<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/NCT01683643</url>
  </required_header>
  <id_info>
    <org_study_id>R01DA031879</org_study_id>
    <nct_id>NCT01683643</nct_id>
  </id_info>
  <brief_title>Screening, Brief Intervention, and Referral to Treatment for Offenders</brief_title>
  <acronym>SBIRT</acronym>
  <official_title>Screening, Brief Intervention, and Referral to Treatment for Offenders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine whether SBIRT is an effective intervention with&#xD;
      inmates and to estimate the costs of providing SBIRT to this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based&#xD;
      practice that has been found to be effective in reducing alcohol and illicit drug use, mainly&#xD;
      among persons recruited in medical centers, primary care offices, emergency rooms, and&#xD;
      colleges and universities. But SBIRT has the potential to be applicable to other populations&#xD;
      that have, or that are at risk for, substance use problems. In particular, offenders have&#xD;
      high prevalence of drug and alcohol use at varying levels of severity and often do not&#xD;
      receive adequate intervention, either because of limited availability of programs, low&#xD;
      motivation, or lack of awareness of the consequences of their substance use.&#xD;
&#xD;
      The scientific aims of the study are:&#xD;
&#xD;
        1. Assess the effectiveness of SBIRT with offenders in terms of participation in brief&#xD;
           intervention (if so indicated) and enrollment in treatment (if so indicated).&#xD;
&#xD;
        2. Assess the effectiveness of SBIRT with offenders in terms of drug use, criminal&#xD;
           activity, and criminal justice involvement at 12 months following baseline.&#xD;
&#xD;
        3. Determine whether there are differences in acceptability, participation, and outcomes&#xD;
           between men and women.&#xD;
&#xD;
        4. Determine the cost of providing the SBIRT intervention with this population.&#xD;
&#xD;
      The clinical aims of the study are:&#xD;
&#xD;
        1. To complement the use of SBIRT within Los Angeles County's substance abuse treatment&#xD;
           system.&#xD;
&#xD;
        2. To expand prevention and treatment options for offenders with substance abuse problems.&#xD;
&#xD;
      To our knowledge, this would be the first rigorous test of SBIRT with an offender population.&#xD;
&#xD;
      We will recruit inmates at two Los Angeles County Sheriff jail facilities, one for men and&#xD;
      one for women (25% of total sample), and randomly assign them to the treatment (SBIRT) group&#xD;
      (N =400) or to the control (no intervention) group (N = 400). Baseline demographic data will&#xD;
      be collected. Subjects in both groups will be screened for substance use risk using The&#xD;
      Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World&#xD;
      Health Organization. Control subjects will receive only their risk score and informational&#xD;
      materials regarding the health risks of substance use. Experimental subjects, in addition to&#xD;
      their risk score and informational materials, will also receive a brief intervention and a&#xD;
      referral to treatment appropriate to their risk score from trained health educators. The&#xD;
      health educators will be provided by Homeless Health Care, Los Angeles. Twelve months after&#xD;
      study admission, all study participants will be contacted for a follow-up interview. We will&#xD;
      obtain records-based data on arrests and jail incarceration over the follow-up period from&#xD;
      the Sheriff's Department and the California Department of Justice. We will also collect&#xD;
      subject participation in publicly-funded treatment from the Substance Abuse Prevention and&#xD;
      Control Division of the Los Angeles County Department of Health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">March 31, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A reduction in the use of drugs and alcohol</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participation in treatment</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rearrest and incarceration</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A reduction in HIV risk behaviors</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The cost benefit of SBIRT for offenders</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Substance Use</condition>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>SBIRT Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baseline demographic data will be collected. Subjects will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Experimental subjects, in addition to their risk score and informational materials, will also receive a brief intervention and a referral to treatment appropriate to their risk score from trained health educators. The health educators will be provided by Homeless Health Care, Los Angeles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Baseline demographic data will be collected. Subjects will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Control subjects will receive only their risk score and informational materials regarding the health risks of substance use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SBIRT</intervention_name>
    <description>Screening, brief intervention, and referral to treatment.</description>
    <arm_group_label>SBIRT Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>Control subjects will receive only their risk score and informational materials regarding the health risks of substance use.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The sample for the study will be drawn from an offender population who are within 2-3&#xD;
             weeks of their release from MCJ or CRDF in Los Angeles County. In addition, subjects&#xD;
             must be:&#xD;
&#xD;
               -  At least 18 years of age&#xD;
&#xD;
               -  English or Spanish speaking&#xD;
&#xD;
               -  Not subject to extended jail or prison sentence&#xD;
&#xD;
               -  Able to provide informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Study exclusion criteria:&#xD;
&#xD;
               -  Inability to provide informed consent to study participation because of cognitive&#xD;
                  impairment.&#xD;
&#xD;
               -  Inability to communicate in either English or Spanish&#xD;
&#xD;
               -  Refusal to complete Locator form for follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Prendergast, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA Integrated Substance Abuse Programs</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jerry Cartier, M.A.</last_name>
    <role>Study Director</role>
    <affiliation>UCLA Integrated Substance Abuse Programs</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>May 9, 2017</last_update_submitted>
  <last_update_submitted_qc>May 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Michael Prendergast</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT01683643
org study id: R01DA031879
nct id: NCT01683643
lead sponsor: 
has dmc: Yes
The purpose of the study is to determine whether SBIRT is an effective intervention with
      inmates and to estimate the costs of providing SBIRT to this population.
Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based
      practice that has been found to be effective in reducing alcohol and illicit drug use, mainly
      among persons recruited in medical centers, primary care offices, emergency rooms, and
      colleges and universities. But SBIRT has the potential to be applicable to other populations
      that have, or that are at risk for, substance use problems. In particular, offenders have
      high prevalence of drug and alcohol use at varying levels of severity and often do not
      receive adequate intervention, either because of limited availability of programs, low
      motivation, or lack of awareness of the consequences of their substance use.

      The scientific aims of the study are:

        1. Assess the effectiveness of SBIRT with offenders in terms of participation in brief
           intervention (if so indicated) and enrollment in treatment (if so indicated).

        2. Assess the effectiveness of SBIRT with offenders in terms of drug use, criminal
           activity, and criminal justice involvement at 12 months following baseline.

        3. Determine whether there are differences in acceptability, participation, and outcomes
           between men and women.

        4. Determine the cost of providing the SBIRT intervention with this population.

      The clinical aims of the study are:

        1. To complement the use of SBIRT within Los Angeles County's substance abuse treatment
           system.

        2. To expand prevention and treatment options for offenders with substance abuse problems.

      To our knowledge, this would be the first rigorous test of SBIRT with an offender population.

      We will recruit inmates at two Los Angeles County Sheriff jail facilities, one for men and
      one for women (25% of total sample), and randomly assign them to the treatment (SBIRT) group
      (N =400) or to the control (no intervention) group (N = 400). Baseline demographic data will
      be collected. Subjects in both groups will be screened for substance use risk using The
      Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World
      Health Organization. Control subjects will receive only their risk score and informational
      materials regarding the health risks of substance use. Experimental subjects, in addition to
      their risk score and informational materials, will also receive a brief intervention and a
      referral to treatment appropriate to their risk score from trained health educators. The
      health educators will be provided by Homeless Health Care, Los Angeles. Twelve months after
      study admission, all study participants will be contacted for a follow-up interview. We will
      obtain records-based data on arrests and jail incarceration over the follow-up period from
      the Sheriff's Department and the California Department of Justice. We will also collect
      subject participation in publicly-funded treatment from the Substance Abuse Prevention and
      Control Division of the Los Angeles County Department of Health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: A reduction in the use of drugs and alcohol
time frame: 12 months
measure: Participation in treatment
time frame: 12 months
measure: Rearrest and incarceration
time frame: 12 months
measure: Quality of life
time frame: 12 months
measure: A reduction in HIV risk behaviors
time frame: 12 months
measure: The cost benefit of SBIRT for offenders
time frame: 12 months
arm group label: SBIRT Group
arm group type: Experimental
description: Baseline demographic data will be collected. Subjects will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Experimental subjects, in addition to their risk score and informational materials, will also receive a brief intervention and a referral to treatment appropriate to their risk score from trained health educators. The health educators will be provided by Homeless Health Care, Los Angeles.
arm group label: Control Group
arm group type: Active Comparator
description: Baseline demographic data will be collected. Subjects will be screened for substance use risk using The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) developed by the World Health Organization. Control subjects will receive only their risk score and informational materials regarding the health risks of substance use.
intervention type: Behavioral
intervention name: SBIRT
description: Screening, brief intervention, and referral to treatment.
arm group label: SBIRT Group
intervention type: Behavioral
intervention name: Control Group
description: Control subjects will receive only their risk score and informational materials regarding the health risks of substance use.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Michael Prendergast, Ph.D
role: Principal Investigator
affiliation: UCLA Integrated Substance Abuse Programs
last name: Jerry Cartier, M.A.
role: Study Director
affiliation: UCLA Integrated Substance Abuse Programs
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Michael Prendergast
investigator title: Principal Investigator
mesh term: Substance-Related Disorders