Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine

Cocaine Use Disorders Clinical Trial

Official title:

Human Laboratory Study of the Impact of Buspirone Maintenance on the Reinforcing, Subjective and Performance Effects of Cocaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639157
• Other study ID #: R21DA034095-01
• Status: Completed
• Phase: N/A
• First received: July 10, 2012
• Last updated: January 22, 2016
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

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 Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• Buspirone
Subjects will be maintained on oral buspirone (10 mg administered 3 times daily) for 6 days each during the study in random order.
• Placebo
Subjects will be maintained on oral placebo (0 mg administered 3 times daily) for 6 days each during the study in random order.

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
William Stoops	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 2 week inpatient admission	No
Secondary	Peak Score on Sedative Subscale of the Adjective Rating Scale	Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 "sedative" items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Systolic Blood Pressure	Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Score on Stimulant Subscale of the Adjective Rating Scale	Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 "sedative" items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Active, Alert, Energetic" on the Visual Analog Scale	Subjects rated their feelings of "Active, Alert, Energetic" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Any Effect" on the Visual Analog Scale	Subjects rated their feelings of "Any Effect" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Bad Effects" on the Visual Analog Scale	Subjects rated their feelings of "Bad Effects" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Euphoric" on the Visual Analog Scale	Subjects rated their feelings of "Euphoric" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Good Effects" on the Visual Analog Scale	Subjects rated their feelings of "Good Effects" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "High" on the Visual Analog Scale	Subjects rated their feelings of "High" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Irregular/Racing Heartbeat" on the Visual Analog Scale	Subjects rated their feelings of "Irregular/Racing Heartbeat" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Like Drug" on the Visual Analog Scale	Subjects rated their feelings of "Like Drug" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Nauseated, Queasy, Sick to Stomach" on the Visual Analog Scale	Subjects rated their feelings of "Nauseated, Queasy, Sick to Stomach" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Nervous, Anxious" on the Visual Analog Scale	Subjects rated their feelings of "Nervous, Anxious" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Willing to Pay For" on the Visual Analog Scale	Subjects rated their feelings of "Willing to Pay For" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Performance Impaired" on the Visual Analog Scale	Subjects rated their feelings of "Performance Impaired" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Performance Improved" on the Visual Analog Scale	Subjects rated their feelings of "Performance Improved" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Restless" on the Visual Analog Scale	Subjects rated their feelings of "Restless" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Rush" on the Visual Analog Scale	Subjects rated their feelings of "Rush" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Shaky, Jittery" on the Visual Analog Scale	Subjects rated their feelings of "Shaky, Jittery" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Sluggish, Fatigued, Lazy" on the Visual Analog Scale	Subjects rated their feelings of "Sluggish, Fatigued, Lazy" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Stimulated" on the Visual Analog Scale	Subjects rated their feelings of "Stimulated" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Willing to Take Again" on the Visual Analog Scale	Subjects rated their feelings of "Willing to Take Again" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Ratings of "Talkative, Friendly" on the Visual Analog Scale	Subjects rated their feelings of "Talkative, Friendly" on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Oral Temperature	Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Diastolic Blood Pressure	Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes
Secondary	Peak Heart Rate	Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.	This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.	Yes