<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/NCT01722006</url>
  </required_header>
  <id_info>
    <org_study_id>10-618A</org_study_id>
    <secondary_id>R01DA002812</secondary_id>
    <secondary_id>HHSN275201100328P</secondary_id>
    <nct_id>NCT01722006</nct_id>
  </id_info>
  <brief_title>Drug Effects on Preference and Reward</brief_title>
  <official_title>Drug Effects on Preference and Reward</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Classical conditioning is widely used to study motivational properties of addictive drugs in&#xD;
      animals, but has rarely been used in humans. Here, we are establishing a procedure suitable&#xD;
      for studying the neurobiology and individual determinants of classical conditioning in&#xD;
      humans. Healthy volunteers are randomly assigned to four groups that received methamphetamine&#xD;
      or placebo in the presence of distinctive environmental cues under paired or unpaired&#xD;
      conditions. During each session, subjects perform tasks known to activate the ventral&#xD;
      striatum in fMRI studies. The tasks are performed in the presence of a distinctive context,&#xD;
      consisting of a screen background image of a beach or of mountains, accompanied by&#xD;
      corresponding sounds. Separate groups of subjects carry out the tasks under high or low&#xD;
      reward conditions. Within each of the two reward conditions, one group (paired), receives&#xD;
      methamphetamine (20 mg, oral) or placebo consistently associated with one of the contexts,&#xD;
      while the other (unpaired) receives drug or placebo unrelated to context. A fifth group&#xD;
      (paired) perform the tasks with contextual cues but in the absence of monetary incentives.&#xD;
      Before and after conditioning, participants carry out a series of forced choice tasks, and&#xD;
      change of preference over time was analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects are assigned to one of 5 groups: Paired, high reward (PairHi; n=24); Paired, low&#xD;
      reward (PairLo; n=24); Paired no reward (PairNone; n=23); Unpaired, high reward (UnpHi; n=7);&#xD;
      and Unpaired, low-reward (UnpLo; n=9). Each participant attends an orientation session,&#xD;
      followed by four 4h conditioning sessions separated by at least 48h, and a 2h test session.&#xD;
      During the initial orientation session, subjects practice the computer tasks together with&#xD;
      the environmental stimuli to be paired during the conditioning sessions, and carry out a&#xD;
      series of choices for the tasks and images (see below). All subjects receive methamphetamine&#xD;
      (20 mg) on two conditioning sessions and placebo on the other two sessions, administered&#xD;
      under double-blind conditions. Subjects differ in whether environmental stimuli are&#xD;
      consistently paired with the drug administration. The three paired groups consistently&#xD;
      receive drug and placebo in combination with one of the two sets of visual and auditory&#xD;
      background stimuli (see below). The two unpaired groups receive each treatment in combination&#xD;
      with one of the stimuli sets on one session, and the other on the other.&#xD;
&#xD;
      During all four conditioning sessions, subjects perform a series of computer tasks. Depending&#xD;
      on group assignment, subjects are able to earn high ( PairHi, UnpHi) or low monetary reward (&#xD;
      PairLo, UnpLo), but this is not contingent on subjects' performance. Each run for each game&#xD;
      begins with a credit to prevent a negative outcome early in the run. The PairNone group play&#xD;
      the same games without monetary reward. The order of the three games and the background&#xD;
      images used are randomized across subjects, but remain constant within subjects.&#xD;
&#xD;
      Tasks are presented in the presence of the two distinctive compound stimuli consisting of a&#xD;
      background screen visible behind the task presentation and accompanied by a corresponding&#xD;
      sound. One set of stimuli depicts a summer beach view accompanied by the sound of ocean&#xD;
      waves. The other depicts summer alpine scenery accompanied by birdsong.&#xD;
&#xD;
      The primary outcome measure is the change in preference ratings for the study stimuli, from&#xD;
      before to after conditioning. This is a behavioral study, designed to develop a novel&#xD;
      procedure for future imaging studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Preference for paired stimulus</measure>
    <time_frame>2-3 weeks</time_frame>
    <description>Subjects rate their preference for several pairs of stimuli before and after conditioning pairings. The stimuli are presented on a computer screen in the pre and post preference tests, and the change in preference after the conditioning trials is the primary outcome measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective responses to methamphetamine</measure>
    <time_frame>2-3 weeks</time_frame>
    <description>Subjects complete standardized mood questionnaires after receiving methamphetamine or placebo on each of the four conditioning trials. Blood pressure and heart rate are also measured at these times.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">103</enrollment>
  <condition>Drug Addiction</condition>
  <arm_group>
    <arm_group_label>Pairing group</arm_group_label>
    <description>Paired, high reward, oral methamphetamine (20 mg) vs placebo Paired, low reward, oral methamphetamine (20 mg) vs placebo Paired, no reward, oral methamphetamine (20 mg) vs placebo Unpaired, oral methamphetamine (20 mg) vs placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pairing condition</intervention_name>
    <arm_group_label>Pairing group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pairing condition</intervention_name>
    <description>20 mg methamphetamine or placebo on four 4-hour laboratory sessions</description>
    <arm_group_label>Pairing group</arm_group_label>
    <other_name>Paired, unpaired</other_name>
    <other_name>Low, high or no reward</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        healthy adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-35, good healthy, normal weight, high school education, normal electrocardiogram,&#xD;
             no psychiatric disorders,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current medications, night shift work, abnormal electrocardiogram, medical problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harriet de Wit, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>September 4, 2013</last_update_submitted>
  <last_update_submitted_qc>September 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>methamphetamine</keyword>
  <keyword>subjective</keyword>
  <keyword>conditioning</keyword>
  <keyword>preference</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/NCT01722006
org study id: 10-618A
secondary id: R01DA002812
secondary id: HHSN275201100328P
nct id: NCT01722006
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Classical conditioning is widely used to study motivational properties of addictive drugs in
      animals, but has rarely been used in humans. Here, we are establishing a procedure suitable
      for studying the neurobiology and individual determinants of classical conditioning in
      humans. Healthy volunteers are randomly assigned to four groups that received methamphetamine
      or placebo in the presence of distinctive environmental cues under paired or unpaired
      conditions. During each session, subjects perform tasks known to activate the ventral
      striatum in fMRI studies. The tasks are performed in the presence of a distinctive context,
      consisting of a screen background image of a beach or of mountains, accompanied by
      corresponding sounds. Separate groups of subjects carry out the tasks under high or low
      reward conditions. Within each of the two reward conditions, one group (paired), receives
      methamphetamine (20 mg, oral) or placebo consistently associated with one of the contexts,
      while the other (unpaired) receives drug or placebo unrelated to context. A fifth group
      (paired) perform the tasks with contextual cues but in the absence of monetary incentives.
      Before and after conditioning, participants carry out a series of forced choice tasks, and
      change of preference over time was analyzed.
Subjects are assigned to one of 5 groups: Paired, high reward (PairHi; n=24); Paired, low
      reward (PairLo; n=24); Paired no reward (PairNone; n=23); Unpaired, high reward (UnpHi; n=7);
      and Unpaired, low-reward (UnpLo; n=9). Each participant attends an orientation session,
      followed by four 4h conditioning sessions separated by at least 48h, and a 2h test session.
      During the initial orientation session, subjects practice the computer tasks together with
      the environmental stimuli to be paired during the conditioning sessions, and carry out a
      series of choices for the tasks and images (see below). All subjects receive methamphetamine
      (20 mg) on two conditioning sessions and placebo on the other two sessions, administered
      under double-blind conditions. Subjects differ in whether environmental stimuli are
      consistently paired with the drug administration. The three paired groups consistently
      receive drug and placebo in combination with one of the two sets of visual and auditory
      background stimuli (see below). The two unpaired groups receive each treatment in combination
      with one of the stimuli sets on one session, and the other on the other.

      During all four conditioning sessions, subjects perform a series of computer tasks. Depending
      on group assignment, subjects are able to earn high ( PairHi, UnpHi) or low monetary reward (
      PairLo, UnpLo), but this is not contingent on subjects' performance. Each run for each game
      begins with a credit to prevent a negative outcome early in the run. The PairNone group play
      the same games without monetary reward. The order of the three games and the background
      images used are randomized across subjects, but remain constant within subjects.

      Tasks are presented in the presence of the two distinctive compound stimuli consisting of a
      background screen visible behind the task presentation and accompanied by a corresponding
      sound. One set of stimuli depicts a summer beach view accompanied by the sound of ocean
      waves. The other depicts summer alpine scenery accompanied by birdsong.

      The primary outcome measure is the change in preference ratings for the study stimuli, from
      before to after conditioning. This is a behavioral study, designed to develop a novel
      procedure for future imaging studies.
observational model: Case-Only
measure: Preference for paired stimulus
time frame: 2-3 weeks
description: Subjects rate their preference for several pairs of stimuli before and after conditioning pairings. The stimuli are presented on a computer screen in the pre and post preference tests, and the change in preference after the conditioning trials is the primary outcome measure.
measure: Subjective responses to methamphetamine
time frame: 2-3 weeks
description: Subjects complete standardized mood questionnaires after receiving methamphetamine or placebo on each of the four conditioning trials. Blood pressure and heart rate are also measured at these times.
arm group label: Pairing group
description: Paired, high reward, oral methamphetamine (20 mg) vs placebo Paired, low reward, oral methamphetamine (20 mg) vs placebo Paired, no reward, oral methamphetamine (20 mg) vs placebo Unpaired, oral methamphetamine (20 mg) vs placebo
intervention type: Behavioral
intervention name: Pairing condition
arm group label: Pairing group
intervention type: Behavioral
intervention name: Pairing condition
description: 20 mg methamphetamine or placebo on four 4-hour laboratory sessions
arm group label: Pairing group
other name: Paired, unpaired
other name: Low, high or no reward
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harriet de Wit, PhD
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders