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

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Collaborators: Ontario Lung Association; Pfizer
• Treatments: Varenicline

Criteria

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