The Effect of Varenicline on D2/D3 Receptor Binding in Smokers

NCT01632189

Last updated date
Study Location
Centre for Addiction and Mental Health
Toronto, Ontario, , Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nicotine Dependence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects will be nicotine dependent, males and females of any ethnic origin between 21 and 45 years old.

- Meet DSM-IV criteria for nicotine dependence,

- Smoke ≥10 cigarettes/day, Baseline FTND score ≥4, CO level ≥10 and are motivated to quit within 30 days of initial intake.

- Treatment seeking smokers that are willing to use varenicline as a treatment approach for their smoking cessation attempt

- No previous use of medication for smoking cessation in previous month prior inclusion.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnancy (a urine pregnancy test will be performed before each PET in women)


- Trying to become pregnant or breastfeeding;


- Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc)
in 3 months prior to randomization.


- Presence of metal objects in the body (e.g. some artificial joints, bone pins,
surgical clips, skull plate, certain part of dental braces) or implanted electronic
devices (e.g. cardiac pacemaker, neurostimulator), that preclude safe MR scanning.


- Claustrophobia.


- Cardiovascular or cerebrovascular diseases.


- Major psychiatric disorders including mood, anxiety or psychotic disorders with
historical evidence of suicidal or homicidal behaviour.


- History of or current neurological illnesses including seizure disorders, migraine,
multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor. Gross
structural brain abnormalities as revealed by T1 weighted images.


- Current use or use during the previous month of medication that may affect the CNS at
the time of scanning (including illicit and non-illicit psychoactive drugs).


- Learning disability, amnesia or other conditions that impede memory and attention.


- Allergy to varenicline.


- Renal insufficiency.


- Use of other smoking cessation aids

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Advanced Information
Descriptive Information
Brief Title  ICMJE The Effect of Varenicline on D2/D3 Receptor Binding in Smokers
Official Title  ICMJE Investigating the Effects of Varenicline on D2/3 Receptor Binding in Brain of Tobacco-smokers: a PET/[11C](+)PHNO Study
Brief Summary This study will evaluate effects of treatment with varenicline, a smoking cessation drug, on the dopaminergic system by using Positron Emission Tomography (PET) imaging with new radioligand, [11C]-(+)-PHNO. The investigators primary hypothesis is that chronic varenicline administration will increase dopamine (DA) receptors levels ([11C](+)PHNO) within the human brain.
Detailed Description Subjects will undergo a pre-treatment PET and MRI scans for baseline [11C](+)PHNO measures on Day 1. Subjects will subsequently be provided an initial 2-week supply of study medications (varenicline) and directions for use. Any adverse events, compliance to medication and smoking patterns will be noted during these two weeks. Varenicline will be used at the same dosage regimen as used for smoking cessation. After subjects go through a post-treatment PET and MRI scans on Day 10, they will be instructed to set up a quit date. There will then be follow-up visits every 2 weeks for the duration of the medication phase (3 months total) and a visit at 6 months follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE Drug: Varenicline
Varenicline will be administered as prescribed: 0.5 mg for the first 3 days then 1 mg for the next 7 days and 2 mg after that. A quit date will be chosen at 11 days after starting Varenicline. Varenicline will be given for 3 months.
Other Name: Champix
Study Arms  ICMJE Experimental: Varenicline
Varenicline will be used at the same dosage regimen as used for smoking cessation, i.e. 0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily. The total duration of Varenicline treatment will be three months.
Intervention: Drug: Varenicline
Publications * Di Ciano P, Guranda M, Lagzdins D, Tyndale RF, Gamaleddin I, Selby P, Boileau I, Le Foll B. Varenicline-Induced Elevation of Dopamine in Smokers: A Preliminary [(11)C]-(+)-PHNO PET Study. Neuropsychopharmacology. 2016 May;41(6):1513-20. doi: 10.1038/npp.2015.305. Epub 2015 Oct 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2012)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects will be nicotine dependent, males and females of any ethnic origin between 21 and 45 years old.
  • Meet DSM-IV criteria for nicotine dependence,
  • Smoke ?10 cigarettes/day, Baseline FTND score ?4, CO level ?10 and are motivated to quit within 30 days of initial intake.
  • Treatment seeking smokers that are willing to use varenicline as a treatment approach for their smoking cessation attempt
  • No previous use of medication for smoking cessation in previous month prior inclusion.

Exclusion Criteria:

  • Pregnancy (a urine pregnancy test will be performed before each PET in women)
  • Trying to become pregnant or breastfeeding;
  • Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 3 months prior to randomization.
  • Presence of metal objects in the body (e.g. some artificial joints, bone pins, surgical clips, skull plate, certain part of dental braces) or implanted electronic devices (e.g. cardiac pacemaker, neurostimulator), that preclude safe MR scanning.
  • Claustrophobia.
  • Cardiovascular or cerebrovascular diseases.
  • Major psychiatric disorders including mood, anxiety or psychotic disorders with historical evidence of suicidal or homicidal behaviour.
  • History of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor. Gross structural brain abnormalities as revealed by T1 weighted images.
  • Current use or use during the previous month of medication that may affect the CNS at the time of scanning (including illicit and non-illicit psychoactive drugs).
  • Learning disability, amnesia or other conditions that impede memory and attention.
  • Allergy to varenicline.
  • Renal insufficiency.
  • Use of other smoking cessation aids
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01632189
Other Study ID Numbers  ICMJE 040/2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bernard Le Foll, Centre for Addiction and Mental Health
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE
  • Ontario Lung Association
  • Pfizer
Investigators  ICMJE
Principal Investigator:Bernard Le Foll, MD, PhDCentre for Addiction and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date January 2016

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