n-Acetylcysteine and Cocaine

University of Kentucky

Status and phase: Completed; Early Phase 1

Conditions: Cocaine Dependence; Cocaine Abuse

Treatments: Drug: Placebo; Drug: Cocaine; Drug: n-Acetylcysteine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02141620

R21DA035376

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will be maintained on oral placebo.

Treatment:

Drug: Placebo

Drug: Cocaine

n-Acetylcysteine

Experimental group

Description:

Subjects will be maintained on oral n-acetylcysteine.

Treatment:

Drug: n-Acetylcysteine

Drug: Cocaine