Brain Mechanisms in Young Adults

Completed · Early Phase 1

Conditions studied: Cocaine-Related Disorders

In brief

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)

Key facts

Study ID

NCT03606473

Run by

Gale Richardson

People needed

13

Starts

2018-01-24

Expected to finish

2020-08-31

Last updated by the study team

2020-09-03

Who can join

Age: 25 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.