Cocaine Related Disorders Clinical Trial
— NACOfficial title:
Effects of N-acetylcysteine on Brain Chemistry and Behavior in Cocaine Abusers
Verified date | April 2018 |
Source | Wayne State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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). |
Country | Name | City | State |
---|---|---|---|
United States | Wayne State University | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Wayne State University |
United States,
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