Brain Mechanisms in Young Adults

Cocaine-Related Disorders Clinical Trial

— MHP  

Official title:

Exploration of Mechanisms of Effects of Prenatal Cocaine Exposure in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606473
• Other study ID #: PRO17080203
• Status: Completed
• Phase: Early Phase 1
• Start date: January 24, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

Prenatal cocaine exposure (PCE) has consistently been associated with behavioral deficits through childhood, adolescence, and young adulthood in our ongoing study (PRO15080516 - Effects of Prenatal Cocaine Use: 25-Year Follow-Up). Further, 21-year-olds with PCE in our study were twice as likely to have been arrested as non-exposed offspring, were more likely to be diagnosed with Conduct Disorder, had higher disinhibition scores, were significantly more likely to use alcohol and marijuana earlier, and to have earlier sexual intercourse. The effects of PCE on the developing nervous system may cause changes in brain function that underlie these behavioral outcomes.

This study seeks to examine dopamine (DA) transmission in vivo, using positron emission tomography (PET) with [C-11]NPA, in striatal regions of interest in subjects who have a history of exposure to prenatal cocaine (PCE). We hypothesize that PCE is associated with increases in dopamine in the striatum relative to COMP. This may explain the impulsivity and high risk behaviors in PCE subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 30 Years

Eligibility

All potential subjects are current participants in the larger parent study entitled "Effects of Prenatal Cocaine Exposure: 25-Year Follow-Up", IRB PRO15080516. Participants are between 25 and 30 years of age.

Inclusion Criteria:

• Prenatal cocaine exposed subjects (PCE): Offspring exposed to prenatal cocaine (concurrent exposure to prenatal alcohol and tobacco are not exclusionary) as determined by detailed interviewing during pregnancy

• Comparison group (COMP): Offspring NOT exposed to prenatal cocaine (exposure to prenatal alcohol and tobacco are not exclusionary) as determined by detailed interviewing during pregnancy.

Exclusion criteria for both PCE and COMP groups:

• 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);

• No current use of cannabis (a negative urine drug screen on day of PET scan; Note: a positive cannabis urine on the day of screening will not be exclusionary because cannabis tends to be used for recreation; and it takes a long time for it turn negative because it is released from fat cells in body long after subject has quit; and it has been shown to not impact amphetamine-induced dopamine release in prior studies);

• 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.

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• d-amphetamine
is used to stimulate dopamine release in the brain

Radiation:
• [C-11]NPA
PET radiotracer

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gale Richardson	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in Binding potential (BPnd)	DELTA BPND	Baseline BPnd (time 0) and Post-amphetamine BPnd (time 3 hours