- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01683227
Screening, Brief Intervention, and Referral to Treatment for Drug Use (SBIRT)
Screening and Brief Intervention for Latino and Non-Latino White Drug Users
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive, integrated public health approach to identify and deliver a spectrum of early detection and intervention services for substance use in general medical care settings. These settings, such as emergency department visits, offer a potential "teachable moment" because patients may have perceptions of vulnerability about their health, and therefore be particularly receptive to screening and counseling. There is mounting scientific evidence suggesting SBIRT is effective in reducing alcohol use at varying levels of severity in a myriad of health care settings including primary care, emergency departments, and trauma centers. Although the SBIRT approach has shown promise for alcohol, relatively little is known about its effectiveness for adult illicit drug use specifically.
This will be among the first studies to rigorously test the SBIRT approach for drug use. It will evaluate the effectiveness of SBIRT for drug use and related factors for 700 multi-ethnic ED patients using a two-group randomized repeated-measures design in which biologically-validated drug use abstinence and related outcomes of an intervention group are compared to those of an attention-placebo control group. Over a 14-month period, bilingual/bicultural Health Educators recruited participants who reported past 30-day illicit drug use in excess of risky alcohol use from the waiting areas of two large hospital's ED and trauma units. Following consent procedures and standardized baseline assessments, Health Educators randomly assigned participants to one of the two conditions. The intervention group received "Life Shift," an SBIRT drug use intervention matched to the participant's drug use risk level. The control group received the same type and quantity of intervention in an unrelated area-Driving and Traffic Safety ("Shift Gears" program), also matched to their driving/traffic risk level. A 6-month face-to-face follow-up visit by trained measurement technicians blind to the participant's assigned condition collected standardized self-report past 30-day drug use measures (ASI-Lite)and hair samples for validating self-reported abstinence. Additional outcome variables are changes in the frequency of drug use, functional status measures (i.e., medical problems, psychiatric problems, and alcohol use), and health care utilization.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92103
- Scripps Mercy Emergency Department and Trauma Unit
-
San Diego, California, United States, 92103
- UCSD Emergency Department and Trauma Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 or over
- speak English or Spanish
- competent to give consent and interact
- drug use risk higher than alcohol use risk
Exclusion Criteria:
- under 18
- non english or spanish speaker
- no telephone where one can be reached
- too injured/sick to participate
- alcohol use risk higher than drug use risk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Screening/motivational drug intervention
Screening and brief intervention counseling matched to patient's risk level delivered in the ER
|
Screening and brief motivational intervention delivered in the ER to reduce drug use
Other Names:
|
|
Placebo Comparator: Motivational placebo intervention
Screening and brief intervention for driving and traffic safety
|
Screening and brief motivational intervention delivered in the ER to reduce driving and traffic risk
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
past 30 day drug use abstinence
Time Frame: 6 months post intervention
|
Based on the addiction severity index-Lite
|
6 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of drug use
Time Frame: 6 months post intervention
|
Based on composite score from the Addiction Severity Index-Lite
|
6 months post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan I Woodruff, PhD, San Diego State University, School of Social Work
Publications and helpful links
General Publications
- Woodruff SI, Clapp JD, Eisenberg K, McCabe C, Hohman M, Shillington AM, Sise CB, Castillo EM, Chan TC, Sise MJ, Gareri J. Randomized clinical trial of the effects of screening and brief intervention for illicit drug use: the Life Shift/Shift Gears study. Addict Sci Clin Pract. 2014 May 22;9(1):8. doi: 10.1186/1940-0640-9-8.
- Eisenberg K, Woodruff SI. Randomized controlled trial to evaluate screening and brief intervention for drug-using multiethnic emergency and trauma department patients. Addict Sci Clin Pract. 2013 Apr 8;8(1):8. doi: 10.1186/1940-0640-8-8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1RC1DA028031-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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