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Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans (CAM)

Primary Purpose

Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
methamphetamine
placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Substance Abuse

Eligibility Criteria

21 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI of 19-26kg/m, high school education,
  • fluency in English,
  • resting blood pressure less than140/90mmHg and consumption of less than 4 standard alcohol or caffeinated drinks per day.

Exclusion Criteria:

  • current substance abuse or lifetime substance dependence,
  • regular medication,
  • history of cardiovascular illness,
  • current major Axis I DSM-IV disorder (APA, 2004),
  • mood disorder or psychotic symptoms within the past year.
  • Shift workers and pregnant or nursing mothers will also be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Paired, high reward

    Paired, low reward

    Paired no reward

    Unpaired, high reward

    Unpaired, low reward

    Arm Description

    All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.

    All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.

    All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.

    All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.

    All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.

    Outcomes

    Primary Outcome Measures

    Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire
    The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 30, 2014
    Last Updated
    June 29, 2018
    Sponsor
    University of Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02323048
    Brief Title
    Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans
    Acronym
    CAM
    Official Title
    Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans: Self-report, Behavioral, and Psychophysiological Measures.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Chicago

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to extend our investigations of drug-associated conditioning with healthy volunteers. The investigators have recently completed a pilot study demonstrating that subjects show an increase in self-reported preference for a visual stimulus paired with stimulant drug administration. Furthermore, our pilot data suggest that methamphetamine acts synergistically with rewards in the environment, such that this conditioning effect is facilitated by experiencing the drug in the presence of rewarding, or positive events, such as earning money. The investigators now aim to extend these findings by assessing not only self-reported preference, but also attentional and psychophysiological (electromyogram; EMG) responses to the drug-associated stimuli.
    Detailed Description
    The study will consist of an orientation session following by 6 experimental study sessions. The first experimental session will consist of a "Pre-test", where baseline data regarding attentional, psychophysiological, and self-reported responses tovarious stimuli will be collected. The following 4 sessions will consist of a drug (sedative or stimulant) or placebo. During these sessions, subjects will play simple computer games, as well as complete questionnaires regarding mood and potential subjective drug effects. The subjects will then complete a "Test" session, where attentional, psychophysiological, and self-reported responses to the stimuli will be assessed, as in the first experimental session.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Abuse

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    N/A
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Paired, high reward
    Arm Type
    Experimental
    Arm Description
    All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
    Arm Title
    Paired, low reward
    Arm Type
    Experimental
    Arm Description
    All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
    Arm Title
    Paired no reward
    Arm Type
    Experimental
    Arm Description
    All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
    Arm Title
    Unpaired, high reward
    Arm Type
    Experimental
    Arm Description
    All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
    Arm Title
    Unpaired, low reward
    Arm Type
    Experimental
    Arm Description
    All participants will be administered methamphetamine (20mg) and placebo. All subjects received methamphetamine (20 mg) on two conditioning sessions and placebo on the other two sessions, administered under double-blind conditions.
    Intervention Type
    Drug
    Intervention Name(s)
    methamphetamine
    Other Intervention Name(s)
    desoxyn
    Intervention Description
    : Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Other Intervention Name(s)
    dextrose
    Intervention Description
    Placebo (sugar pill)
    Primary Outcome Measure Information:
    Title
    Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire
    Description
    The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
    Time Frame
    End of study (time 0 and approximately 4 weeks later)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI of 19-26kg/m, high school education, fluency in English, resting blood pressure less than140/90mmHg and consumption of less than 4 standard alcohol or caffeinated drinks per day. Exclusion Criteria: current substance abuse or lifetime substance dependence, regular medication, history of cardiovascular illness, current major Axis I DSM-IV disorder (APA, 2004), mood disorder or psychotic symptoms within the past year. Shift workers and pregnant or nursing mothers will also be excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leah Mayo
    Organizational Affiliation
    Graduate Student
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans

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