Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-06-30

Brief Summary

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The objective of the present study is to use positron emission tomography brain imaging to investigate D3 occupancy of buspirone, an FDA-approved anxiolytic which acts as a serotonin partial agonist but has recently been identified as a D3 antagonist. It is hypothesized that clinically relevant doses of buspirone will occupy the D3 receptor.

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Detailed Description

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Buspirone is used for anxiety disorder treatment, a therapeutic effect that has been thought to be mediated through its partial agonist properties at the serotonin receptor. However, since one PET study in humans has shown low occupancy of the serotonin by buspirone in clinical doses and since the DRD3 has been recently implicated in anxiety, some therapeutic effects of buspirone may be mediated through the DRD3. In human clinical studies, promising effects of buspirone have been reported for treatment of substance dependence, including tobacco, marijuana, and opiates, and clinical studies in cocaine dependent subjects are underway. However, it is unclear if buspirone is producing those effects through the DRD3 and no human study has incorporated a PET imaging component to investigate this question; it remains unclear whether buspirone significantly occupies the DRD3 at therapeutic doses in humans.

Conditions

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Smoking Cessation Tobacco Use Cessation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Buspirone 120 mg

Buspirone 120 mg (encapsulated).

Group Type EXPERIMENTAL

Buspirone

Intervention Type DRUG

The buspirone will be given once as a tablet and encapsulated for blinding.

Buspirone 60 mg

Buspirone 60 mg (encapsulated)

Group Type EXPERIMENTAL

Buspirone

Intervention Type DRUG

The buspirone will be given once as a tablet and encapsulated for blinding.

Placebo

Placebo (encapsulated)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be lactose and encapsulated for blinding. A single capsule will be given.

Buspirone 30 mg

Buspirone 30 mg (encapsulated).

Group Type EXPERIMENTAL

Buspirone

Intervention Type DRUG

The buspirone will be given once as a tablet and encapsulated for blinding.

Interventions

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Buspirone

The buspirone will be given once as a tablet and encapsulated for blinding.

Intervention Type DRUG

Placebo

Placebo will be lactose and encapsulated for blinding. A single capsule will be given.

Intervention Type DRUG

Other Intervention Names

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Buspar lactose

Eligibility Criteria

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Inclusion Criteria

\- 19 years or older

Exclusion Criteria

* Medical condition including cardiovascular, renal, hepatic or cerebrovascular diseases
* History of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor, - Present or past psychiatric condition including mood, anxiety, psychotic disorders and substance abuse and/or dependence.
* Condition that precludes use of buspirone or that will interfere with participation in the present study (such as hypersensitive to buspirone hydrochloride).
* Pregnancy or breastfeeding.
* Presence of metal objects in the body or implanted electronic devices, that preclude safe MR scanning.
* Claustrophobia.
* Current use or use during the previous month of medication that may affect the CNS, including monoamine oxidase inhibitor (MAOI) or positive during drug screening for drugs of abuse or any medication that could increase the risk of buspirone administration.
* Exposure to radiation in the last 12 month exceeding permissible limit for subjects participating in research.

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes