n-Acetylcysteine and Cocaine

NCT ID: NCT02141620

Last Updated: 2017-01-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-04-30

Brief Summary

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This study will determine the initial efficacy, safety and tolerability of n-acetylcysteine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and n-acetylcysteine.

Detailed Description

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Conditions

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Cocaine Abuse Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

Subjects will be maintained on oral placebo.

Group Type PLACEBO_COMPARATOR

Cocaine

Intervention Type DRUG

The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and n-acetylcysteine.

Placebo

Intervention Type DRUG

n-Acetylcysteine

Subjects will be maintained on oral n-acetylcysteine.

Group Type EXPERIMENTAL

Cocaine

Intervention Type DRUG

The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and n-acetylcysteine.

n-Acetylcysteine

Intervention Type DRUG

Interventions

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Cocaine

The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and n-acetylcysteine.

Intervention Type DRUG

n-Acetylcysteine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Current cocaine use
* Current cigarette smoker

Exclusion Criteria

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine or n-acetylcysteine
* History of schizophrenia in first degree relative
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role lead

Responsible Party

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William Stoops

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Kentucky Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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R21DA035376

Identifier Type: NIH

Identifier Source: org_study_id

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