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

Primary Purpose

Drug Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening/motivational drug intervention
Motivational placebo intervention
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Abuse focused on measuring drug use; emergency department; brief intervention

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Scripps Mercy Emergency Department and Trauma Unit
  • UCSD Emergency Department and Trauma Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Screening/motivational drug intervention

Motivational placebo intervention

Arm Description

Screening and brief intervention counseling matched to patient's risk level delivered in the ER

Screening and brief intervention for driving and traffic safety

Outcomes

Primary Outcome Measures

past 30 day drug use abstinence
Based on the addiction severity index-Lite

Secondary Outcome Measures

Frequency of drug use
Based on composite score from the Addiction Severity Index-Lite

Full Information

First Posted
September 7, 2012
Last Updated
April 18, 2016
Sponsor
San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT01683227
Brief Title
Screening, Brief Intervention, and Referral to Treatment for Drug Use
Acronym
SBIRT
Official Title
Screening and Brief Intervention for Latino and Non-Latino White Drug Users
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
drug use; emergency department; brief intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screening/motivational drug intervention
Arm Type
Experimental
Arm Description
Screening and brief intervention counseling matched to patient's risk level delivered in the ER
Arm Title
Motivational placebo intervention
Arm Type
Placebo Comparator
Arm Description
Screening and brief intervention for driving and traffic safety
Intervention Type
Behavioral
Intervention Name(s)
Screening/motivational drug intervention
Other Intervention Name(s)
SBIRT
Intervention Description
Screening and brief motivational intervention delivered in the ER to reduce drug use
Intervention Type
Behavioral
Intervention Name(s)
Motivational placebo intervention
Intervention Description
Screening and brief motivational intervention delivered in the ER to reduce driving and traffic risk
Primary Outcome Measure Information:
Title
past 30 day drug use abstinence
Description
Based on the addiction severity index-Lite
Time Frame
6 months post intervention
Secondary Outcome Measure Information:
Title
Frequency of drug use
Description
Based on composite score from the Addiction Severity Index-Lite
Time Frame
6 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan I Woodruff, PhD
Organizational Affiliation
San Diego State University, School of Social Work
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Mercy Emergency Department and Trauma Unit
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSD Emergency Department and Trauma Unit
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24886786
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.
Results Reference
derived
PubMed Identifier
23566363
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.
Results Reference
derived

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

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