Clinical trial NCT03369015: Effect of D-amphetamine on Reward Functioning
Official title: Effect of D-amphetamine on Reward Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anhedonia
Keywords: Reward Learning
Decision Making
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2017-12-11
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Reward motivation as assessed by the Effort Expenditure for Reward Task (EEfRT)
timeFrame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session
measure: Reward learning as assessed by the Probabilistic Reward Task (PRT)
timeFrame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session
Secondary outcomes:
measure: Reward learning as assessed by the Effort Learning Task (ELT)
timeFrame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study sessions
measure: Level of influence of counterfactual information on later decision-making, as measured by the Counterfactual Gambling Task (CGT)
timeFrame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session
measure: Mood state as assessed by the Profile of Mood States (POMS)
timeFrame: 15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions
measure: Subjective effects of drug as assessed by the Drug Effects Questionnaire (DEQ)
timeFrame: 15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Scott D Lane, PhD
role: PRINCIPAL_INVESTIGATOR
References: