-week pain-related interference in general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. Each item is scored on a 0-10 scale (averaged 0-10), where higher scores indicate higher pain interference. | 3 Months |
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