<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/NCT02222389</url>
  </required_header>
  <id_info>
    <org_study_id>13210-001</org_study_id>
    <nct_id>NCT02222389</nct_id>
  </id_info>
  <brief_title>Contingency Management for the Treatment of Co-Occurring Alcohol and Drug Misuse</brief_title>
  <official_title>P20 Research Project 1 Contingency Management for the Treatment of Co-Occurring Alcohol and Drug Misuse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington State University</source>
  <brief_summary>
    <textblock>
      Contingency management (CM) is a type of treatment used in the substance abuse field.&#xD;
      Patients' behaviors are rewarded for adherence to a treatment plan. As an approach to&#xD;
      treatment, contingency management emerged from the behavior therapy traditions in mental&#xD;
      health. By most evaluations, contingency management procedures produce one of the largest&#xD;
      effect sizes out of all mental health and educational interventions.&#xD;
&#xD;
      The purpose of this study is to perform a randomized, controlled trial to evaluate the&#xD;
      ability of a culturally-tailored contingency management (CM) intervention to increase alcohol&#xD;
      and drug abstinence among American Indian (AI) tribal members from two rural reservations in&#xD;
      the Northwest.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Actual">September 10, 2018</completion_date>
  <primary_completion_date type="Actual">September 10, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemically verified alcohol and/or drug abstinence</measure>
    <time_frame>24 weeks</time_frame>
    <description>At every study visit, urine samples will be collected and analyzed for ethyl glucuronide and drugs. This helps assess Contingency Management as a treatment for alcohol and/or drug dependence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self- reported data on alcohol and drug use</measure>
    <time_frame>24 weeks</time_frame>
    <description>Measures used for self-reported data on alcohol and drug use:&#xD;
The Alcohol and Drug Timeline Follow Back (TLFB)&#xD;
The Current Opioid Misuse Measure (COMM)&#xD;
The Addiction Severity Index, Native American Version (ASI-NAV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other substance use</measure>
    <time_frame>24 weeks</time_frame>
    <description>Amphetamine, methamphetamine, cocaine, and marijuana, will be measured by the same procedures described for urine tests of alcohol and drug metabolites.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self- reported data on health behaviors</measure>
    <time_frame>24 weeks</time_frame>
    <description>We will also collect secondary outcome data on health behaviors that frequently correlate with alcohol and drug misuse with the following measures:&#xD;
The Timeline Follow Back will be used to assess daily number of cigarettes smoked.&#xD;
Brief HIV Risk Behavior Scale&#xD;
Veteran's Rand- 12&#xD;
Self-Report Services Utilization Assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Measures used for descriptive purposes and to assess success of randomization.</measure>
    <time_frame>24 weeks</time_frame>
    <description>We will measure psychopathology with the Brief Symptom Inventory, a self-report instrument that will assess levels of anxiety, depression, impulsiveness, at baseline to characterize the psychiatric severity of the sample that has been used in previous studies of American Indians.</description>
  </other_outcome>
  <other_outcome>
    <measure>Measures used for descriptive purposes and to assess success of randomization.</measure>
    <time_frame>24 weeks</time_frame>
    <description>The Fagerström Test of Nicotine Dependence will measure the presence and severity of nicotine dependence.</description>
  </other_outcome>
  <other_outcome>
    <measure>Measures used for descriptive purposes and to assess success of randomization</measure>
    <time_frame>24 weeks</time_frame>
    <description>Interest in alcohol and drug abstinence will be assessed by the Stages of Change Readiness and Treatment Eagerness Scale.</description>
  </other_outcome>
  <other_outcome>
    <measure>Measures used for descriptive purposes and to assess success of randomization</measure>
    <time_frame>24 weeks</time_frame>
    <description>In addition, other demographic, cultural, and cigarette smoking and alcohol use measures will be administered at baseline. These measures are part of the P20 Center Core measures. These measures include the Veteran's Rand-12 (already gathered as part of this study's protocol), the Behavioral Risk Factor Surveillance System Alcohol Survey, and demographic, cultural, and smoking behaviors (Behavioral Health Cooperative, Core Measures).</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Co-Occurring Alcohol and Drug Misuse</condition>
  <arm_group>
    <arm_group_label>CM for alcohol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CM for alcohol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CM for drugs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CM for drugs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CM for both substances</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CM for both substances</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Contingent group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No CM for either substance, the Non-Contingent (NC) group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CM for Alcohol</intervention_name>
    <description>Escalating reinforcement for alcohol abstinence.&#xD;
Alcohol-negative CM Participants draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say &quot;good job!&quot; or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize.</description>
    <arm_group_label>CM for alcohol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CM for drugs</intervention_name>
    <description>Escalating reinforcement for drug abstinence.&#xD;
Drug-negative participants will be invited to draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say &quot;good job!&quot; or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize.</description>
    <arm_group_label>CM for drugs</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CM for both substances</intervention_name>
    <description>Escalating reinforcement for drug and alcohol abstinence.&#xD;
Drug- and alcohol-negative participants will be invited to draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say &quot;good job!&quot; or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize.</description>
    <arm_group_label>CM for both substances</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-Contingent group</intervention_name>
    <description>Compensation for Non-Contingent control group participants is dependent only on providing urine samples, regardless of whether the urine tests are negative for alcohol and/or drugs.</description>
    <arm_group_label>Non-Contingent group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Self-identify race as American Indian (AI)&#xD;
&#xD;
          2. Are seeking alcohol dependence and drug abuse treatment at a participating reservation&#xD;
&#xD;
          3. Are age 18 or older&#xD;
&#xD;
          4. Meet criteria of DSM-IV diagnosis of current alcohol dependence&#xD;
&#xD;
          5. Current drug misuse&#xD;
&#xD;
          6. Are not pregnant or planning to become pregnant for the duration of the study&#xD;
&#xD;
          7. Are English speaking&#xD;
&#xD;
          8. Have the ability to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have significant risk of dangerous alcohol withdrawal, defined as a history of alcohol&#xD;
             detoxification or seizure during the last 12 months AND expression of concern by the&#xD;
             patient and/or healthcare provider&#xD;
&#xD;
          2. Meet criteria for DSM-IV diagnosis of drug dependence&#xD;
&#xD;
          3. Have significant risk of dangerous drug withdrawal and/or self-reported or medically&#xD;
             documented severe withdrawal from drugs in the last 6 months&#xD;
&#xD;
          4. Have any medical or psychiatric condition, such as organic brain disorder, dementia,&#xD;
             or psychotic disorder, that the Principal Investigator determines would compromise&#xD;
             safe study participation&#xD;
&#xD;
          5. Are receiving drugs under the direction of a physician for pain management or another&#xD;
             medical condition for which drug abstinence is contraindicated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mike McDonell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington State University</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>September 15, 2018</last_update_submitted>
  <last_update_submitted_qc>September 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington State University</investigator_affiliation>
    <investigator_full_name>Michael McDonell</investigator_full_name>
    <investigator_title>Associate Director &amp; Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02222389
org study id: 13210-001
nct id: NCT02222389
lead sponsor: 
Contingency management (CM) is a type of treatment used in the substance abuse field.
      Patients' behaviors are rewarded for adherence to a treatment plan. As an approach to
      treatment, contingency management emerged from the behavior therapy traditions in mental
      health. By most evaluations, contingency management procedures produce one of the largest
      effect sizes out of all mental health and educational interventions.

      The purpose of this study is to perform a randomized, controlled trial to evaluate the
      ability of a culturally-tailored contingency management (CM) intervention to increase alcohol
      and drug abstinence among American Indian (AI) tribal members from two rural reservations in
      the Northwest.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Biochemically verified alcohol and/or drug abstinence
time frame: 24 weeks
description: At every study visit, urine samples will be collected and analyzed for ethyl glucuronide and drugs. This helps assess Contingency Management as a treatment for alcohol and/or drug dependence.
measure: Self- reported data on alcohol and drug use
time frame: 24 weeks
description: Measures used for self-reported data on alcohol and drug use:
The Alcohol and Drug Timeline Follow Back (TLFB)
The Current Opioid Misuse Measure (COMM)
The Addiction Severity Index, Native American Version (ASI-NAV)
measure: Other substance use
time frame: 24 weeks
description: Amphetamine, methamphetamine, cocaine, and marijuana, will be measured by the same procedures described for urine tests of alcohol and drug metabolites.
measure: Self- reported data on health behaviors
time frame: 24 weeks
description: We will also collect secondary outcome data on health behaviors that frequently correlate with alcohol and drug misuse with the following measures:
The Timeline Follow Back will be used to assess daily number of cigarettes smoked.
Brief HIV Risk Behavior Scale
Veteran's Rand- 12
Self-Report Services Utilization Assessment
measure: Measures used for descriptive purposes and to assess success of randomization.
time frame: 24 weeks
description: We will measure psychopathology with the Brief Symptom Inventory, a self-report instrument that will assess levels of anxiety, depression, impulsiveness, at baseline to characterize the psychiatric severity of the sample that has been used in previous studies of American Indians.
measure: Measures used for descriptive purposes and to assess success of randomization.
time frame: 24 weeks
description: The Fagerström Test of Nicotine Dependence will measure the presence and severity of nicotine dependence.
measure: Measures used for descriptive purposes and to assess success of randomization
time frame: 24 weeks
description: Interest in alcohol and drug abstinence will be assessed by the Stages of Change Readiness and Treatment Eagerness Scale.
measure: Measures used for descriptive purposes and to assess success of randomization
time frame: 24 weeks
description: In addition, other demographic, cultural, and cigarette smoking and alcohol use measures will be administered at baseline. These measures are part of the P20 Center Core measures. These measures include the Veteran's Rand-12 (already gathered as part of this study's protocol), the Behavioral Risk Factor Surveillance System Alcohol Survey, and demographic, cultural, and smoking behaviors (Behavioral Health Cooperative, Core Measures).
arm group label: CM for alcohol
arm group type: Experimental
description: CM for alcohol
arm group label: CM for drugs
arm group type: Experimental
description: CM for drugs
arm group label: CM for both substances
arm group type: Experimental
description: CM for both substances
arm group label: Non-Contingent group
arm group type: Other
description: No CM for either substance, the Non-Contingent (NC) group
intervention type: Behavioral
intervention name: CM for Alcohol
description: Escalating reinforcement for alcohol abstinence.
Alcohol-negative CM Participants draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say "good job!" or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize.
arm group label: CM for alcohol
intervention type: Behavioral
intervention name: CM for drugs
description: Escalating reinforcement for drug abstinence.
Drug-negative participants will be invited to draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say "good job!" or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize.
arm group label: CM for drugs
intervention type: Behavioral
intervention name: CM for both substances
description: Escalating reinforcement for drug and alcohol abstinence.
Drug- and alcohol-negative participants will be invited to draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say "good job!" or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize.
arm group label: CM for both substances
intervention type: Behavioral
intervention name: Non-Contingent group
description: Compensation for Non-Contingent control group participants is dependent only on providing urine samples, regardless of whether the urine tests are negative for alcohol and/or drugs.
arm group label: Non-Contingent group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mike McDonell, PhD
role: Principal Investigator
affiliation: Washington State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington State University
investigator full name: Michael McDonell
investigator title: Associate Director & Associate Professor