Effect of D-amphetamine on Reward Functioning
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
December 11, 2017
CompletedStudy Start
First participant enrolled
January 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2019
CompletedNovember 5, 2020
November 1, 2020
1.3 years
November 20, 2017
November 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session
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.
about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session
Secondary Outcomes (4)
Reward learning as assessed by the Effort Learning Task (ELT)
about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study sessions
Level of influence of counterfactual information on later decision-making, as measured by the Counterfactual Gambling Task (CGT)
about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session
Mood state as assessed by the Profile of Mood States (POMS)
15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions
Subjective effects of drug as assessed by the Drug Effects Questionnaire (DEQ)
15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions
Study Arms (6)
Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine
EXPERIMENTALPlacebo, then 20 mg d-amphetamine, then 10mg d-amphetamine
EXPERIMENTAL10 mg d-amphetamine, then placebo, then 20mg d-amphetamine
EXPERIMENTAL10 mg d-amphetamine, then 20mg d-amphetamine, then placebo
EXPERIMENTAL20 mg d-amphetamine, then 10mg d-amphetamine, then placebo
EXPERIMENTAL20 mg d-amphetamine, then placebo, then 10mg d-amphetamine
EXPERIMENTALInterventions
10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
Placebo dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
Eligibility Criteria
You may qualify if:
- \- Healthy individuals
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott D Lane, PhD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 20, 2017
First Posted
December 11, 2017
Study Start
January 24, 2018
Primary Completion
May 23, 2019
Study Completion
May 23, 2019
Last Updated
November 5, 2020
Record last verified: 2020-11