NCT01632189

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

Investigating the Effects of Varenicline on D2/3 Receptor Binding in Brain of Tobacco-smokers: a PET/[11C](+)PHNO Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2012-07-02
• Last updated: 2016-01-27

Locations

1 site across 1 country: Canada