NCT00877331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
868

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

4.5 years

First QC Date

April 6, 2009

Last Update Submit

October 17, 2014

Conditions

Substance-Related Disorders

Keywords

Drug AbuseDrug AddictionDrug DependenceDrug UsageDrug Use DisordersSubstance AbuseSubstance AddictionSubstance DependenceSubstance Use Disorders

Outcome Measures

Primary Outcomes (3)

  • Use of illicit drugs in the past 30 days

    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.

    baseline, 3, 6, 9, and 12 months

  • Enrollment in formal substance abuse treatment

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

    baseline up to 2 years post-intervention

  • Medical, legal, employment, social, and psychiatric outcomes

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

    baseline, 3, 6, 9, and 12 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Brief intervention using motivational interviewing

2

NO INTERVENTION

Enhanced care as usual.

Interventions

Brief intervention using motivational interviewingBEHAVIORAL

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • 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.

    PMID: 23237456BACKGROUND

  • 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.

    PMID: 25096689RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Peter P Roy-Byrne, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Kristin Bumgardner, BS

    University of Washington

    STUDY DIRECTOR

  • Antoinette Krupski, PhD

    University of Washington

    STUDY CHAIR

  • Richard Ries, MD

    University of Washington

    STUDY CHAIR

  • Chris Dunn, PhD

    University of Washington

    STUDY CHAIR

  • Dennis Donovan, PhD

    University of Washington

    STUDY CHAIR

  • Jutta M. Joesch, PhD

    University of Washington

    STUDY CHAIR

  • Gary A. Zarkin, PhD

    RTI International

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 7, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2013

Study Completion

September 1, 2014

Last Updated

October 20, 2014

Record last verified: 2014-10

Locations

US(1)