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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Nicotine Dependence

Clinical Trial Details

NCT number	NCT01632189
Study type	Interventional
Source	Centre for Addiction and Mental Health
Contact
Status	Completed
Phase	N/A
Start date	September 2012
Completion date	August 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05176418` - IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate	Early Phase 1
Completed	`NCT04084210` - Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use	Phase 2
Completed	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Withdrawn	`NCT03707600` - State and Trait Mediated Response to TMS in Substance Use Disorder	N/A
Recruiting	`NCT03999099` - Targeting Orexin to Treat Nicotine Dependence	Phase 1
Completed	`NCT03847155` - Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery	N/A
Completed	`NCT02840435` - Study on Sit to Quit Phone Intervention	N/A
Completed	`NCT02139930` - Project 2: Strategies for Reducing Nicotine Content in Cigarettes	N/A
Completed	`NCT01982110` - A Mindfulness Based Application for Smoking Cessation	N/A
Completed	`NCT01926626` - Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers	Phase 2
Completed	`NCT01685996` - Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation	Phase 1/Phase 2
Withdrawn	`NCT01569477` - Striving to Quit-Wisconsin Tobacco Quit Line	N/A
Completed	`NCT01569490` - Striving to Quit: First Breath	N/A
Active, not recruiting	`NCT01182766` - New Treatment for Alcohol and Nicotine Dependence	Phase 2/Phase 3
Completed	`NCT01061528` - Coping Skills Treatment for Smoking Cessation	N/A
Completed	`NCT00996034` - Nicotine Vaccination and Nicotinic Receptor Occupancy	Phase 2
Completed	`NCT01943994` - Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study	N/A
Withdrawn	`NCT01589081` - Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect	N/A
Suspended	`NCT01636336` - Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects	N/A
Withdrawn	`NCT00571805` - Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt	Phase 1/Phase 2