Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Buspirone

+ Buspirone

+ Placebo

Drug
Who is being recruted

Behavior+1

+ Health Behavior

+ Smoking Cessation

From 19 to 65 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorCentre for Addiction and Mental Health
Last updated: June 4, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorCentre for Addiction and Mental Health
Last updated: June 4, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorHealth BehaviorSmoking CessationTobacco Use Cessation

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Buspirone 120 mg (encapsulated).

Group II

Experimental
Buspirone 60 mg (encapsulated)

Group III

Placebo
Placebo (encapsulated)

Group IV

Experimental
Buspirone 30 mg (encapsulated).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Center for Addiction and Mental Health

Toronto, CanadaOpen Center for Addiction and Mental Health in Google Maps
CompletedOne Study Center