Brief Intervention in Primary Care for Problem Drug Use and Abuse - Full Text View

Purpose

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	Intervention
Substance-Related Disorders	Behavioral: Brief Intervention using motivational interviewing

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Brief Intervention in Primary Care for Problem Drug Use and Abuse

Further study details as provided by University of Washington:

Primary Outcome Measures:

Effectiveness of the intervention to reduce use of illicit drugs 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effectiveness of the intervention to increase attendance in drug abuse treatment programs will be measured by self-report and by administrative data review. [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
Effectiveness of the intervention to reduce use of illicit drugs in individuals with milder hazardous use will be measured by self-reported scores on assessments. [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
Testing whether intervention fidelity is associated with better outcomes will be measured by scoring interventionists' proficiency. [ Time Frame: one-time intervention at baseline ] [ Designated as safety issue: No ]
Effectiveness of the intervention to impact 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 through 2 years post-intervention ] [ Designated as safety issue: No ]
Effectiveness of the study to estimate costs of the intervention compared to the control arm will be measured by administrative data. [ Time Frame: baseline through 2 years post-intervention ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	April 2009
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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 are:

To examine whether BI is effective at improving outcomes 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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

at least 18 years old
receive medical care at one of the four participating primary care clinics at Harborview Medical Center (Adult Medicine Clinic, Family Medicine Clinic, Women's Clinic, and Pioneer Square Clinic)
will maintain care at Harborview Medical Center 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877331

Locations

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

Sponsors and Collaborators

University of Washington

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Peter P Roy-Byrne, MD	University of Washington
Study Director:	Dennis M Donovan, PhD	University of Washington
Study Director:	Christopher W Dunn, PhD	University of Washington
Study Director:	Jutta M Joesch, PhD	University of Washington
Study Director:	Antoinette Krupski, PhD	University of Washington
Study Director:	Richard K Ries, MD	University of Washington
Study Director:	Jeanne Sears, PhD	University of Washington
Study Director:	Sharon Estee, PhD	WA Dept of Social & Health Services
Study Director:	Gary Zarkin, PhD	RTI International

More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	University of Washington
ClinicalTrials.gov Identifier:	NCT00877331 History of Changes
Other Study ID Numbers:	DESPR DA026014, R01DA026014
Study First Received:	April 6, 2009
Last Updated:	November 6, 2012
Health Authority:	United States: Federal Government

Keywords provided by University of Washington:

Drug Abuse
Drug Addiction
Drug Dependence
Drug Usage
Drug Use Disorders

Substance Abuse
Substance Addiction
Substance Dependence
Substance Use Disorders

Additional relevant MeSH terms:

Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013