Clinical Trials Directory

Trials / Completed

CompletedNCT02124941

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Yale University · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGN-acetyl cysteineUpon completion of baseline (abstinence) 1H-MRS scanning, CU and HC subjects will participate in two additional 1H-MRS scans, including after 2 weeks of placebo and 2 weeks of NAC administration (3600 mg/day) given in double-blind, randomized, counterbalanced order.
DIAGNOSTIC_TEST[18F]FDG PET scanAll subjects will undergo \[18F\]FDG PET to establish previously demonstrated reductions in glucose utilization in PFC and assess VS/nucleus accumbent metabolism at baseline.
DIAGNOSTIC_TEST1H MRSAll subjects will undergo three magnetic resonance spectroscopy (1H-MRS) scans at 7T, including before and after two-weeks of placebo and NAC administration.
DIAGNOSTIC_TEST[11C]APP311 PET scanAll subjects will undergo \[11C\]APP311 PET imaging to investigate whether there are differences in synaptic integrity / neuronal plasticity in the brains of individuals abstinent from cocaine compared to healthy controls at baseline.

Timeline

Start date
2014-02-01
Primary completion
2022-08-14
Completion
2022-08-14
First posted
2014-04-28
Last updated
2023-07-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02124941. Inclusion in this directory is not an endorsement.