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Clinical Trials/NCT00877331
NCT00877331CompletedNot Applicable

Brief Intervention in Primary Care for Problem Drug Use and Abuse

University of Washington1 site in 1 country868 target enrollmentStarted: April 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
868
Locations
1
Primary Endpoint
Enrollment in formal substance abuse treatment

Study Overview

Brief Summary

This study will examine the effectiveness of a brief intervention in a primary care setting to reduce drug use or abuse compared to enhanced care as usual.

Detailed Description

A substantial body of research has established the efficacy and effectiveness of brief interventions (BI) for excessive or "hazardous" alcohol use in patients seen in medical settings. Dissemination projects of brief interventions for alcohol and drugs have recently been implemented on a widespread scale. This rapid progression of brief intervention for drugs other than alcohol has outstripped its evidence base.

The aims of the study as outlined in the grant are:

  1. To examine whether BI is effective at improving outcomes (self-reported drug use and attendance in drug abuse treatment) in individuals with a wide range of problem drug use over and above enhanced care as usual. The enhanced control condition will consist of routine screening, patient notification, and referral for treatment.
  2. To test whether fidelity to the BI model or lower severity of drug use is associated with better outcomes.
  3. To estimate the impact of BI on several public health outcomes that are directly related to the hazardous effects of illicit drug use, including the use of acute health care services, involvement in the criminal justice system, employment, HIV risk behavior, and mortality.
  4. To estimate the costs of the intervention, potential cost offsets, and its incremental cost-effectiveness versus enhanced usual care from the payer perspective based on health care service use and drug use frequency.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •at least 18 years old
  • •receive medical care at one of the participating primary care clinics at Harborview Medical Center/University of Washington Medical Center
  • •will maintain care at the clinic for one year
  • •have a phone or easy access to phone, voicemail, or email
  • •used recreational drugs in the last 3 months
  • •used prescription medications not as prescribed in the last 3 months

Exclusion Criteria

  • •participation in any formal substance abuse treatment programs in the last 30 days (excluding 12-step or self-help groups)
  • •terminal illness

Arms & Interventions

1

Experimental

Brief intervention using motivational interviewing. One in-person session (30-45 minutes) with a brief phone follow-up one week later.

Intervention: Brief intervention using motivational interviewing (Behavioral)

2

No Intervention

Enhanced care as usual.

Outcomes

Primary Outcomes

Enrollment in formal substance abuse treatment

Time Frame: baseline up to 2 years post-intervention

Enrollment in formal substance abuse treatment will be measured as an admission to chemical dependency treatment as recorded in the Washington State TARGET database.

Use of illicit drugs in the past 30 days

Time Frame: baseline, 3, 6, 9, and 12 months

Use of illicit drugs in the past 30 days will be measured by self-reported days of use in the past 30 days and validated by urine toxicological screen.

Medical, legal, employment, social, and psychiatric outcomes

Time Frame: baseline, 3, 6, 9, and 12 months

Medical, legal, employment, social, and psychiatric outcomes will be measured by composite scores on the Addiction Severity Index (ASI) Lite.

Secondary Outcomes

  • Public health outcomes(baseline up to 2 years post-intervention)
  • Cost of the intervention(baseline up to 2 years post-intervention)
  • Incremental cost-effectiveness(baseline up to 2 years post-intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Peter Roy-Byrne

Professor

University of Washington

Study Sites (1)

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