NCT01699828

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

1.7 years

First QC Date

October 2, 2012

Last Update Submit

June 3, 2014

Conditions

Smoking CessationTobacco Use Cessation

Keywords

buspironesmoking cessationdopaminePET imaging[11C]-(+)-PHNO

Outcome Measures

Primary Outcomes (1)

  • Dose-response occupancy of buspirone at DRD3

    \[11C\]-(+)-PHNO binding potential at three doses of buspirone and placebo.

    few months

Study Arms (4)

Buspirone 120 mg

EXPERIMENTAL

Buspirone 120 mg (encapsulated).

Drug: Buspirone

Buspirone 60 mg

EXPERIMENTAL

Buspirone 60 mg (encapsulated)

Drug: Buspirone

Placebo

PLACEBO COMPARATOR

Placebo (encapsulated)

Drug: Placebo

Buspirone 30 mg

EXPERIMENTAL

Buspirone 30 mg (encapsulated).

Drug: Buspirone

Interventions

BuspironeDRUG

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

Also known as: Buspar
Buspirone 120 mgBuspirone 30 mgBuspirone 60 mg
PlaceboDRUG

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

Also known as: lactose
Placebo

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 19 years or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Links

MeSH Terms

Conditions

Smoking CessationTobacco Use Cessation

Interventions

BuspironeLactose

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Spiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPolycyclic CompoundsDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Isabelle Boileau, PhD

    Center for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

  • Bernard Le Foll, MD, PhD

    Center for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

October 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 4, 2014

Record last verified: 2014-06

Locations

CA(1)