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: October 21, 2013
Last verified: October 2013

April 6, 2009
October 21, 2013
April 2009
October 2013   (final data collection date for primary outcome measure)
  • 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.
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 ]
Complete list of historical versions of study NCT00877331 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Brief Intervention in Primary Care for Problem Drug Use and Abuse
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Substance-Related Disorders
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.
  • Experimental: 1
    Brief intervention using motivational interviewing. One in-person session (30-45 minutes) with a brief phone follow-up one week later.
    Intervention: Behavioral: Brief Intervention using motivational interviewing
  • No Intervention: 2
    Enhanced care as usual.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
September 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00877331
34892-C, R01DA026014
Yes
Peter Roy-Byrne, University of Washington
University of Washington
National Institute on Drug Abuse (NIDA)
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
University of Washington
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP