CClinicalTrials.gg
CompletedNCT00877331Updated Oct 20, 2014

Brief Intervention in Primary Care for Problem Drug Use and Abuse

An interventional study of Brief intervention using motivational interviewing in Substance-Related Disorders, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-20.

Sponsored by University of Washington · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
868
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Substance-Related Disorders

Keywords

  • Drug Abuse
  • Drug Addiction
  • Drug Dependence
  • Drug Usage
  • Drug Use Disorders
  • Substance Abuse
  • Substance Addiction
  • Substance Dependence
  • Substance Use Disorders
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 868 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • participation in any formal substance abuse treatment programs in the last 30 days (excluding 12-step or self-help groups)
  • terminal illness
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
868 participants (actual)

Study arms

  • Experimental
    1

    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

  • No intervention
    2

    Enhanced care as usual.

Interventions

  • BehavioralBrief 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

    Time frame: baseline up to 2 years post-intervention

  3. 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.

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

Secondary outcomes

  1. Public health outcomes

    Public health outcomes will be measured by administrative data sources (emergency room visits, hospitalizations, hospital days, HIV risk behavior, arrests, and death).

    Time frame: baseline up to 2 years post-intervention

  2. Cost of the intervention

    Cost of the intervention will be measured using methods previously employed in the COMBINE study.

    Time frame: baseline up to 2 years post-intervention

  3. Incremental cost-effectiveness

    Incremental cost-effectiveness will be measured from the payer perspective based on health care service use and drug use frequency.

    Time frame: baseline up to 2 years post-intervention

07

Study locations

1 site
  • Harborview Medical Center
    Seattle, Washington 98104, United States
08

References and documents

Publications

  • 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. PubMed 23237456 ↗
  • 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. PubMed 25096689 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00877331
Lead sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Peter Roy-Byrne (Professor, University of Washington) — Principal investigator
First posted
Apr 7, 2009
Start date
Apr 2009
Primary completion
Oct 2013
Completion
Sep 2014
Last update
Oct 20, 2014

Study contacts

Peter P Roy-Byrne, MD
principal investigator · University of Washington
Kristin Bumgardner, BS
study director · University of Washington
Antoinette Krupski, PhD
study chair · University of Washington
Richard Ries, MD
study chair · University of Washington
Chris Dunn, PhD
study chair · University of Washington
Dennis Donovan, PhD
study chair · University of Washington
Jutta M. Joesch, PhD
study chair · University of Washington
Gary A. Zarkin, PhD
study chair · RTI International

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion