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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01699828
Other study ID # 186/2011
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received October 2, 2012
Last updated June 3, 2014
Start date October 2012
Est. completion date June 2014

Study information

Verified date June 2014
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 65 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Buspirone
The buspirone will be given once as a tablet and encapsulated for blinding.
Placebo
Placebo will be lactose and encapsulated for blinding. A single capsule will be given.

Locations

Country Name City State
Canada Center for Addiction and Mental Health Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-response occupancy of buspirone at DRD3 [11C]-(+)-PHNO binding potential at three doses of buspirone and placebo. few months No
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