Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1

Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00023283

Enrollment

Unknown

Registered

2001-08-31

Start date

2000-08-31

Completion date

2004-02-29

Last updated

2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heroin Dependence, Opioid-Related Disorders, Substance Abuse, Intravenous

Keywords

Opioid-Related Disorders

Brief summary

The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM)

Detailed description

A randomized trial, in a hospital primary care clinic, for 24 weeks, of 168 opioid-dependent subjects, maintained on buprenorphine 3x/week, and counseled with Standard or Enhanced Medical Management. SMM is a brief intervention similar to that provided by primary practitioners to patients with chronic medical conditions such as diabetes. EMM is an intervention that provides education about the recovery process and advice about lifestyle changes and 12-step participation. Outcome measures include reduction in opioid use and abstinence from opioids, documented by 3x/week urine testing and self report.

Interventions

DRUGBuprenorphine

1. Experimental Standard Medical Management with once-weekly medication dispensing 2. Experimental Standard Medical Management with thrice-weekly medication dispensing 3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Subjects meeting FDA criteria for opioid agonist maintenance treatment and DSM-IV criteria for opioid dependence will be eligible for the study. Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy monitoring throughout the study.

Exclusion criteria

include: pregnancy, current dependence on alcohol, benzodiazepines or sedatives; current suicide or homicide risk; current psychotic disorder or major depression; inability to read or understand English; life-threatening or unstable medical problems.

Design outcomes

Primary

Measure	Time frame
Self-reported frequency of illicit opioid use	6 months
Percentage of opioid-negative urine specimens	6 months
Maximum number of weeks abstinent from illicit opioids	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026