Brief Intervention in Primary Care for Problem Drug Use and Abuse

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders
• Intervention / Treatment: Behavioral: Brief intervention using motivational interviewing

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 Type: Interventional
• Enrollment (Actual): 868
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
No Intervention: 2; Enhanced care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	baseline up to 2 years post-intervention
Cost of the intervention	Cost of the intervention will be measured using methods previously employed in the COMBINE study.	baseline up to 2 years post-intervention
Incremental cost-effectiveness	Incremental cost-effectiveness will be measured from the payer perspective based on health care service use and drug use frequency.	baseline up to 2 years post-intervention

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Peter P Roy-Byrne, MD, University of Washington; Study Director: Kristin Bumgardner, BS, University of Washington; Study Chair: 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

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 6, 2009
• First Submitted That Met QC Criteria: April 6, 2009
• First Posted (Estimate): April 7, 2009

Study Record Updates

• Last Update Posted (Estimate): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Drug Abuse; Substance Abuse; Substance Use Disorders; Drug Dependence; Substance Dependence; Drug Use Disorders; Substance Addiction; Drug Addiction; Drug Usage
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 34892-C; R01DA026014 (U.S. NIH Grant/Contract)