Screening, Brief Intervention, and Referral to Treatment for Drug Use (SBIRT)

Tracking Information
First Submitted Date ICMJE	September 7, 2012
First Posted Date ICMJE	September 11, 2012
Last Update Posted Date	April 19, 2016
Study Start Date ICMJE	April 2010
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 7, 2012)	past 30 day drug use abstinence [ Time Frame: 6 months post intervention ]; Based on the addiction severity index-Lite
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01683227 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 7, 2012)	Frequency of drug use [ Time Frame: 6 months post intervention ]; Based on composite score from the Addiction Severity Index-Lite
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Screening, Brief Intervention, and Referral to Treatment for Drug Use
Official Title ICMJE	Screening and Brief Intervention for Latino and Non-Latino White Drug Users
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Drug Abuse
Intervention ICMJE	Behavioral: Screening/motivational drug intervention Screening and brief motivational intervention delivered in the ER to reduce drug use Other Name: SBIRT; Behavioral: Motivational placebo intervention Screening and brief motivational intervention delivered in the ER to reduce driving and traffic risk
Study Arms	Experimental: Screening/motivational drug intervention Screening and brief intervention counseling matched to patient's risk level delivered in the ER Intervention: Behavioral: Screening/motivational drug intervention; Placebo Comparator: Motivational placebo intervention Screening and brief intervention for driving and traffic safety Intervention: Behavioral: Motivational placebo intervention
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;9:8. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 7, 2012)	700
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2012
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 100 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01683227
Other Study ID Numbers ICMJE	1RC1DA028031-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Susan I. Woodruff, San Diego State University
Study Sponsor ICMJE	San Diego State University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Susan I Woodruff, PhD San Diego State University, School of Social Work
PRS Account	San Diego State University
Verification Date	April 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP