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Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence

Primary Purpose

Cocaine Dependence

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

N-acetylcysteine

Placebo

About this trial

This is an interventional treatment trial for Cocaine Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
Do not have at least a 6th grade reading level.
Cannot provide written, informed consent.

Sites / Locations

Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo First

NAC First

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02994875

First Posted

July 11, 2016

Last Updated

September 30, 2020

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT02994875

Brief Title

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

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

September 2020 (Actual)

Study Completion Date

September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo First

Arm Type

Placebo Comparator

Arm Description

Arm Title

NAC First

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

N-acetylcysteine

Other Intervention Name(s)

NAC

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Sugar pill

Primary Outcome Measure Information:

Title

Change in neural network engagement measured using functional magnetic resonance imaging

Description

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

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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. Do not have at least a 6th grade reading level. Cannot provide written, informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah Yip, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence

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