ClinicalTrials.gg
CompletedNCT03369015Updated Nov 5, 2020

Effect of D-amphetamine on Reward Functioning

A Phase 1 interventional study of 10 mg d-amphetamine and 20mg d-amphetamine in Anhedonia, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-05.

Sponsored by The University of Texas Health Science Center, Houston · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was May 2019, 7 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 76 studies in Anhedonia with a site in United States — 24 open to participants now, 25 under way, none of them phase 3. Anhedonia · United States.

Enrollment
36th of 67
68 · median 70
Started
2018
with 1 other
Phase 1
5 of 76
1 open now
Registered
21st of 76
by date

Among the 76 studies in Anhedonia with a site in United States, this one is the 36th largest by enrollment of the 67 interventional ones that give a count, is one of 2 that started in 2018, is one of 5 in phase 1, and was the 21st registered.

Anhedonia

134 studies on the registry are indexed under Anhedonia; 50 are open to participants now.

Browse Anhedonia studies →

Open to participants now

24 of the 76 studies in Anhedonia with a site in United States are open now. Recruiting first, the newest first:

19 more — sign in →

All 24 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 43 Anhedonia studies recruiting now, 8 (19%) set no upper age limit and 33 (77%) stop at 75 or younger; 8 take children under 18; 14 take healthy volunteers.

This study: 18 Years to 35 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • Anhedonia

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Keywords

  • Reward Learning
  • Decision Making
04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy individuals

Exclusion criteria

Exclusion Criteria:

  • Individuals with a (BMI) \<19 or >26, as this alters dosing requirements
  • Individuals with high blood pressure, abnormal Electrocardiography (), any medical condition requiring regular medication (except ), 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 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 -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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

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

    Drug: 10 mg d-amphetamine · Drug: 20mg d-amphetamine · Drug: Placebo

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

    Drug: 10 mg d-amphetamine · Drug: 20mg d-amphetamine · Drug: Placebo

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

    Drug: 10 mg d-amphetamine · Drug: 20mg d-amphetamine · Drug: Placebo

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

    Drug: 10 mg d-amphetamine · Drug: 20mg d-amphetamine · Drug: Placebo

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

    Drug: 10 mg d-amphetamine · Drug: 20mg d-amphetamine · Drug: Placebo

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

    Drug: 10 mg d-amphetamine · Drug: 20mg d-amphetamine · Drug: Placebo

Interventions

  • 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.

  • DrugPlacebo

    Placebo dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session

  2. 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.

    Time frame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session

Secondary outcomes

  1. 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.

    Time frame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study sessions

  2. 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.

    Time frame: about 100 minutes to 140 minutes after receiving drug at 1st, 2nd, and 3rd study session

  3. 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.

    Time frame: 15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions

  4. 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.

    Time frame: 15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions

07

Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in May 2019, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2017
First posted
Dec 11, 2017
StartActual
Jan 24, 2018
Primary completionActual
May 23, 2019
CompletionActual
May 23, 2019
Last update
Nov 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03369015
Collaborators
Emory University
Responsible party
Scott Lane (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Dec 11, 2017
Start date
Jan 24, 2018
Primary completion
May 23, 2019
Completion
May 23, 2019
Last update
Nov 5, 2020

Study contacts

Scott D Lane, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dextroamphetamine

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