Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]

Sponsor
Craig Rush (Other)
Overall Status
Completed
CT.gov ID
NCT04178993
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
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2
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Study Details

Study Description

Brief Summary

This study will evaluate the behavioral effects of methamphetamine during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
A Novel Drug Combination as a Pharmacotherapeutic for Methamphetamine-Use Disorder
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
May 5, 2021
Actual Study Completion Date :
May 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo Comparator: Placebo

Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.

Drug: Methamphetamine
In each arm, subjects will receive doses of methamphetamine.
Other Names:
  • Metamfetamine
  • Drug: Methylphenidate
    In each arm, subjects will receive methylphenidate capsules.
    Other Names:
  • Metadate®
  • Drug: Placebo oral capsule
    In each arm, subjects will receive placebo capsules.
    Other Names:
  • Lactose
  • Active Comparator: Active Comparator: Duloxetine

    Subjects will be maintained on oral duloxetine. Subjects will be maintained on duloxetine and methylphenidate during placebo maintenance. Methamphetamine will be administered acutely during duloxetine maintenance. Placebo will be administered acutely during duloxetine maintenance.

    Drug: Methamphetamine
    In each arm, subjects will receive doses of methamphetamine.
    Other Names:
  • Metamfetamine
  • Drug: Methylphenidate
    In each arm, subjects will receive methylphenidate capsules.
    Other Names:
  • Metadate®
  • Drug: Placebo oral capsule
    In each arm, subjects will receive placebo capsules.
    Other Names:
  • Lactose
  • Drug: Duloxetine
    Subjects will receive duloxetine capsules in the duloxetine arm.
    Other Names:
  • Cymbalta®
  • Outcome Measures

    Primary Outcome Measures

    1. Reinforcing Effects of Methamphetamine Following Placebo Maintenance. [Following at least 4 days of maintenance on placebo during inpatient admission]

      Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement.

    2. Reinforcing Effects of Methamphetamine Following Duloxetine Maintenance. [Following at least 4 days of maintenance on duloxetine during inpatient admission]

      Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement.

    3. Reinforcing Effects of Methamphetamine Following Methylphenidate Maintenance. [Following at least 4 days of maintenance on methylphenidate during inpatient admission]

      Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement.

    4. Reinforcing Effects of Methylphenidate Following Methylphenidate and Duloxetine Maintenance [Following at least 4 days of maintenance on methylphenidate and duloxetine during inpatient admission.]

      Number of methamphetamine doses earned by subjects on a progressive ratio schedule of reinforcement

    Secondary Outcome Measures

    1. Drug Effect Questionnaire [12 sessions over approximately 4.5 weeks of study participation]

      Subjects will complete the drug effect questionnaire during nine sessions while they are admitted to our inpatient unit. The items (total scores=0-100; Higher scores=greater drug effect) on this scale categorize the constellation of drug effects endorsed by subjects.

    2. Heart rate [Daily over approximately 4.5 weeks of inpatient stay.]

      Beats per minute. Measured daily during inpatient admission.

    3. Blood pressure [Daily over approximately 4.5 weeks of inpatient stay.]

      mmHg.Measured daily during inpatient admission.

    4. Temperature [Daily over approximately 4.5 weeks of inpatient stay.]

      Degrees fahrenheit. Measured daily during inpatient admission.

    5. Side effects [Daily over approximately 4.5 weeks of inpatient stay.]

      Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.

    Other Outcome Measures

    1. Attentional Bias [12 sessions over approximately 4.5 weeks of study participation]

      Subjects will complete attentional bias during 12 sessions while they are admitted to our inpatient unit. Time attending to drug stimuli will be used to evaluate attentional bias.

    2. Delay Discounting Task [12 sessions over approximately 4.5 weeks of study participation]

      Subjects will complete the delay discounting task during twelve sessions while they are admitted to our inpatient unit. Responses will be used to calculate discounting slope (i.e., K).

    3. Anhedonia (Inability to experience pleasure) [12 sessions over approximately 4.5 weeks of study participation]

      A 14-item pleasure scale covers four domains of pleasure response: interest/pastimes, social interaction, sensory experience and food/drink.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • recent use of inhaled (i.e., snorted), smoked or injected methamphetamine
    Exclusion Criteria:
    • Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant.

    • Current or past histories of substance use that are deemed by the study physicians to interfere with study completion.

    • History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation.

    • Females not currently using effective birth control.

    • Contraindications to methamphetamine, methylphenidate, or duloxetine.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kentucky Lexington Kentucky United States 40507
    2 University of Kentucky Medical Center Lexington Kentucky United States 40536

    Sponsors and Collaborators

    • Craig Rush
    • National Institute on Drug Abuse (NIDA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Craig Rush, Professor, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT04178993
    Other Study ID Numbers:
    • BED(IN):40
    • R01DA047391
    First Posted:
    Nov 26, 2019
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Dec 1, 2021

    Study Results

    No Results Posted as of Jan 21, 2022