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:
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: January 9, 2014
Last verified: June 2013

October 2, 2012
January 9, 2014
October 2012
June 2014   (final data collection date for primary outcome measure)
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.
Dose-response occupancy of buspirone at DRD3 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
[11C]-(+)-PHNO binding potential at three doses of buspirone and placebo.
Complete list of historical versions of study NCT01699828 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET
Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Smoking Cessation
  • Tobacco Use Cessation
  • Drug: Buspirone
    The buspirone will be given once as a tablet and encapsulated for blinding.
    Other Name: Buspar
  • Drug: Placebo
    Placebo will be lactose and encapsulated for blinding. A single capsule will be given.
    Other Name: lactose
  • Experimental: Buspirone 120 mg
    Buspirone 120 mg (encapsulated).
    Intervention: Drug: Buspirone
  • Experimental: Buspirone 60 mg
    Buspirone 60 mg (encapsulated)
    Intervention: Drug: Buspirone
  • Placebo Comparator: Placebo
    Placebo (encapsulated)
    Intervention: Drug: Placebo
  • Experimental: Buspirone 30 mg
    Buspirone 30 mg (encapsulated).
    Intervention: Drug: Buspirone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
19 Years to 65 Years
Yes
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
Canada
 
NCT01699828
186/2011
No
Bernard Le Foll, Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
Not Provided
Principal Investigator: Isabelle Boileau, PhD Center for Addiction and Mental Health
Principal Investigator: Bernard Le Foll, MD, PhD Center for Addiction and Mental Health
Centre for Addiction and Mental Health
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP