Clinical trial NCT00595764: Counseling for Primary Care Office-based Buprenorphine
Official title: Counseling for Primary Care Office-based Buprenorphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opiate Dependence
Keywords: Buprenorphine
Buprenorphine/naloxone
Counseling
Primary care
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-01-16
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing buprenorphine/naloxone adherence, the proposed study compares manual-guided Physician Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in a 24 week randomized clinical trial of buprenorphine/naloxone in a heterogeneous population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services. CBT will be provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing buprenorphine/naloxone adherence. The study will test the hypothesis that that the addition of CBT to PM will lead to decreased illicit drug use, durable effects after counseling has been discontinued, improved buprenorphine/naloxone adherence and will demonstrate incremental cost-effectiveness in patients receiving buprenorphine/naloxone maintenance in primary care. Primary outcome measures include reductions in illicit opioid use and abstinence achievement, as assessed by weekly urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, decreased criminal activity and improved health and employment status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems associated with primary care agonist maintenance treatment will also be evaluated. The results of this study will help define the role of professional evidence-based drug counseling in expanding access to treatment with buprenorphine/naloxone.

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

Primary outcomes:
measure: Illicit Opioid Abstinence
timeFrame: 6 months
Secondary outcomes:
measure: Treatment Completion
timeFrame: 6 months
measure: Cocaine Abstinence
timeFrame: 6 months
measure: Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.
timeFrame: 6 months
measure: Overall Health- Short Form (36) Health Survey
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The APT Foundation, Inc. -- Welch Building
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital Primary Care Center
state: Connecticut
Study officials:
affiliation: Yale University
name: David A. Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.