<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/NCT03285256</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00138474</org_study_id>
    <nct_id>NCT03285256</nct_id>
  </id_info>
  <brief_title>Effects of Repeated Memory Training on Memory Function and Addiction Related Processes</brief_title>
  <official_title>Effects of Repeated Memory Training on Memory Function and Addiction Related Processes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective memory is the ability to implement an intention to the future (e.g. remember to&#xD;
      take medication, attend a scheduled meeting), and has receive little attention in addiction.&#xD;
      The investigators propose that prospective memory plays a critical, yet unrecognized, role in&#xD;
      major human behavior change such as that required in addiction treatment. This study will&#xD;
      determine the preliminary efficacy of prospective memory training in improving memory and&#xD;
      executive functions while reducing illicit drug use in methadone patients. Participants will&#xD;
      be randomly assigned to one of three conditions: an experimental memory training program or&#xD;
      one of two comparator memory training programs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to recruit participants before funding period ended.&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</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>
    <intervention_model_description>Participants will be randomly assigned to one of three treatment conditions: an experimental memory training program or one of two comparator memory training programs.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Both the participant and the research assistant conducting the assessments will be blinded to group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in prospective memory over course of training</measure>
    <time_frame>one month</time_frame>
    <description>Prospective memory will be evaluated within the program itself and measured as the percentage of correct responses within the program. Higher percentages are indicative of greater prospective memory performance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in drug use and substance abuse over course of training.</measure>
    <time_frame>one month</time_frame>
    <description>Drug use will be evaluated by urinalysis. Negative screens are indicative of drug abstinence.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Substance-Related Disorders</condition>
  <arm_group>
    <arm_group_label>Experimental Memory Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental memory training program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator Memory Training 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comparator memory training program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator Memory Training 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Alternative comparator memory training program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Experimental memory training</intervention_name>
    <description>The experimental memory training will be implemented as a computer program that uses state-of-the-art immersive technology to simulate prospective memory in everyday life in which one must remember to carry out tasks throughout the day, while engaging in current ongoing activity. Participants are asked to imagine they have a work-at-home job (ongoing activity), which is an independent program (CogMed QM) designed to train working memory, but that they also need to remember to carry out a number of tasks throughout the day. Using a touch screen, participants will need to touch objects in the simulated environment to appropriately interact with these stimuli according to their pre-assigned tasks.</description>
    <arm_group_label>Experimental Memory Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Comparator memory training 1</intervention_name>
    <description>The first comparator memory training intervention will utilize the same overall structure and immersive computer environment as the experimental memory intervention, but will not challenge the same aspects of cognition.</description>
    <arm_group_label>Comparator Memory Training 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Comparator memory training 2</intervention_name>
    <description>The second comparator memory training intervention will utilize the same overall structure and immersive computer environment as the experimental memory intervention, but will not challenge the same aspects of cognition.</description>
    <arm_group_label>Comparator Memory Training 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-55; provision of written consent&#xD;
&#xD;
          -  Enrolled in a substance use treatment program&#xD;
&#xD;
          -  Sex with ≥ 2 partners in the last 30 days and sex without a condom on at least one&#xD;
             occasion in the last year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe psychiatric conditions associated with psychosis or any unstable psychiatric&#xD;
             condition&#xD;
&#xD;
          -  History of medical, psychiatric, or neurological conditions associated with&#xD;
             significant cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew W Johnson, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins University School of Medicine, Bayview Campus</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>January 8, 2020</last_update_submitted>
  <last_update_submitted_qc>January 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prospective memory, working memory, substance abuse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03285256
org study id: IRB00138474
nct id: NCT03285256
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective memory is the ability to implement an intention to the future (e.g. remember to
      take medication, attend a scheduled meeting), and has receive little attention in addiction.
      The investigators propose that prospective memory plays a critical, yet unrecognized, role in
      major human behavior change such as that required in addiction treatment. This study will
      determine the preliminary efficacy of prospective memory training in improving memory and
      executive functions while reducing illicit drug use in methadone patients. Participants will
      be randomly assigned to one of three conditions: an experimental memory training program or
      one of two comparator memory training programs.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to one of three treatment conditions: an experimental memory training program or one of two comparator memory training programs.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Both the participant and the research assistant conducting the assessments will be blinded to group assignment.
measure: Change in prospective memory over course of training
time frame: one month
description: Prospective memory will be evaluated within the program itself and measured as the percentage of correct responses within the program. Higher percentages are indicative of greater prospective memory performance.
measure: Change in drug use and substance abuse over course of training.
time frame: one month
description: Drug use will be evaluated by urinalysis. Negative screens are indicative of drug abstinence.
arm group label: Experimental Memory Training
arm group type: Experimental
description: Experimental memory training program
arm group label: Comparator Memory Training 1
arm group type: Active Comparator
description: Comparator memory training program
arm group label: Comparator Memory Training 2
arm group type: Active Comparator
description: Alternative comparator memory training program
intervention type: Behavioral
intervention name: Experimental memory training
description: The experimental memory training will be implemented as a computer program that uses state-of-the-art immersive technology to simulate prospective memory in everyday life in which one must remember to carry out tasks throughout the day, while engaging in current ongoing activity. Participants are asked to imagine they have a work-at-home job (ongoing activity), which is an independent program (CogMed QM) designed to train working memory, but that they also need to remember to carry out a number of tasks throughout the day. Using a touch screen, participants will need to touch objects in the simulated environment to appropriately interact with these stimuli according to their pre-assigned tasks.
arm group label: Experimental Memory Training
intervention type: Behavioral
intervention name: Comparator memory training 1
description: The first comparator memory training intervention will utilize the same overall structure and immersive computer environment as the experimental memory intervention, but will not challenge the same aspects of cognition.
arm group label: Comparator Memory Training 1
intervention type: Behavioral
intervention name: Comparator memory training 2
description: The second comparator memory training intervention will utilize the same overall structure and immersive computer environment as the experimental memory intervention, but will not challenge the same aspects of cognition.
arm group label: Comparator Memory Training 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Matthew W Johnson, Ph.D.
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: Undecided