Clinical trial NCT01683227: Screening, Brief Intervention, and Referral to Treatment for Drug Use
Official title: Screening and Brief Intervention for Latino and Non-Latino White Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Abuse
Keywords: drug use; emergency department; brief intervention
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: past 30 day drug use abstinence
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Frequency of drug use
timeFrame: 6 months post intervention
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Mercy Emergency Department and Trauma Unit
state: California
city: San Diego
country: United States
facility: UCSD Emergency Department and Trauma Unit
state: California
Study officials:
affiliation: San Diego State University, School of Social Work
name: Susan I Woodruff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.