Clinical trial NCT02994875: Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence
Official title: Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-12-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. enrollment in the APT methadone program and maintained on a stable dose of methadone for ≥ 2 weeks
2. males or females, aged 18-65
3. confirmed DSM-IV diagnosis of current cocaine use disorder as assessed at the screening assessment
4. for women of a child-bearing age, acceptable birth control method
5. ability to commit to 4 weeks of study participation plus 1-month follow-up
6. willingness to be randomized to NAC or placebo
7. eligibility for MRI scanning and willingness to participate in MRI scanning.

Exclusion Criteria:

1. Do not meet DSM-IV criteria for cocaine-use disorder.
2. 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.
3. Meet DSM-IV criteria for current alcohol or other substance-use disorder dependence (with the exceptions of nicotine, cocaine and opioids).
4. Have previously taken or currently take NAC.
5. Have asthma (due to possible complications with NAC).
6. Cannot commit to 4-weeks of study participation or are unwilling to accept randomization.
7. Have any contraindications for MRI scanning (e.g., pregnancy, color-blindness, claustrophobia, metal implants that could interfere with MRI, any other contraindication to scanning).
8. 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.
9. 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.
10. Are not fluent in English.
11. Do not have at least a 6th grade reading level.
12. Cannot provide written, informed consent.

Primary outcomes:
measure: Change in neural network engagement measured using functional magnetic resonance imaging
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Sarah Yip, PhD
role: PRINCIPAL_INVESTIGATOR
References: