Opiate Dependence Clinical Trial
Official title:
Counseling for Primary Care Office-based Buprenorphine
Verified date | April 2020 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 141 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | The APT Foundation, Inc. -- Welch Building | New Haven | Connecticut |
United States | Yale New Haven Hospital Primary Care Center | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA) |
United States,
Fiellin DA, Barry DT, Sullivan LE, Cutter CJ, Moore BA, O'Connor PG, Schottenfeld RS. A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine. Am J Med. 2013 Jan;126(1):74.e11-7. doi: 10.1016/j.amjmed.2012.07.005. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Illicit Opioid Abstinence | number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24. | 6 months | |
Secondary | Treatment Completion | The number of patients who completed the study (did not meet the criteria for protective transfer baseed on drug use, did not miss medication for more than seven days, or did not miss three or more Physician Management sessions) at 24 weeks. | 6 months | |
Secondary | Cocaine Abstinence | Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24. | 6 months | |
Secondary | Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score. | The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems. | 6 months | |
Secondary | Overall Health- Short Form (36) Health Survey | Short Form (36) Health Survey overall score ranges from 0 to 100. Computed as the mean of all SF-36 subscales. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Lower scores are greater disability and higher scores are greater health functioning. |
6 months |
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