Overview

Glutamate-Glutamine Cycling (VCYC) During Cocaine Abstinence Using 1H-MRS

Status:
Active, not recruiting
Trial end date:
2023-11-01
Target enrollment:
0
Participant gender:
All
Summary
This study is designed to look at the relationship between brain glucose utilization, neurotransmission (e.g., glutamate, also known as the main excitatory amino-acid neurotransmitter in the brain), and synaptic density. This relationship will be explored in the brain's prefrontal cortex, an area important in decision-making and impulsivity.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Yale University
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Acetylcysteine
N-monoacetylcystine
Pentoxifylline
Riluzole
Criteria
Inclusion Criteria:

1. Age 18-55 years;

2. Voluntary, written, informed consent;

3. Physically healthy by medical history, physical, neurological, ECG and laboratory
examinations;

4. DSM-IV criteria for Cocaine Dependence (304.20) (Note: subjects will also meet DSM-5
criteria for Cocaine Use Disorder);

5. Documented evidence (by urine toxicology) of abstinence from cocaine (2 weeks for scan
1, and 2 and 4 weeks for scans 2 and 3, respectively)

6. Full scale and verbal IQs > 80;

7. For females, a negative serum pregnancy test (β-HCG) at screening and negative urine
pregnancy test on PET scan day prior to imaging.

Exclusion Criteria:

1. A history of other substance dependence (e.g., alcohol, opiates, sedative hypnotics),
except for nicotine;

2. A primary DSM-IV Axis I major psychiatric disorder (e.g., schizophrenia, bipolar
disorder, major depression, etc.) as determined by the Structured Clinical Interview
for DSM-IV (SCID);

3. A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or
neurological (e.g., cerebrovascular, seizure, traumatic brain injury) illness;

4. Current use of psychotropic and/or potentially psychoactive prescription medications;

5. Medical contraindications to participation in a magnetic resonance imaging procedure
(e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker,
prosthetic valve, otologic implant, etc.);

6. For females, laboratory (β-HCG) evidence of pregnancy, physical evidence of pregnancy;

7. For subjects interested in pharmacotherapy component, history of allergies to NAC and
current elevation on liver function tests above twice the normal limit;

8. Subjects with history of prior radiation exposure for research purposes within the
past year such that participation in this study would place them over FDA limits for
annual radiation exposure. This guideline is an effective dose of 5 rem received per
year;

9. Subjects with current, past or anticipated exposure to radiation in the work place
within one year of proposed research PET scans;

10. History of a bleeding disorder or are currently taking anticoagulants (such as
Coumadin, Heparin, Pradaxa, Xarelto);

11. Blood donation within eight weeks of the start of the study.