NCT01632189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

2.9 years

First QC Date

June 28, 2012

Last Update Submit

January 26, 2016

Conditions

Nicotine Dependence

Keywords

VareniclinePET imaging[11C]-(+)-PHNO PETneuroimaging in smokers

Outcome Measures

Primary Outcomes (1)

  • [11C]-(+)-PHNO DRD2/3 binding potential (BPND)

    The effects of chronic administration of varenicline (standard dose run up protocol to 2 mg per day for 10 days) vs. baseline on \[11C\]-(+)-PHNO binding in human brain of tobacco smokers (12 hours abstinent).

    10 days

Secondary Outcomes (1)

  • Relationship between ability to quit smoking and changes in DRD2/3

    6 months

Study Arms (1)

Varenicline

EXPERIMENTAL

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.

Drug: Varenicline

Interventions

VareniclineDRUG

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.

Also known as: Champix
Varenicline

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26442600RESULT

Related Links

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Bernard Le Foll, MD, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; MD, PhD, CCFP

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 2, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

CA(1)