Brief Intervention in Primary Care for Problem Drug Use and Abuse

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT00877331

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

868

Enrollment

Location

Arms

Duration (Months)

13.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Substance-Related Disorders	Behavioral: Brief intervention using motivational interviewing	N/A

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:

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.
To test whether fidelity to the BI model or lower severity of drug use is associated with better outcomes.
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.
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

Actual Enrollment :

868 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Brief Intervention in Primary Care for Problem Drug Use and Abuse

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Use of illicit drugs in the past 30 days [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.
Enrollment in formal substance abuse treatment [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.
Medical, legal, employment, social, and psychiatric outcomes [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 Outcome Measures

Public health outcomes [baseline up to 2 years post-intervention]
Public health outcomes will be measured by administrative data sources (emergency room visits, hospitalizations, hospital days, HIV risk behavior, arrests, and death).
Cost of the intervention [baseline up to 2 years post-intervention]
Cost of the intervention will be measured using methods previously employed in the COMBINE study.
Incremental cost-effectiveness [baseline up to 2 years post-intervention]
Incremental cost-effectiveness will be measured from the payer perspective based on health care service use and drug use frequency.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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