A Phase 1/2 interventional study of Buspirone and Placebo in Smoking Cessation and Tobacco Use Cessation, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-04.
Sponsored by Centre for Addiction and Mental Health · Phase 1/2, Interventional, and Basic science
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.
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.
350 studies on the registry are indexed under Smoking Cessation; 145 are open to participants now.
This study's enrollment of 6 is below the median of 150 across 326 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →Centre for Addiction and Mental Health is the lead sponsor of 339 studies on the registry; 51 are open to participants now.
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- 19 years or older
Exclusion Criteria:
Buspirone 120 mg (encapsulated).
Drug: Buspirone
Buspirone 60 mg (encapsulated)
Drug: Buspirone
Placebo (encapsulated)
Drug: Placebo
Buspirone 30 mg (encapsulated).
Drug: Buspirone
The buspirone will be given once as a tablet and encapsulated for blinding.
Also known as: Buspar
Placebo will be lactose and encapsulated for blinding. A single capsule will be given.
Also known as: lactose
Dose-response occupancy of buspirone at DRD3
\[11C\]-(+)-PHNO binding potential at three doses of buspirone and placebo.
Time frame: few months
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Buspirone
Centre for Addiction and Mental Health →