Counseling for Primary Care Office-based Buprenorphine

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

NCT00555425

Opiate Dependence

COMPLETED PHASE4

Buprenorphine for Prisoners

NCT00574067

Heroin Addiction

COMPLETED PHASE3

Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care

NCT00471042

Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous

COMPLETED

CBT4CBT for Office Based Buprenorphine

NCT03580902

Opioid-use Disorder

COMPLETED PHASE1/PHASE2

Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

NCT00023283

Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opiate Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Physician Management

Group Type ACTIVE_COMPARATOR

Manual-guided Physician Management (PM)

Intervention Type 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.

2

Physician Management plus Cognitive Behavioral Therapy

Group Type EXPERIMENTAL

Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No