<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/NCT02253589</url>
  </required_header>
  <id_info>
    <org_study_id>01DG13020</org_study_id>
    <nct_id>NCT02253589</nct_id>
  </id_info>
  <brief_title>Motivational Interviewing (MI) to Reduce Khat Use</brief_title>
  <acronym>MIkhat</acronym>
  <official_title>Evaluation of Motivational Interviewing (MI) to Reduce Khat Use Among Somali Refugees in Kenya</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Konstanz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Africa Mental Health Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Konstanz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Healthy khat user with the intention to reduce or stop khat use will be randomly assigned to&#xD;
      a one-session brief intervention or waiting list. Reductions in khat use will be measured&#xD;
      from pre- to post-assessment which will be one month apart. After one month, the waiting list&#xD;
      will receive the same intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The leaves of the khat tree are traditionally chewed in some African and Arab countries. They&#xD;
      contain the mild central stimulant cathinone. In recent years, the production, trade and use&#xD;
      has dramatically increased and excessive patterns of use as well as a specific dependence&#xD;
      syndrome have been described. So far, no experiences exist in psychological treatment of khat&#xD;
      addiction.&#xD;
&#xD;
      In this study, we use a brief motivational intervention based on the WHO's ASSIST-linked&#xD;
      Brief Intervention and Motivational Interviewing to support users who have the intention to&#xD;
      reduce or stop their khat use. Khat users will be recruited in the community. Trained local&#xD;
      staff will assess participant's khat and other substance use at study entry and one month&#xD;
      later. Users will be assigned randomly to intervention or waiting list control groups. The&#xD;
      intervention group will receive a single 20-minute brief intervention. The waiting list will&#xD;
      receive the same intervention after the second assessment. After two months, a final&#xD;
      assessment will be made in both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time-Line-Follow-Back: Self-reported days with khat use and amount of khat use</measure>
    <time_frame>one month</time_frame>
    <description>Participants report in a calender for each day of the past month whether they used khat and how much of it.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time-Line-Follow-Back: other substance use</measure>
    <time_frame>One month</time_frame>
    <description>Participants report for each day of the past month whether they used other substances of abuse, i.e. alcohol, illegal drugs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Khat Use Disorder</condition>
  <arm_group>
    <arm_group_label>Waiting list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will assessment only during study, same intervention after posttest</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to this arm will receive the modified ASSIST-linked Brief Intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>modified ASSIST-linked Brief Intervention</intervention_name>
    <description>Trained counsellors support participant's motivation to reduce or stop khat use in a 20 minute counselling session.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Motivational Interviewing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy individuals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Severe psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tawakal Clinic</name>
      <address>
        <city>Nairobi</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>May 10, 2017</last_update_submitted>
  <last_update_submitted_qc>May 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Konstanz</investigator_affiliation>
    <investigator_full_name>Michael Odenwald</investigator_full_name>
    <investigator_title>Researcher</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/NCT02253589
org study id: 01DG13020
nct id: NCT02253589
lead sponsor: 
collaborator: 
has dmc: No
Healthy khat user with the intention to reduce or stop khat use will be randomly assigned to
      a one-session brief intervention or waiting list. Reductions in khat use will be measured
      from pre- to post-assessment which will be one month apart. After one month, the waiting list
      will receive the same intervention.
The leaves of the khat tree are traditionally chewed in some African and Arab countries. They
      contain the mild central stimulant cathinone. In recent years, the production, trade and use
      has dramatically increased and excessive patterns of use as well as a specific dependence
      syndrome have been described. So far, no experiences exist in psychological treatment of khat
      addiction.

      In this study, we use a brief motivational intervention based on the WHO's ASSIST-linked
      Brief Intervention and Motivational Interviewing to support users who have the intention to
      reduce or stop their khat use. Khat users will be recruited in the community. Trained local
      staff will assess participant's khat and other substance use at study entry and one month
      later. Users will be assigned randomly to intervention or waiting list control groups. The
      intervention group will receive a single 20-minute brief intervention. The waiting list will
      receive the same intervention after the second assessment. After two months, a final
      assessment will be made in both groups.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time-Line-Follow-Back: Self-reported days with khat use and amount of khat use
time frame: one month
description: Participants report in a calender for each day of the past month whether they used khat and how much of it.
measure: Time-Line-Follow-Back: other substance use
time frame: One month
description: Participants report for each day of the past month whether they used other substances of abuse, i.e. alcohol, illegal drugs
arm group label: Waiting list
arm group type: No Intervention
description: Participants will assessment only during study, same intervention after posttest
arm group label: Intervention
arm group type: Experimental
description: Participants assigned to this arm will receive the modified ASSIST-linked Brief Intervention
intervention type: Behavioral
intervention name: modified ASSIST-linked Brief Intervention
description: Trained counsellors support participant's motivation to reduce or stop khat use in a 20 minute counselling session.
arm group label: Intervention
other name: Motivational Interviewing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Kenya
responsible party type: Principal Investigator
investigator affiliation: University of Konstanz
investigator full name: Michael Odenwald
investigator title: Researcher