AnhedoniaPhase 1NCT03369015
Effect of D-amphetamine on Reward Functioning
A Phase 1 study testing 10 mg d-amphetamine and 20mg d-amphetamine in people with Anhedonia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anhedonia
- What is being tested?
- 10 mg d-amphetamine and 20mg d-amphetamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2018to 23 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Anhedonia
- Being tested
- 10 mg d-amphetamine, 20mg d-amphetamine, Placebo
- Keywords
- Reward Learning, Decision Making
- Medical subject headings
- Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg d-amphetamineDrug
10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
20mg d-amphetamineDrug
20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
PlaceboDrug
Placebo dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
| Study group | Role | What they receive |
|---|---|---|
| Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine | Experimental | Not described Receives: Drug: 10 mg d-amphetamine; Drug: 20mg d-amphetamine; Drug: Placebo |
| Placebo, then 20 mg d-amphetamine, then 10mg d-amphetamine | Experimental | Not described Receives: Drug: 10 mg d-amphetamine; Drug: 20mg d-amphetamine; Drug: Placebo |
| 10 mg d-amphetamine, then placebo, then 20mg d-amphetamine | Experimental | Not described Receives: Drug: 10 mg d-amphetamine; Drug: 20mg d-amphetamine; Drug: Placebo |
| 10 mg d-amphetamine, then 20mg d-amphetamine, then placebo | Experimental | Not described Receives: Drug: 10 mg d-amphetamine; Drug: 20mg d-amphetamine; Drug: Placebo |
| 20 mg d-amphetamine, then 10mg d-amphetamine, then placebo | Experimental | Not described Receives: Drug: 10 mg d-amphetamine; Drug: 20mg d-amphetamine; Drug: Placebo |
| 20 mg d-amphetamine, then placebo, then 10mg d-amphetamine | Experimental | Not described Receives: Drug: 10 mg d-amphetamine; Drug: 20mg d-amphetamine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
The effect of d-amphetamine on mood state will be assessed throughout sessions and will be used as a manipulation check.
Measured: 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)
The pharmacodynamics of d-amphetamine will be assessed throughout the study and will be used as a manipulation check.
Measured: 15 minutes before receiving drug and 30, 90, 180, and 210 minutes after receiving drug at 1st, 2nd, and 3rd study sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start24 Jan 2018
- Primary completion23 May 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnhedoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Scott Lane, The University of Texas Health Science Center, Houston
- Investigators
- Scott D Lane, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369015
- Sponsor's protocol ID
- HSC-MS-17-0604
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2017
- Last updated
- 5 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of D-amphetamine on Reward Functioning
- ClinicalTrials.gov ID
- NCT03369015
- Acronym / sponsor ID
- HSC-MS-17-0604
- Conditions
- Anhedonia
- Keywords
- Reward Learning, Decision Making
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine | Experimental | Drug: 10 mg d-amphetamine, Drug: 20mg d-amphetamine, Drug: Placebo |
| Placebo, then 20 mg d-amphetamine, then 10mg d-amphetamine | Experimental | Drug: 10 mg d-amphetamine, Drug: 20mg d-amphetamine, Drug: Placebo |
| 10 mg d-amphetamine, then placebo, then 20mg d-amphetamine | Experimental | Drug: 10 mg d-amphetamine, Drug: 20mg d-amphetamine, Drug: Placebo |
| 10 mg d-amphetamine, then 20mg d-amphetamine, then placebo | Experimental | Drug: 10 mg d-amphetamine, Drug: 20mg d-amphetamine, Drug: Placebo |
| 20 mg d-amphetamine, then 10mg d-amphetamine, then placebo | Experimental | Drug: 10 mg d-amphetamine, Drug: 20mg d-amphetamine, Drug: Placebo |
| 20 mg d-amphetamine, then placebo, then 10mg d-amphetamine | Experimental | Drug: 10 mg d-amphetamine, Drug: 20mg d-amphetamine, Drug: Placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 mg d-amphetamine10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered. | Drug | 10 mg d-amphetamine, then 20mg d-amphetamine, then placebo, 10 mg d-amphetamine, then placebo, then 20mg d-amphetamine, 20 mg d-amphetamine, then 10mg d-amphetamine, then placebo, 20 mg d-amphetamine, then placebo, then 10mg d-amphetamine, Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine, Placebo, then 20 mg d-amphetamine, then 10mg d-amphetamine |
| 20mg d-amphetamine20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered. | Drug | 10 mg d-amphetamine, then 20mg d-amphetamine, then placebo, 10 mg d-amphetamine, then placebo, then 20mg d-amphetamine, 20 mg d-amphetamine, then 10mg d-amphetamine, then placebo, 20 mg d-amphetamine, then placebo, then 10mg d-amphetamine, Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine, Placebo, then 20 mg d-amphetamine, then 10mg d-amphetamine |
| PlaceboPlacebo dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered. | Drug | 10 mg d-amphetamine, then 20mg d-amphetamine, then placebo, 10 mg d-amphetamine, then placebo, then 20mg d-amphetamine, 20 mg d-amphetamine, then 10mg d-amphetamine, then placebo, 20 mg d-amphetamine, then placebo, then 10mg d-amphetamine, Placebo, then 10 mg d-amphetamine, then 20mg d-amphetamine, Placebo, then 20 mg d-amphetamine, then 10mg d-amphetamine |
Primary outcome
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.
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
Related trials for Anhedonia
Recruiting
Promoting Positive Emotions in Adolescents Using Positive Events Training: An Indicated Approach
Emotional Distress, Anhedonia
RecruitingPhase 3
Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
Bipolar Disorder (BD)
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Recruiting
Geolocation Positional System (GPS) Experience
Emotions, Anhedonia
Not yet recruitingObservational study
Anhedonia Beyond Depressive Symptoms in Children and Adolescents With Conduct Disorder
Conduct Disorder, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott D Lane, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10 mg d-amphetamine and 20mg d-amphetamine in people with Anhedonia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.