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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01392092
Date of registration:	11/07/2011
Prospective Registration:	No
Primary sponsor:	Wayne State University
Public title:	Effects of N-acetylcysteine on Brain Chemistry and Behavior in Cocaine Abusers (NAC) NAC
Scientific title:	Effects of N-acetylcysteine on Brain Chemistry and Behavior in Cocaine Abusers
Date of first enrolment:	July 2011
Target sample size:	16
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01392092
Study type:	Observational
Study design:
Phase:

Countries of recruitment
United States

Contacts

Name:	Mark Greenwald, PhD
Address:
Telephone:
Email:
Affiliation:	Wayne State University

Key inclusion & exclusion criteria

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).

Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cocaine Abuse or Dependence

Cocaine Related Disorders

Intervention(s)

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

NAC-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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