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Clinical Trials/NCT01683227
NCT01683227CompletedNot Applicable

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

San Diego State University2 sites in 1 country700 target enrollmentStarted: April 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
700
Locations
2
Primary Endpoint
past 30 day drug use abstinence

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • •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

Arms & Interventions

Screening/motivational drug intervention

Experimental

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

Intervention: Screening/motivational drug intervention (Behavioral)

Motivational placebo intervention

Placebo Comparator

Screening and brief intervention for driving and traffic safety

Intervention: Motivational placebo intervention (Behavioral)

Outcomes

Primary Outcomes

past 30 day drug use abstinence

Time Frame: 6 months post intervention

Based on the addiction severity index-Lite

Secondary Outcomes

  • Frequency of drug use(6 months post intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Susan I. Woodruff

Professor

San Diego State University

Study Sites (2)

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