Effects of N-acetylcysteine on Brain Chemistry and Behavior in Cocaine Abusers (NAC)

NCT01392092 | Completed DMC

• 1 other identifier: NAC-1
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

N-acetylcysteine (NAC) is a medication that the Food and Drug Administration (FDA) has approved for several medical uses, such as dissolving mucus in patients with breathing problems, treating overdose from acetaminophen (Tylenol), and protecting the kidneys from toxic substances. Some recent studies suggest that NAC could be useful in the treatment of other disorders including addictions. One purpose of this study is to determine whether NAC alters the level of brain glutamate (a chemical that excites brain cells). The other main purpose is to determine whether NAC affects how much cocaine people use.

Conditions

Cocaine Abuse or Dependence; Cocaine Related Disorders

Keywords

Contingency Management; Drug Self-Administration

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cocaine abusing or dependent research volunteers

You may qualify if:

• Male and female volunteers (18-55 years of age)
• Must meet DSM-IV criteria for current Cocaine Abuse or Dependence and wish to participate in research.
• Positive urine test for cocaine.
• Candidates must be in good health to be eligible.
• All candidates must receive routine medical (history and physical) exam with standard laboratory tests (complete blood chemistry, urinalysis, urine pregnancy test for females, tuberculin screening), and 12-lead ECG at the initial screening visit.

You may not qualify if:

• Serious psychiatric illness (e.g. psychosis, bipolar, suicide attempts, major depression that is not substance-induced).
• Substance use disorder other than cocaine abuse or dependence, nicotine dependence, alcohol abuse, sedative abuse or marijuana abuse.
• Neurological diseases (e.g. stroke, seizures); cardiovascular problems (e.g. myocardial infarction, angina, systolic BP \>160 or \<95 mmHg, diastolic BP \>95 mmHg, or clinically abnormal ECG); pulmonary diseases (e.g. asthma, TB); systemic diseases (e.g. hepatitis, autoimmune diseases).
• Cognitive impairment.
• Exposed in past 30 days to medications that would increase study risk (e.g. toxicity to major organ systems, psychotropics, asthma inhalers, or interactions with study drugs).
• Pregnant (urine HCG), lactating (self-report), or if heterosexually active and not using (self-report) medically approved birth control measures (oral or depot contraceptives, IUD, condom/foam, sterilization, tubal ligation).
• Seeking treatment or being treated for a substance use disorder.
• Metal objects in body (e.g. metal plates, part of a bullet from a gunshot wound, or a catheter).

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark Greenwald, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)