The Effect of Varenicline on D2/D3 Receptor Binding in Smokers
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|