Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence

Cocaine Dependence Clinical Trial

Official title:

Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02994875
• Other study ID #: 1510016617
• Secondary ID: 1K01DA039299-01A
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2016
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Dietary Supplement:
• N-acetylcysteine
NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications.

Other:
• Placebo
Sugar pill

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neural network engagement measured using functional magnetic resonance imaging	The primary outcome measure for this study is change (NAC versus placebo) in neural network engagement during fMRI task performance.	4 weeks