n-Acetylcysteine and Cocaine

Cocaine Dependence Clinical Trial

Official title:

Motivation for Cocaine and Non-Drug Reinforcers: Targeting Glutamate Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141620
• Other study ID #: R21DA035376
• Status: Completed
• Phase: Phase 0
• First received: May 13, 2014
• Last updated: May 10, 2016
• Start date: May 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cocaine Abuse
• Cocaine Dependence

Intervention

Drug:
• Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and n-acetylcysteine.
• n-Acetylcysteine

• Placebo

Locations

Country	Name	City	State
United States	University of Kentucky Laboratory of Human Behavioral Pharmacology	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Kentucky	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reinforcing Effects	The reinforcing effects of cocaine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo and n-acetylcysteine.	After at least seven days of placebo or n-acetylcysteine maintenance	No
Secondary	Subjective Effects	Subjects will complete subjective effects measures during six sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood.	6 sessions over approximately 2 week inpatient admissions	Yes
Secondary	Physiological Effects	Physiological measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include heart rate and blood pressure.	Daily over approximately 2 week inpatient admissions	Yes
Secondary	Side Effects	Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.	Daily over approximately two weeks of inpatient admission.	Yes