Clinical trial NCT02141620: n-Acetylcysteine and Cocaine
Official title: Motivation for Cocaine and Non-Drug Reinforcers: Targeting Glutamate Homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine Abuse
Cocaine Dependence
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-05-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
timeFrame: One test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.
Secondary outcomes:
measure: Peak Score on Sedative Subscale of the Adjective Rating Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Score on Stimulant Subscale of the Adjective Rating Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Any Effect" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Bad Effects" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Euphoric" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Good Effects" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "High" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Like Drug" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Nauseous" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Nervous/Anxious" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Willing to Pay For" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Performance Impaired" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Performance Improved" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Restless" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Rush" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Shaky/Jittery" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Sluggish/Fatigued/Lazy" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Stimulated" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Willing to Take Again" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Ratings of "Talkative/Friendly" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Diastolic Blood Pressure
timeFrame: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Systolic Blood Pressure
timeFrame: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Heart Rate
timeFrame: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
measure: Peak Temperature
timeFrame: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Laboratory of Human Behavioral Pharmacology
state: Kentucky
Study officials:
References: