Brief Intervention in Primary Care for Problem Drug Use and Abuse
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|ClinicalTrials.gov Identifier: NCT00877331|
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : October 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Substance-Related Disorders||Behavioral: Brief intervention using motivational interviewing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||868 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Brief Intervention in Primary Care for Problem Drug Use and Abuse|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||September 2014|
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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877331
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Peter P Roy-Byrne, MD||University of Washington|
|Study Director:||Kristin Bumgardner, BS||University of Washington|
|Study Chair:||Antoinette Krupski, PhD||University of Washington|
|Study Chair:||Richard Ries, MD||University of Washington|
|Study Chair:||Chris Dunn, PhD||University of Washington|
|Study Chair:||Dennis Donovan, PhD||University of Washington|
|Study Chair:||Jutta M. Joesch, PhD||University of Washington|
|Study Chair:||Gary A. Zarkin, PhD||RTI International|