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Effect of D-amphetamine on Reward Functioning

Primary Purpose

Anhedonia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
10 mg d-amphetamine
20mg d-amphetamine
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anhedonia focused on measuring Reward Learning, Decision Making

Eligibility Criteria

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

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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine

Placebo, then 20 mg d-amphetamine, then 10mg d-amphetamine

10 mg d-amphetamine, then placebo, then 20mg d-amphetamine

10 mg d-amphetamine, then 20mg d-amphetamine, then placebo

20 mg d-amphetamine, then 10mg d-amphetamine, then placebo

20 mg d-amphetamine, then placebo, then 10mg d-amphetamine

Arm Description

Outcomes

Primary Outcome Measures

Reward motivation as assessed by the Effort Expenditure for Reward Task (EEfRT)
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)
The Probabilistic Reward Task (PRT), which uses a signal detection paradigm, will be used to measure response bias towards rewarded stimuli.

Secondary Outcome Measures

Reward learning as assessed by the Effort Learning Task (ELT)
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)
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)
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)
The pharmacodynamics of d-amphetamine will be assessed throughout the study and will be used as a manipulation check.

Full Information

First Posted
November 20, 2017
Last Updated
November 3, 2020
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03369015
Brief Title
Effect of D-amphetamine on Reward Functioning
Official Title
Effect of D-amphetamine on Reward Functioning
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
May 23, 2019 (Actual)
Study Completion Date
May 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Emory University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anhedonia
Keywords
Reward Learning, Decision Making

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine
Arm Type
Experimental
Arm Title
Placebo, then 20 mg d-amphetamine, then 10mg d-amphetamine
Arm Type
Experimental
Arm Title
10 mg d-amphetamine, then placebo, then 20mg d-amphetamine
Arm Type
Experimental
Arm Title
10 mg d-amphetamine, then 20mg d-amphetamine, then placebo
Arm Type
Experimental
Arm Title
20 mg d-amphetamine, then 10mg d-amphetamine, then placebo
Arm Type
Experimental
Arm Title
20 mg d-amphetamine, then placebo, then 10mg d-amphetamine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
10 mg d-amphetamine
Intervention Description
10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
Intervention Type
Drug
Intervention Name(s)
20mg d-amphetamine
Intervention Description
20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
Primary Outcome Measure Information:
Title
Reward motivation as assessed by the Effort Expenditure for Reward Task (EEfRT)
Description
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.
Time Frame
about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session
Title
Reward learning as assessed by the Probabilistic Reward Task (PRT)
Description
The Probabilistic Reward Task (PRT), which uses a signal detection paradigm, will be used to measure response bias towards rewarded stimuli.
Time Frame
about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session
Secondary Outcome Measure Information:
Title
Reward learning as assessed by the Effort Learning Task (ELT)
Description
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.
Time Frame
about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study sessions
Title
Level of influence of counterfactual information on later decision-making, as measured by the Counterfactual Gambling Task (CGT)
Description
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.
Time Frame
about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session
Title
Mood state as assessed by the Profile of Mood States (POMS)
Description
The effect of d-amphetamine on mood state will be assessed throughout sessions and will be used as a manipulation check.
Time Frame
15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions
Title
Subjective effects of drug as assessed by the Drug Effects Questionnaire (DEQ)
Description
The pharmacodynamics of d-amphetamine will be assessed throughout the study and will be used as a manipulation check.
Time Frame
15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D Lane, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Effect of D-amphetamine on Reward Functioning

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