Screening, Brief Intervention, and Referral to Treatment for Drug Use

Drug Abuse Clinical Trial

— SBIRT  

Official title:

Screening and Brief Intervention for Latino and Non-Latino White Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683227
• Other study ID #: 1RC1DA028031-01
• Status: Completed
• Phase: N/A
• First received: September 7, 2012
• Last updated: April 18, 2016
• Start date: April 2010
• Est. completion date: August 2012

Study information

• Verified date: April 2016
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: August 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Abuse

Intervention

Behavioral:
• Screening/motivational drug intervention
Screening and brief motivational intervention delivered in the ER to reduce drug use
• Motivational placebo intervention
Screening and brief motivational intervention delivered in the ER to reduce driving and traffic risk

Locations

Country	Name	City	State
United States	Scripps Mercy Emergency Department and Trauma Unit	San Diego	California
United States	UCSD Emergency Department and Trauma Unit	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	past 30 day drug use abstinence	Based on the addiction severity index-Lite	6 months post intervention	No
Secondary	Frequency of drug use	Based on composite score from the Addiction Severity Index-Lite	6 months post intervention	No