Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence

NCT02994875 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 15100166171K01DA039299-01A1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo First

PLACEBO COMPARATOR

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

NAC First

ACTIVE COMPARATOR

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

Interventions

N-acetylcysteine DIETARY_SUPPLEMENT

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

Also known as: NAC

NAC First

Placebo OTHER

Sugar pill

Placebo First

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sarah Yip, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: December 16, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

US (1)