Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence

NCT ID: NCT02994875

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-09-30

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).

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Sugar pill

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

Group Type: ACTIVE_COMPARATOR

N-acetylcysteine

Intervention Type: DIETARY_SUPPLEMENT

NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications.

Interventions

N-acetylcysteine

NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Sugar pill

Intervention Type: OTHER

Other Intervention Names

NAC

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Yip, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1K01DA039299-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1510016617

Identifier Type: -

Identifier Source: org_study_id