Psychopharmacology for Cocaine Dependence - Buspirone

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic cocaine use may produce disruption of neurotransmitter functions (including dopamine). This may in turn contribute to measurable dysfunction in important cognitive and behavioral processes. Stimulants that enhance dopamine (DA) function may help in treating cocaine dependence and improving behavioral function -- supporting the notion that these processes are related. An important step is to understand the subjective, physiological, and behavioral effects of potential medications for cocaine dependence.

DA-modulating drugs may be targets for pharmacotherapy for substance dependence, and particularly for stimulant drugs like cocaine, which disrupt normal DA function. Buspirone is currently the only available dopamine subtype 3 (DA3) approved for human administration, and is thus a viable investigational compound.

This project proposes to evaluate the DA-modulating effects of buspirone on behavioral deficiencies related to DA depletion. Accordingly, the project aims to characterize the effects of buspirone in individuals with cocaine dependence. Employing a daily dosing designs within an acute stimulant challenge (methylphenidate), the experiment will characterize the subjective effects, cardiovascular effects, and behavioral effects (attentional bias to drug cues and risky decision making). The primary hypotheses are that buspirone will attenuate the increases in subjective drug effects ("stimulated", "like drug") and behavioral effects (increases in attentional bias and risky decision making) that are produced by acute methylphenidate administration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Buspirone; Cocaine; Methylphenidate

Criteria

Inclusion Criteria:

• cocaine dependent subjects, non-treatment seeking

• meet current DSM-IV criteria for cocaine dependence disorder

• report using cocaine within the past 30 days

• at least 1 positive urine toxicology screen for the cocaine metabolite benzoylecgonine (BE) [300 ng/mL, during the initial (2-4 day) screening period

• acceptable health on the basis of interview, medical history, and physical exam

• able to understand the consent form and provide written informed consent.

Exclusion Criteria:

• currently dependent on any psychoactive substance other than cocaine or nicotine

• current DSM-IV diagnosed major psychiatric disorder (e.g., psychosis, bipolar, major depressive disorder)

• any medical condition that would contraindicate administration of medications

• taking medications known to have significant drug interactions study medications

• probation / parole requiring reports of drug use to court officers

• pregnant or nursing for female patients

• cannot read, write, or speak English.