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

Completed

Conditions studied: Cocaine Abuse or Dependence, Cocaine Related Disorders

In brief

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.

Key facts

Study ID

NCT01392092

Run by

Wayne State University

People needed

16

Starts

2011-07-01

Expected to finish

2017-06-01

Last updated by the study team

2018-04-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Wayne State University — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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