Brief Intervention in Primary Care for Problem Drug Use and Abuse

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter Roy-Byrne, University of Washington
ClinicalTrials.gov Identifier:
NCT00877331
First received: April 6, 2009
Last updated: May 19, 2014
Last verified: May 2014
  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:
  • Use of illicit drugs in the past 30 days [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline up to 2 years post-intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline up to 2 years post-intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline up to 2 years post-intervention ] [ Designated as safety issue: No ]
    Cost of the intervention will be measured using methods previously employed in the COMBINE study.

  • Incremental cost-effectiveness [ Time Frame: baseline up to 2 years post-intervention ] [ Designated as safety issue: No ]
    Incremental cost-effectiveness will be measured from the payer perspective based on health care service use and drug use frequency.


Estimated Enrollment: 1000
Study Start Date: April 2009
Estimated Study Completion Date: September 2014
Primary Completion Date: October 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 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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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):
Responsible Party: Peter Roy-Byrne, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00877331     History of Changes
Other Study ID Numbers: 34892-C, R01DA026014
Study First Received: April 6, 2009
Last Updated: May 19, 2014
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 July 22, 2014