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Completed

NCT Number: NCT00595764

Counseling for Primary Care Office-based Buprenorphine

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.

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The APT Foundation, Inc. -- Welch Building, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual-guided Physician Management (PM)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Illicit Opioid Abstinence

    Time frame: 6 months

    number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.

Secondary outcomes

  1. Treatment Completion

    Time frame: 6 months

    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.

  2. Cocaine Abstinence

    Time frame: 6 months

    Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.

  3. Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.

    Time frame: 6 months

    The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.

  4. Overall Health- Short Form (36) Health Survey

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jan 16, 2008
Registry last updated
Apr 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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