Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Cocaine Dependence
- Sponsor
- Yale University
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Change in neural network engagement measured using functional magnetic resonance imaging
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The objective of this research is to identify the functional neural mechanisms (as assessed using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained individuals with cocaine dependence.
Detailed Description
The objective of this research is to identify the functional neural mechanisms (as assessed using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained individuals with cocaine dependence. Specifically, this application proposes to conduct a randomized, double-blind, placebo-controlled, cross-over pilot study to examine the effects of 7-day NAC administration (2400mg/day) on the neural networks engaged during response inhibition (Go/No-Go task) and affective (emotion-regulation task) processes among cocaine-dependent, methadone-maintained individuals (n=40; 20 per treatment-order condition).
Investigators
Eligibility Criteria
Inclusion Criteria
- •enrollment in the APT methadone program and maintained on a stable dose of methadone for ≥ 2 weeks
- •males or females, aged 18-65
- •confirmed DSM-IV diagnosis of current cocaine use disorder as assessed at the screening assessment
- •for women of a child-bearing age, acceptable birth control method
- •ability to commit to 4 weeks of study participation plus 1-month follow-up
- •willingness to be randomized to NAC or placebo
- •eligibility for MRI scanning and willingness to participate in MRI scanning.
Exclusion Criteria
- •Do not meet DSM-IV criteria for cocaine-use disorder.
- •Meet DSM-IV psychiatric classifications for lifetime schizophrenia or bipolar disorder, or exhibit significant current suicidal or homicidal plans and intent such that hospitalization is required.
- •Meet DSM-IV criteria for current alcohol or other substance-use disorder dependence (with the exceptions of nicotine, cocaine and opioids).
- •Have previously taken or currently take NAC.
- •Have asthma (due to possible complications with NAC).
- •Cannot commit to 4-weeks of study participation or are unwilling to accept randomization.
- •Have any contraindications for MRI scanning (e.g., pregnancy, color-blindness, claustrophobia, metal implants that could interfere with MRI, any other contraindication to scanning).
- •Have lab work (complete blood count, urinalysis, liver function tests, thyroid function tests) suggesting the presence of any abnormalities or have a significant or unstable medical illness.
- •Are women who are pregnant or of a child-bearing age who do not agree to adequate contraception to prevent pregnancy during the study period.
- •Are not fluent in English.
Outcomes
Primary Outcomes
Change in neural network engagement measured using functional magnetic resonance imaging
Time Frame: 4 weeks
The primary outcome measure for this study is change (NAC versus placebo) in neural network engagement during fMRI task performance.