n-Acetylcysteine and Cocaine

NCT02141620 | Completed Early Phase 1 Results

• 1 other identifier: R21DA035376
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine Abuse; Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative

  The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.

  One test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.

Secondary Outcomes (26)

• Peak Score on Sedative Subscale of the Adjective Rating Scale

  Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.

• Peak Score on Stimulant Subscale of the Adjective Rating Scale

  Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.

• Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale

  Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.

• Peak Ratings of "Any Effect" on the Visual Analog Scale

  Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.

• Peak Ratings of "Bad Effects" on the Visual Analog Scale

  Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will be maintained on oral placebo.

Drug: Cocaine; Drug: Placebo

n-Acetylcysteine

EXPERIMENTAL

Subjects will be maintained on oral n-acetylcysteine.

Drug: Cocaine; Drug: n-Acetylcysteine

Interventions

Cocaine DRUG

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

Placebo; n-Acetylcysteine

n-Acetylcysteine DRUG

n-Acetylcysteine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current cocaine use
• Current cigarette smoker

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kentucky: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, 40507, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Cocaine; Acetylcysteine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: William W. Stoops
• Organization: University of Kentucky

william.stoops@uky.edu

859-257-5388

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 19, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 4, 2017
• Results First Posted: October 6, 2016

Record last verified: 2016-11

Locations

US (1)