Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02994875
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 52
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Dietary Supplement: N-acetylcysteine; Other: Placebo	Early Phase 1

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo First Placebo - Participants will receive placebo for one week. Following a two-week washout period, they will receive NAC for one week. NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications	Other: Placebo; Sugar pill
Active Comparator: NAC First N-acetylcysteine - Participants will receive NAC for one week. Following a two-week washout period, they will receive placebo for one week. NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications	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 Names: NAC

Outcome Measures

Primary Outcome Measures

1. Change in neural network engagement measured using functional magnetic resonance imaging [4 weeks]

   The primary outcome measure for this study is change (NAC versus placebo) in neural network engagement during fMRI task performance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Sarah Yip, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02994875
• Other Study ID Numbers: 1510016617; 1K01DA039299-01A1
• First Posted: Dec 16, 2016
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Cocaine-Related Disorders; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Oct 5, 2020