Decision Making Study in Young and Middle-Aged Adults: Part II

NCT03512171 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 151088AG043458
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Dopamine D2 receptor availability (binding potential)

  D2 receptor availability is measured using positron emission tomography (PET) and the D2/D3 receptor radioligand \[18F\] fallypride. Contrast between receptor availability after amphetamine versus placebo forms the primary measure of dopamine release induced by amphetamine.

  3- 6.5 hours

Secondary Outcomes (8)

• Quantification of Dopamine Transporter Levels

  0 - 2 hours

• Decision Making Task 1

  1-3 hours

• Decision Making Task 2

  1-3 hours

• Cognitive Task 1 (processing speed)

  1 - 2 hours

• Cognitive Task 2 (verbal fluency)

  1 - 2 hours

Study Arms (3)

Amphetamine

EXPERIMENTAL

One oral dose of dextroamphetamine (0.43 mg/kg) up to a maximum dose of 45mg. The dose is administered in 10mg and 2.5mg capsules prepared by the Vanderbilt Investigational Drug Services (IDS). Note: We are not testing the effect of dextro-amphetamine on a symptom. Rather it is part of the diagnostic intervention that is used to measure dopamine release assessed as the decline in \[18F\]fallypride binding relative to baseline.

Drug: Dextroamphetamine; Diagnostic Test: [18F]Fallypride

Placebo

PLACEBO COMPARATOR

One oral placebo dose, with capsules prepared by the Vanderbilt Investigational Drug Services (IDS). This provides the baseline against which dopamine release is measured.

Drug: Placebo; Diagnostic Test: [18F]Fallypride

[18F]-FE-PE2I

EXPERIMENTAL

\[18F\]-FE-PE2I is a radioligand for measuring dopamine transporters with positron emission tomography (PET). All participants complete this arm. The arm does not include administration of amphetamine or placebo.

Diagnostic Test: [18F]-FE-PE2I

Interventions

Dextroamphetamine DRUG

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).

Also known as: d-amphetamine

Amphetamine

Placebo DRUG

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

Placebo

[18F]Fallypride DIAGNOSTIC_TEST

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

Also known as: [18F]Fallypride positron emission tomography

Amphetamine; Placebo

[18F]-FE-PE2I DIAGNOSTIC_TEST

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

Also known as: [18F]-FE-PE2I positron emission tomography

[18F]-FE-PE2I

Eligibility Criteria

• Age: 20 Years - 65 Years
• Gender Eligibility Details: Total number of participants planned is 60 broken into 30 females and 30 males.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically, psychiatrically and neurologically healthy individuals between the 20-30 or 50-65 years of age. Subjects must be able to give informed consent, have an estimated intelligence quotient of greater than 80, and be a fluent English speaker.

You may not qualify if:

• History of major psychiatric illness (including recurrent major depressive episodes or a depressive episode in the past 10 years, any anxiety disorders in the last 10 years, any history of bipolar disorder or psychotic disorder, a history of substance dependence (or substance abuse lasting more than 2 years), or any eating disorder in which symptoms persisted for more than two years
• Current tobacco use, alcohol intake greater than 8 ounces of whiskey or equivalent per week, use of any psychotropic medication for the past 6 months (other than occasional use of benzodiazepines for sleep), psychostimulants taken more than 5 times in the subject's life, current marijuana use 4 Neurological illness (other than headache or strictly peripheral nerve disturbance), or head trauma (including more than 2 concussions)
• \) History of Syncope during blood draws 7) Anemia or hematocrit \< 34. 8) Participation in any research studies in the past year that involved radiation, or exposure to radiation on a routine basis due to their occupation.
• \) High blood pressure (Systolic B.P. \> 150 in participants under the age of 61, or \> 145 in subjects \> 61 years of age). Diagnosis of labile hypertension. Abnormal EKG indicating potential cardiac risk under conditions of increased blood pressure.
• \) Current pregnancy or lactation or plans to become pregnant during the study timeframe.

Sponsors & Collaborators

• Vanderbilt University: lead
• Duke University: collaborator

Study Sites (1)

Zald Affective Neuroscience Lab- Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

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MeSH Terms

Interventions

Dextroamphetamine

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• David Zald, Zald

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participant and the research analyst running their session are both blind, however a PET tech is unmasked who monitors the participant for any adverse reactions.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cornelius Vanderbilt Professor of Psychology and Professor of Psychiatry

Model Details: All subjects receive the same diagnositc intervention, with counterbalanced order

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 30, 2018
• Study Start: March 31, 2016
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)