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Trial record 5 of 75 for:    AMPHETAMINE AND DEXTROAMPHETAMINE

Effect of D-amphetamine on Reward Functioning

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ClinicalTrials.gov Identifier: NCT03369015
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
Scott Lane, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE November 20, 2017
First Posted Date  ICMJE December 11, 2017
Last Update Posted Date July 16, 2018
Actual Study Start Date  ICMJE January 24, 2018
Estimated Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • Reward motivation as assessed by the Effort Expenditure for Reward Task (EEfRT) [ Time Frame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session ]
    A measure of effort-based decision-making in humans, the Effort Expenditure for Reward Task (EEfRT), will be used. The EEfRT requires participants to choose between a low-effort, low reward task vs a high-effort, high reward task. Willingness to exert effort, or reward motivation, is measured by taking the average number of hard task choices from the first 50 trials.
  • Reward learning as assessed by the Probabilistic Reward Task (PRT) [ Time Frame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session ]
    The Probabilistic Reward Task (PRT), which uses a signal detection paradigm, will be used to measure response bias towards rewarded stimuli.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03369015 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • Reward learning as assessed by the Effort Learning Task (ELT) [ Time Frame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study sessions ]
    The novel Effort Learning Task (ELT) will be used, in which participants learn to associate abstract shapes with reward, loss, high effort and low effort outcomes, to examine the effect of dopaminergic stimulation on reward learning. Learning rates are determined for each symbol, and trial-wise learning curves are calculated as metrics of reward learning.
  • Level of influence of counterfactual information on later decision-making, as measured by the Counterfactual Gambling Task (CGT) [ Time Frame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session ]
    Striatal dopamine is involved in signalling counterfactual information, i.e. encoding differences between the value of actual outcomes and hypothetical outcomes of alternative choices. The CGT is a gambling task used to assess the relationship between choice factors (available options, expected value, and outcomes) on self-reported measures of momentary happiness and regret. Participants complete a gambling task and are informed of their outcome and of the counterfactual outcome (i.e. hypothetical outcome had the participant selected another option). With this task, the degree to which participants make choices to avoid potential regret can be estimated.
  • Mood state as assessed by the Profile of Mood States (POMS) [ Time Frame: 15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions ]
    The effect of d-amphetamine on mood state will be assessed throughout sessions and will be used as a manipulation check.
  • Subjective effects of drug as assessed by the Drug Effects Questionnaire (DEQ) [ Time Frame: 15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions ]
    The pharmacodynamics of d-amphetamine will be assessed throughout the study and will be used as a manipulation check.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of D-amphetamine on Reward Functioning
Official Title  ICMJE Effect of D-amphetamine on Reward Functioning
Brief Summary The purpose of this study is to establish the dose-response curve for therapeutic doses of d-amphetamine on tasks of motivation and reward learning in the same participants and to use d-amphetamine as a dopaminergic probe to test newer theories about the role of dopamine in reward-related decision-making.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Anhedonia
Intervention  ICMJE
  • Drug: 10 mg d-amphetamine
    10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
  • Drug: 20mg d-amphetamine
    20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
  • Drug: Placebo
    Placebo dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
Study Arms  ICMJE
  • Experimental: Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine
    Interventions:
    • Drug: 10 mg d-amphetamine
    • Drug: 20mg d-amphetamine
    • Drug: Placebo
  • Experimental: Placebo, then 20 mg d-amphetamine, then 10mg d-amphetamine
    Interventions:
    • Drug: 10 mg d-amphetamine
    • Drug: 20mg d-amphetamine
    • Drug: Placebo
  • Experimental: 10 mg d-amphetamine, then placebo, then 20mg d-amphetamine
    Interventions:
    • Drug: 10 mg d-amphetamine
    • Drug: 20mg d-amphetamine
    • Drug: Placebo
  • Experimental: 10 mg d-amphetamine, then 20mg d-amphetamine, then placebo
    Interventions:
    • Drug: 10 mg d-amphetamine
    • Drug: 20mg d-amphetamine
    • Drug: Placebo
  • Experimental: 20 mg d-amphetamine, then 10mg d-amphetamine, then placebo
    Interventions:
    • Drug: 10 mg d-amphetamine
    • Drug: 20mg d-amphetamine
    • Drug: Placebo
  • Experimental: 20 mg d-amphetamine, then placebo, then 10mg d-amphetamine
    Interventions:
    • Drug: 10 mg d-amphetamine
    • Drug: 20mg d-amphetamine
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2018
Estimated Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Healthy individuals

Exclusion Criteria:

  • Individuals with a body mass index (BMI) <19 or >26, as this alters dosing requirements
  • Individuals with high blood pressure, abnormal Electrocardiography (EKG), any medical condition requiring regular medication (except birth control), any other regular use of a drug or supplement with potentially hazardous interactions with d-amphetamine (e.g. St. John's wort), or any other medical contraindication to amphetamine administration as determined by our study physician
  • Individuals who report no prior experience with recreational drugs of any kind (including alcohol), or who report a previous adverse reaction to amphetamine
  • Individuals with a current Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) Axis I diagnosis, excluding mild Substance Use Disorders (≤ 3 symptoms)
  • Individuals with a lifetime history of moderate to severe Substance Use Disorder (≥ 4 symptoms), mania or psychosis.
  • Women who are pregnant.
  • individuals smoking more than 10 cigarettes per week will also be excluded, to avoid confounding the effects of nicotine withdrawal with the effects of the study drugs/procedures, as participants will not be allowed to smoke during the sessions.
  • individuals with less than a high-school level of education or fluency in English will be excluded as our questionnaires require high-school level fluency in English, and have not been translated and validated in other languages.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Scott D Lane, PhD 713-486-2578 ms.CNRAresearch@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03369015
Other Study ID Numbers  ICMJE HSC-MS-17-0604
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Scott Lane, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Emory University
Investigators  ICMJE
Principal Investigator: Scott D Lane, PhD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP