Psychopharmacology for Cocaine Dependence - Buspirone

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.

Conditions

• Cocaine Dependence

Interventions

DRUG

Buspirone

\[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday\] \[weeks 2-3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday\]

DRUG

Placebo for Buspirone

\[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday\] \[weeks 2-3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday\]

DRUG

Methylphenidate

Methylphenidate serves as an acute stimulant challenge. \[week 1: no Methylphenidate or Methylphenidate placebo\] \[week 2: 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]

DRUG

Placebo for Methylphenidate

\[week 1: no Methylphenidate or Methylphenidate placebo\] \[week 2: 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\] \[week 3: Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)\]

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston

  lead OTHER

Principal Investigators

• Scott D Lane, Ph.D. · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2015-12-31

Completion

2015-12-31

FDA Drug

Yes

Countries

• United States

Study Locations