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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00595764
Other study ID # 0504027657
Secondary ID 5R01DA019511
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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