<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01683227</url>
  </required_header>
  <id_info>
    <org_study_id>1RC1DA028031-01</org_study_id>
    <nct_id>NCT01683227</nct_id>
  </id_info>
  <brief_title>Screening, Brief Intervention, and Referral to Treatment for Drug Use</brief_title>
  <acronym>SBIRT</acronym>
  <official_title>Screening and Brief Intervention for Latino and Non-Latino White Drug Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Diego State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Screening, Brief Intervention, and Referral to Treatment (SBIRT) is a comprehensive,&#xD;
      integrated public health approach to identify and deliver a spectrum of early detection and&#xD;
      intervention services for substance use in general medical care settings. These settings,&#xD;
      such as emergency department visits, offer a potential &quot;teachable moment&quot; because patients&#xD;
      may have perceptions of vulnerability about their health, and therefore be particularly&#xD;
      receptive to screening and counseling. There is mounting scientific evidence suggesting SBIRT&#xD;
      is effective in reducing alcohol use at varying levels of severity in a myriad of health care&#xD;
      settings including primary care, emergency departments, and trauma centers. Although the&#xD;
      SBIRT approach has shown promise for alcohol, relatively little is known about its&#xD;
      effectiveness for adult illicit drug use specifically.&#xD;
&#xD;
      This will be among the first studies to rigorously test the SBIRT approach for drug use. It&#xD;
      will evaluate the effectiveness of SBIRT for drug use and related factors for 700&#xD;
      multi-ethnic ED patients using a two-group randomized repeated-measures design in which&#xD;
      biologically-validated drug use abstinence and related outcomes of an intervention group are&#xD;
      compared to those of an attention-placebo control group. Over a 14-month period,&#xD;
      bilingual/bicultural Health Educators recruited participants who reported past 30-day illicit&#xD;
      drug use in excess of risky alcohol use from the waiting areas of two large hospital's ED and&#xD;
      trauma units. Following consent procedures and standardized baseline assessments, Health&#xD;
      Educators randomly assigned participants to one of the two conditions. The intervention group&#xD;
      received &quot;Life Shift,&quot; an SBIRT drug use intervention matched to the participant's drug use&#xD;
      risk level. The control group received the same type and quantity of intervention in an&#xD;
      unrelated area-Driving and Traffic Safety (&quot;Shift Gears&quot; program), also matched to their&#xD;
      driving/traffic risk level. A 6-month face-to-face follow-up visit by trained measurement&#xD;
      technicians blind to the participant's assigned condition collected standardized self-report&#xD;
      past 30-day drug use measures (ASI-Lite)and hair samples for validating self-reported&#xD;
      abstinence. Additional outcome variables are changes in the frequency of drug use, functional&#xD;
      status measures (i.e., medical problems, psychiatric problems, and alcohol use), and health&#xD;
      care utilization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">June 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>past 30 day drug use abstinence</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>Based on the addiction severity index-Lite</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of drug use</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>Based on composite score from the Addiction Severity Index-Lite</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">700</enrollment>
  <condition>Drug Abuse</condition>
  <arm_group>
    <arm_group_label>Screening/motivational drug intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Screening and brief intervention counseling matched to patient's risk level delivered in the ER</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Motivational placebo intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Screening and brief intervention for driving and traffic safety</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Screening/motivational drug intervention</intervention_name>
    <description>Screening and brief motivational intervention delivered in the ER to reduce drug use</description>
    <arm_group_label>Screening/motivational drug intervention</arm_group_label>
    <other_name>SBIRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational placebo intervention</intervention_name>
    <description>Screening and brief motivational intervention delivered in the ER to reduce driving and traffic risk</description>
    <arm_group_label>Motivational placebo intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 or over&#xD;
&#xD;
          -  speak English or Spanish&#xD;
&#xD;
          -  competent to give consent and interact&#xD;
&#xD;
          -  drug use risk higher than alcohol use risk&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18&#xD;
&#xD;
          -  non english or spanish speaker&#xD;
&#xD;
          -  no telephone where one can be reached&#xD;
&#xD;
          -  too injured/sick to participate&#xD;
&#xD;
          -  alcohol use risk higher than drug use risk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan I Woodruff, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego State University, School of Social Work</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scripps Mercy Emergency Department and Trauma Unit</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD Emergency Department and Trauma Unit</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>April 18, 2016</last_update_submitted>
  <last_update_submitted_qc>April 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego State University</investigator_affiliation>
    <investigator_full_name>Susan I. Woodruff</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>drug use; emergency department; brief intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01683227
org study id: 1RC1DA028031-01
nct id: NCT01683227
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: past 30 day drug use abstinence
time frame: 6 months post intervention
description: Based on the addiction severity index-Lite
measure: Frequency of drug use
time frame: 6 months post intervention
description: Based on composite score from the Addiction Severity Index-Lite
arm group label: Screening/motivational drug intervention
arm group type: Experimental
description: Screening and brief intervention counseling matched to patient's risk level delivered in the ER
arm group label: Motivational placebo intervention
arm group type: Placebo Comparator
description: Screening and brief intervention for driving and traffic safety
intervention type: Behavioral
intervention name: Screening/motivational drug intervention
description: Screening and brief motivational intervention delivered in the ER to reduce drug use
arm group label: Screening/motivational drug intervention
other name: SBIRT
intervention type: Behavioral
intervention name: Motivational placebo intervention
description: Screening and brief motivational intervention delivered in the ER to reduce driving and traffic risk
arm group label: Motivational placebo intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan I Woodruff, PhD
role: Principal Investigator
affiliation: San Diego State University, School of Social Work
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: San Diego State University
investigator full name: Susan I. Woodruff
investigator title: Professor
mesh term: Substance-Related Disorders