The Effect of Varenicline on D2/D3 Receptor Binding in Smokers
|ClinicalTrials.gov Identifier: NCT01632189|
Recruitment Status : Completed
First Posted : July 2, 2012
Last Update Posted : January 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: Varenicline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Investigating the Effects of Varenicline on D2/3 Receptor Binding in Brain of Tobacco-smokers: a PET/[11C](+)PHNO Study|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
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.
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
- [11C]-(+)-PHNO DRD2/3 binding potential (BPND) [ Time Frame: 10 days ]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).
- Relationship between ability to quit smoking and changes in DRD2/3 [ Time Frame: 6 months ]Relationship between clinical ratings of abstinence and cravings and DRD2/3 normalization after 10-day course of varenicline administration.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632189
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada|
|Principal Investigator:||Bernard Le Foll, MD, PhD||Centre for Addiction and Mental Health|