NCT01392092

Completed

Effects of N-acetylcysteine on Brain Chemistry and Behavior ...

Wayne State University Source

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Other study identifiers

Sponsor study identifier

NAC-1

Study Type

observational

Actual enrollment (reported)

16

Locations

1 country

Sites

1

Timeline

Study Start

July 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

June 2017

Actual (reported)

Study Completion

June 2017

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 16 participants
Study completion date: June 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2011
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 11, 2011
Actual (reported)
First Posted
July 12, 2011
Actual (reported)
Primary Completion
June 2017
Actual (reported)
Study Completion
June 2017
Actual (reported)

Last Updated: April 5, 2018
Status Verified: April 2018
Last Update Submitted: April 3, 2018

Conditions

Cocaine Abuse or Dependence Cocaine Related Disorders

Keywords

Contingency ManagementDrug Self-Administration

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

Sampling MethodNon-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.

Sponsors & Collaborators

Wayne State University
Otherlead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

Mark Greenwald, PhD
Wayne State University
PRINCIPAL INVESTIGATOR

Enrollment

16 participants (actual enrollment reported by the registry).

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 2011

Date type not reported

This date has not been verified as actual or estimated.

NCT01148992

Interactions Between Intravenous (IV) Cocaine and Lofexidine

Phase 1Terminated

NCT00000215

IV Cocaine Abuse: A Laboratory Model - 4

Phase 2Completed

NCT00000201

Pharmacological Modulation of Cocaine Effects - 1

Phase 2Completed

NCT00000325

Psychostimulant Abuse - Novel Treatment Approaches - 1

Phase 1Completed

NCT04155632

Neurocircuit Strategy to Decrease Cocaine Cue Reactivity

Phase 2Completed

NCT00000348

Infusion Laboratory: Protocol 4 (Dihydrexidine) - 13

Phase 1Unknown

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).

Contact the study team to confirm eligibility.

Primary Completion

June 2017

Actual (reported)

Study Completion

June 2017

Actual (reported)

Last Updated

April 5, 2018

Record last verified: 2018-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01392092
Data provider: ClinicalTrials.gov
Source updated: 2018-04-05
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:57 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations