Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET
Information source: Centre for Addiction and Mental Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Smoking Cessation; Tobacco Use Cessation
Intervention: Buspirone (Drug); Placebo (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Centre for Addiction and Mental Health Official(s) and/or principal investigator(s): Isabelle Boileau, PhD, Principal Investigator, Affiliation: Center for Addiction and Mental Health Bernard Le Foll, MD, PhD, Principal Investigator, Affiliation: Center for Addiction and Mental Health
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.
Clinical Details
Official title: Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Dose-response occupancy of buspirone at DRD3
Detailed 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.
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Center for Addiction and Mental Health, Toronto, Ontario M5S 2S1, Canada
Additional Information
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching
Starting date: October 2012
Last updated: June 3, 2014
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