Counseling for Primary Care Office-based Buprenorphine

Opiate Dependence Clinical Trial

Official title:

Counseling for Primary Care Office-based Buprenorphine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595764
• Other study ID #: 0504027657
• Secondary ID: 5R01DA019511
• Status: Completed
• Phase: Phase 4
• Start date: August 2005
• Est. completion date: February 2011

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00632151

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders

Intervention

Behavioral:
• Manual-guided Physician Management (PM)
Manual-guided Physician Management (PM) PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services.
• Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)
CBT is provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Buprenorphine adherence.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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