Impact of Buspirone Maintenance on the Reinforcing Effects of Cocaine

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cocaine Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Buspirone

Subjects will be maintained on 30 mg buspirone daily.

Group Type EXPERIMENTAL

Buspirone

Intervention Type DRUG

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 placebo (i.e., 0 mg buspirone daily).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Buspirone

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes