Brief Intervention in Primary Care for Problem Drug Use and Abuse

NCT ID: NCT00877331

Last Updated: 2014-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 868 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2014-09-30

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.

Conditions

Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Brief intervention using motivational interviewing

Intervention Type: BEHAVIORAL

One brief, in-person motivational interviewing session (30-45 minutes) in conjunction with the medical appointment. Plus one brief follow-up phone call one week later.

2

Enhanced care as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brief intervention using motivational interviewing

One brief, in-person motivational interviewing session (30-45 minutes) in conjunction with the medical appointment. Plus one brief follow-up phone call one week later.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Peter Roy-Byrne

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter P Roy-Byrne, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Kristin Bumgardner, BS

Role: STUDY_DIRECTOR

University of Washington

Antoinette Krupski, PhD

Role: STUDY_CHAIR

University of Washington

Richard Ries, MD

Role: STUDY_CHAIR

University of Washington

Chris Dunn, PhD

Role: STUDY_CHAIR

University of Washington

Dennis Donovan, PhD

Role: STUDY_CHAIR

University of Washington

Jutta M. Joesch, PhD

Role: STUDY_CHAIR

University of Washington

Gary A. Zarkin, PhD

Role: STUDY_CHAIR

RTI International

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

Krupski A, Joesch JM, Dunn C, Donovan D, Bumgardner K, Lord SP, Ries R, Roy-Byrne P. Testing the effects of brief intervention in primary care for problem drug use in a randomized controlled trial: rationale, design, and methods. Addict Sci Clin Pract. 2012 Dec 14;7(1):27. doi: 10.1186/1940-0640-7-27.

Reference Type: BACKGROUND

PMID: 23237456 (View on PubMed)

Roy-Byrne P, Bumgardner K, Krupski A, Dunn C, Ries R, Donovan D, West II, Maynard C, Atkins DC, Graves MC, Joesch JM, Zarkin GA. Brief intervention for problem drug use in safety-net primary care settings: a randomized clinical trial. JAMA. 2014 Aug 6;312(5):492-501. doi: 10.1001/jama.2014.7860.

Reference Type: RESULT

PMID: 25096689 (View on PubMed)

Other Identifiers

R01DA026014

Identifier Type: NIH

Identifier Source: secondary_id

View Link

34892-C

Identifier Type: -

Identifier Source: org_study_id