Brief Intervention in Primary Care for Problem Drug Use and Abuse

Substance-Related Disorders Clinical Trial

Official title:

Brief Intervention in Primary Care for Problem Drug Use and Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877331
• Other study ID #: 34892-C
• Secondary ID: R01DA026014
• Status: Completed
• Phase: N/A
• First received: April 6, 2009
• Last updated: October 17, 2014
• Start date: April 2009
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 868
• Est. completion date: September 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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;7:27. doi: 10.1186/1940-0640-7-27. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No