Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine

NCT01639157 | Completed Results

• 1 other identifier: R21DA034095-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Use Disorders

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 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 buspirone and placebo maintenance conditions.

• Peak Systolic Blood Pressure

  This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone 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 buspirone 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 buspirone 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 buspirone and placebo maintenance conditions.

Study Arms (2)

Buspirone

EXPERIMENTAL

Subjects will be maintained on 30 mg buspirone daily.

Drug: Buspirone

Placebo

PLACEBO COMPARATOR

Subjects will be maintained on placebo (i.e., 0 mg buspirone daily).

Drug: Placebo

Interventions

Buspirone DRUG

Subjects will be maintained on oral buspirone (10 mg administered 3 times daily) for 6 days each during the study in random order.

Buspirone

Placebo DRUG

Subjects will be maintained on oral placebo (0 mg administered 3 times daily) for 6 days each during the study in random order.

Placebo

Eligibility Criteria

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

You may qualify if:

• Recent cocaine use

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 buspirone

Sponsors & Collaborators

• William Stoops: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Related 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.

  PMID: 20638380 BACKGROUND

MeSH Terms

Interventions

Buspirone

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Results Point of Contact

• Title: William W. Stoops, Ph.D.
• Organization: University of Kentucky

william.stoops@uky.edu

859-257-5388

Study Officials

• William W Stoops, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 12, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 19, 2016
• Results First Posted: February 19, 2016

Record last verified: 2016-01

Locations

US (1)