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Effect of D-amphetamine on Reward Functioning

NCT ID: NCT03369015

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-24

Study Completion Date

2019-05-23

Brief Summary

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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.

Detailed Description

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Conditions

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Anhedonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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

Group Type EXPERIMENTAL

10 mg d-amphetamine

Intervention Type DRUG

10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

20mg d-amphetamine

Intervention Type DRUG

20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

Placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

10 mg d-amphetamine

Intervention Type DRUG

10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

20mg d-amphetamine

Intervention Type DRUG

20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

Placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

10 mg d-amphetamine

Intervention Type DRUG

10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

20mg d-amphetamine

Intervention Type DRUG

20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

Placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

10 mg d-amphetamine

Intervention Type DRUG

10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

20mg d-amphetamine

Intervention Type DRUG

20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

Placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

10 mg d-amphetamine

Intervention Type DRUG

10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

20mg d-amphetamine

Intervention Type DRUG

20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

Placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

10 mg d-amphetamine

Intervention Type DRUG

10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

20mg d-amphetamine

Intervention Type DRUG

20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

Placebo

Intervention Type DRUG

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

Interventions

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10 mg d-amphetamine

10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

Intervention Type DRUG

20mg d-amphetamine

20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Scott Lane

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott D Lane, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-17-0604

Identifier Type: -

Identifier Source: org_study_id