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Trial record 7 of 35 for:    Anhedonia

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

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.

Condition or disease Intervention/treatment Phase
Anhedonia Drug: 10 mg d-amphetamine Drug: 20mg d-amphetamine Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effect of D-amphetamine on Reward Functioning
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine 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.

Experimental: Placebo, then 20 mg d-amphetamine, then 10mg d-amphetamine 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.

Experimental: 10 mg d-amphetamine, then placebo, then 20mg d-amphetamine 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.

Experimental: 10 mg d-amphetamine, then 20mg d-amphetamine, then placebo 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.

Experimental: 20 mg d-amphetamine, then 10mg d-amphetamine, then placebo 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.

Experimental: 20 mg d-amphetamine, then placebo, then 10mg d-amphetamine 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369015


Contacts
Contact: Scott D Lane, PhD 713-486-2578 ms.CNRAresearch@uth.tmc.edu

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Scott D Lane, PhD    713-486-2578    ms.CNRAresearch@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Emory University
Investigators
Principal Investigator: Scott D Lane, PhD The University of Texas Health Science Center, Houston

Responsible Party: Scott Lane, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03369015     History of Changes
Other Study ID Numbers: HSC-MS-17-0604
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

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

Keywords provided by Scott Lane, The University of Texas Health Science Center, Houston:
Reward Learning
Decision Making

Additional relevant MeSH terms:
Anhedonia
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Amphetamine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors