CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 65 enrolled
Drug / intervention
Dextroamphetamine +3 moredrug
Likely dose
Dextroamphetamine 0.43mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03512171
NCT03512171Phase 1Completed
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Dopaminergic Neuromodulation of Decision Making in Young and Middle-Aged Adults

Vanderbilt University·interventional·Posted Apr 30, 2018·Updated Jun 27, 2019

In Brief

A Phase 1 clinical trial evaluating Dextroamphetamine, Placebo, and 2 other interventions for Healthy Adults. Completed, enrolled 65 participants across 1 site.

Detailed Summary

Financial decisions are made during pre-retirement age that can influence financial well-being for the rest of an individual's life. This proposal aims to construct a more comprehensive model of the specific psychological and neural mechanisms that support financial decisions in young adulthood and late middle age. In Part 1 of this study (covered in Institutional Review Board (IRB) # 141812), middle-age and young adults complete basic cognitive, motivational, and decision making tasks and are studied with functional magnetic resonance imaging (fMRI) to determine the relation between neural circuit activation and individual and age-related differences in decision making. In part II of the study, aspects of dopamine functioning are studied using positron emission tomography (PET) scanning to determine whether individual differences in dopamine functions are related to the decision-making and fMRI measures collected in Part 1 of the study. Dopamine measures include baseline D2 receptor availability, amphetamine induced dopamine release and dopamine transporter (DAT) levels, which provides a more comprehensive evaluation of dopamine functions than in prior studies linking individual differences in dopamine to behavioral, cognitive or decision-making traits.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adults
CountriesUnited States
CollaboratorsDuke University

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 30, 2018
Enrollment StartMar 31, 2016
Primary CompletionMay 15, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.2 years ago

Interventions

Dextroamphetaminedrug

One oral dose of dextroamphetamine (0.43mg/kg). The amphetamine is given in order to induce the release of their own dopamine for study with positron emission tomography (PET).

Placebodrug

One oral dose of placebo to estimate D2 receptor levels at baseline with PET imaging (necessary to calculate dopamine release in the amphetamine condition).

[18F]Fallyprideother

Radioligand for measuring dopamine D2 receptors with positron emission tomography (PET)

[18F]-FE-PE2Iother

Radioligand for measuring dopamine transporters with positron emission tomography (PET)