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Completed

NCT Number: NCT00877331

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.

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Key information

Conditions

Substance-related Disorders Chemically-Induced Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief intervention using motivational interviewing

Behavioral

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.

Primary outcomes

  1. Use of illicit drugs in the past 30 days

    Time frame: 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.

  2. Enrollment in formal substance abuse treatment

    Time frame: 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.

  3. Medical, legal, employment, social, and psychiatric outcomes

    Time frame: 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 outcomes

  1. Public health outcomes

    Time frame: 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).

  2. Cost of the intervention

    Time frame: baseline up to 2 years post-intervention

    Cost of the intervention will be measured using methods previously employed in the COMBINE study.

  3. Incremental cost-effectiveness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Apr 7, 2009
Registry last updated
Oct 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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