Brain Mechanisms in Young Adults

NCT03606473 | Completed Early Phase 1 FDA Drug

• 1 other identifier: PRO17080203
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to use \[C-11\]NPA and amphetamine (oral, 0.5 mg/kg) to measure striatal dopamine transmission in prenatal cocaine exposed subjects (PCE) and comparison subjects (COMP)

Conditions

Cocaine-Related Disorders

Keywords

prenatal exposure

Outcome Measures

Primary Outcomes (1)

• Percent change in Binding potential (BPnd)

  DELTA BPND

  Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours

Study Arms (2)

Prenatal cocaine exposed subjects

EXPERIMENTAL

\[C-11\]NPA PET at baseline and post d-amphetamine

Drug: d-amphetamine; Radiation: [C-11]NPA

Comparison subjects

EXPERIMENTAL

\[C-11\]NPA PET at baseline and post d-amphetamine

Drug: d-amphetamine; Radiation: [C-11]NPA

Interventions

d-amphetamine DRUG

is used to stimulate dopamine release in the brain

Comparison subjects; Prenatal cocaine exposed subjects

[C-11]NPA RADIATION

PET radiotracer

Comparison subjects; Prenatal cocaine exposed subjects

Eligibility Criteria

• Age: 25 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• No current mania or psychosis based on current mental status exam and SCID-IV modules A (pages A18-A37) and B (pages B1-B8);
• No current cocaine, heroin, opioid, methadone, benzodiazepine, methamphetamine use (negative urine drug screen at both day of screening and the day of PET scan);
• Not currently taking prescription or over the counter medications that can alter monoamine transmission in the brain or interact with the d-amphetamine challenge or alter amphetamine concentrations (major CYP2D6 inhibitors such as fluoxetine, thioridazine, terbinafine etc., as well as pseudo-ephedrine, atomoxetine, SSRIs, etc.);
• No use of acidifying (fruit juice; beverages; ascorbic acid) and alkalinizing agents (such as sodium bicarbonate) that alter amphetamine concentrations at least 12 hrs before PET scan day;
• No current or past severe medical or neurological illnesses such as seizure disorders, head injury with prolonged loss of consciousness, hypertension, prior MI, CAD etc., (determined by physician investigator's elicited medical history, physical exam, review of labs, and EKG results);
• Not currently pregnant (serum pregnancy test at screening) or breastfeeding;
• No history of radioactivity exposure via prior nuclear medicine studies or occupational exposure in past 12 months;
• No metallic objects in the body that are contraindicated for MRI;
• SBP \> 135, DBP \> 85, and/or HR ≤ 50 or ≥ 100 (documented before the PET scans; Note: it is not unusual to have to repeat screening vital signs in subjects' because some subjects tend to have white coat syndrome and present with elevated vitals at screening, which later normalizes);
• No first-degree relative with an MI or stroke or TIA prior to 50 years of age;
• No first-degree relative with psychosis or mania.

Sponsors & Collaborators

• Gale Richardson: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: \[C-11\]NPA d-amphetamine

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 30, 2018
• Study Start: January 24, 2018
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)