Smoking CessationPhase 1/2NCT01699828
Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET
A Phase 1/2 study testing Buspirone in people with Smoking Cessation and Tobacco Use Cessation, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Use Cessation
- What is being tested?
- Buspirone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Jun 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 years or older
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation, Tobacco Use Cessation
- Being tested
- Buspirone, Placebo
- Keywords
- buspirone, smoking cessation, dopamine, PET imaging, [11C]-(+)-PHNO
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
Also called Buspar
The buspirone will be given once as a tablet and encapsulated for blinding.
PlaceboDrug
Also called lactose
Placebo will be lactose and encapsulated for blinding. A single capsule will be given.
| Study group | Role | What they receive |
|---|---|---|
| Buspirone 120 mg | Experimental | Buspirone 120 mg (encapsulated). Receives: Drug: Buspirone |
| Buspirone 60 mg | Experimental | Buspirone 60 mg (encapsulated) Receives: Drug: Buspirone |
| Placebo | Placebo comparator | Placebo (encapsulated) Receives: Drug: Placebo |
| Buspirone 30 mg | Experimental | Buspirone 30 mg (encapsulated). Receives: Drug: Buspirone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-response occupancy of buspirone at DRD3
[11C]-(+)-PHNO binding potential at three doses of buspirone and placebo.
Measured: few months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Le Foll, Centre for Addiction and Mental Health
- Investigators
- Isabelle Boileau, PhD, Principal investigator, Center for Addiction and Mental HealthBernard Le Foll, MD, PhD, Principal investigator, Center for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699828
- Sponsor's protocol ID
- 186/2011
- Status last verified
- Jun 2014
- First submitted
- 2 Oct 2012
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET
- ClinicalTrials.gov ID
- NCT01699828
- Acronym / sponsor ID
- 186/2011
- Conditions
- Smoking Cessation, Tobacco Use Cessation
- Keywords
- buspirone, smoking cessation, dopamine, PET imaging, [11C]-(+)-PHNO
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Buspirone 120 mg | Experimental | Drug: BuspironeBuspirone 120 mg (encapsulated). |
| Buspirone 60 mg | Experimental | Drug: BuspironeBuspirone 60 mg (encapsulated) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (encapsulated) |
| Buspirone 30 mg | Experimental | Drug: BuspironeBuspirone 30 mg (encapsulated). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 19 years or older
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuspironeAlso: BusparThe buspirone will be given once as a tablet and encapsulated for blinding. | Drug | Buspirone 120 mg, Buspirone 30 mg, Buspirone 60 mg |
| PlaceboAlso: lactosePlacebo will be lactose and encapsulated for blinding. A single capsule will be given. | Drug | Placebo |
Primary outcome
Dose-response occupancy of buspirone at DRD3
Time frame: few months
[11C]-(+)-PHNO binding potential at three doses of buspirone and placebo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teachingLink provided by the sponsor.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Boileau, PhD principal investigator
Center for Addiction and Mental Health
Bernard Le Foll, MD, PhD principal investigator
Center for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Buspirone in people with Smoking Cessation and Tobacco Use Cessation, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-response occupancy of buspirone at DRD3 (time frame: few months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014.