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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Susan I. Woodruff, San Diego State University
ClinicalTrials.gov Identifier:
NCT01683227
First received: September 7, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Drug Abuse
Behavioral: Screening/motivational drug intervention
Behavioral: Motivational placebo intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Screening and Brief Intervention for Latino and Non-Latino White Drug Users

Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • past 30 day drug use abstinence [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    Based on the addiction severity index-Lite


Secondary Outcome Measures:
  • Frequency of drug use [ Time Frame: 6 months post intervention ] [ Designated as safety issue: No ]
    Based on composite score from the Addiction Severity Index-Lite


Enrollment: 700
Study Start Date: April 2010
Estimated Study Completion Date: October 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Screening/motivational drug intervention
Screening and brief intervention counseling matched to patient's risk level delivered in the ER
Behavioral: Screening/motivational drug intervention
Screening and brief motivational intervention delivered in the ER to reduce drug use
Other Name: SBIRT
Placebo Comparator: Motivational placebo intervention
Screening and brief intervention for driving and traffic safety
Behavioral: Motivational placebo intervention
Screening and brief motivational intervention delivered in the ER to reduce driving and traffic risk

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683227

Locations
United States, California
UCSD Emergency Department and Trauma Unit
San Diego, California, United States, 92103
Scripps Mercy Emergency Department and Trauma Unit
San Diego, California, United States, 92103
Sponsors and Collaborators
San Diego State University
Investigators
Principal Investigator: Susan I Woodruff, PhD San Diego State University, School of Social Work
  More Information

No publications provided by San Diego State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan I. Woodruff, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT01683227     History of Changes
Other Study ID Numbers: 1RC1DA028031-01
Study First Received: September 7, 2012
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by San Diego State University:
drug use; emergency department; brief intervention

ClinicalTrials.gov processed this record on October 19, 2014