Clinical trial NCT01639157: Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine
Official title: Human Laboratory Study of the Impact of Buspirone Maintenance on the Reinforcing, Subjective and Performance Effects of Cocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Use Disorders
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-07-12
Enrollment: 9
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: Cocaine use disorders are an unrelenting public health concern. Intensive research efforts have yielded behavioral interventions that reduce cocaine use, however, these interventions are not universally effective and treatment effects diminish over time. Development of a pharmacotherapy that enhances the efficacy of these interventions is a priority for the National Institute on Drug Abuse. This study proposes to determine the impact of buspirone maintenance on self-administration of cocaine and alternative reinforcers. These preliminary data will be used to support further research developing buspirone as a pharmacotherapy for cocaine use disorders. We hypothesize that buspirone will attenuate the reinforcing effects of cocaine and increase the reinforcing effects of alternative reinforcers.


Eligibility criteria: Inclusion Criteria:

* Recent cocaine use

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 buspirone

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 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone and placebo maintenance conditions.
measure: Peak Ratings of "Nauseated, Queasy, Sick to Stomach" on the Visual Analog Scale
timeFrame: Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone 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 buspirone and placebo maintenance conditions.
measure: Peak Oral Temperature
timeFrame: This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone 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 buspirone 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 buspirone and placebo maintenance conditions.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: William W Stoops, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stoops WW, Lile JA, Glaser PE, Hays LR, Rush CR. Intranasal cocaine functions as reinforcer on a progressive ratio schedule in humans. Eur J Pharmacol. 2010 Oct 10;644(1-3):101-5. doi: 10.1016/j.ejphar.2010.06.055. Epub 2010 Jul 16.