Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET
This study is currently recruiting participants.
Verified June 2013 by Centre for Addiction and Mental Health
Sponsor:
Centre for Addiction and Mental Health
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01699828
First received: October 2, 2012
Last updated: June 17, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking Cessation Tobacco Use Cessation |
Drug: Buspirone Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET |
Resource links provided by NLM:
Further study details as provided by Centre for Addiction and Mental Health:
Primary Outcome Measures:
- Dose-response occupancy of buspirone at DRD3 [ Time Frame: few months ] [ Designated as safety issue: No ][11C]-(+)-PHNO binding potential at three doses of buspirone and placebo.
| Estimated Enrollment: | 6 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Buspirone 120 mg
Buspirone 120 mg (encapsulated).
|
Drug: Buspirone
The buspirone will be given once as a tablet and encapsulated for blinding.
Other Name: Buspar
|
|
Experimental: Buspirone 60 mg
Buspirone 60 mg (encapsulated)
|
Drug: Buspirone
The buspirone will be given once as a tablet and encapsulated for blinding.
Other Name: Buspar
|
|
Placebo Comparator: Placebo
Placebo (encapsulated)
|
Drug: Placebo
Placebo will be lactose and encapsulated for blinding. A single capsule will be given.
Other Name: Buspar
|
|
Experimental: Buspirone 30 mg
Buspirone 30 mg (encapsulated).
|
Drug: Buspirone
The buspirone will be given once as a tablet and encapsulated for blinding.
Other Name: Buspar
|
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| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699828
Contacts
| Contact: Bernard Le Foll, MD, PhD | 416-535-8501 ext 4772 | bernard.lefoll@camh.ca |
| Contact: Isabelle Boileau, PhD | 416-535-8501 ext 4918 | Isabelle.Boileau@camh.ca |
Locations
| Canada, Ontario | |
| Center for Addiction and Mental Health | Recruiting |
| Toronto, Ontario, Canada, M5S 2S1 | |
| Contact: Bernard Le Foll, MD, PhD 416-535-8501 ext 4772 bernard.lefoll@camh.ca | |
| Contact: Isabelle Boileau, PhD 416-535-8501 ext 4918 Isabelle.Boileau@camh.ca | |
| Sub-Investigator: Alan Wilson, PhD | |
| Sub-Investigator: Sylvain Houle, MD, PhD | |
| Sub-Investigator: Ariel Graff, MD, PhD | |
| Principal Investigator: Isabelle Boileau, PhD | |
| Principal Investigator: Bernard Le Foll, MD, PhD | |
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
| Principal Investigator: | Isabelle Boileau, PhD | Center for Addiction and Mental Health |
| Principal Investigator: | Bernard Le Foll, MD, PhD | Center for Addiction and Mental Health |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bernard Le Foll, PI, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT01699828 History of Changes |
| Other Study ID Numbers: | 186/2011 |
| Study First Received: | October 2, 2012 |
| Last Updated: | June 17, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Centre for Addiction and Mental Health:
|
buspirone smoking cessation dopamine PET imaging [11C]-(+)-PHNO |
Additional relevant MeSH terms:
|
Smoking Habits Buspirone Dopamine Dopamine Agents Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Anxiety Agents |
Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Cardiotonic Agents Cardiovascular Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Protective Agents |
ClinicalTrials.gov processed this record on June 18, 2013