Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

Status Completed

Clinical Trial Summary

The lack of proven waterpipe smoking cessation interventions makes it important to explore interventions proven effective for cigarette smoking cessation. The investigators hypothesize that Varenicline (Chantix) administrated for 12 weeks is associated with higher sustained quit rate at 12 weeks compared to placebo. The investigators propose to conduct a randomized double-blind placebo-controlled trial that will evaluate the effect of Varenicline (Chantix), in two parallel groups each consisting of 76 habitual waterpipe smokers who are willing to quit. Potential participants will be approached in cafés, word-of-mouth and through media and will be invited to the American University of Beirut Medical Center to complete study procedures. Both study groups will receive the same behavioural intervention in combination with either Varenicline (Chantix), an FDA approved drug indicated for use as an aid to smoking cessation treatment, or placebo. Participants will complete study procedures in four visits. During visit-1 the informed consent process, baseline assessments and randomization will be completed and Varenicline (Chantix) or Placebo will be initiated together with the behavioural interventions. The behavioural intervention will be continued over the next 2 visits. An end of treatment visit 12 weeks after quit date will be dedicated to assessing sustained quit rate and other outcomes.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02575183
Study type	Interventional
Source	American University of Beirut Medical Center
Contact
Status	Completed
Phase	Phase 4
Start date	August 31, 2016
Completion date	March 1, 2021

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Withdrawn	`NCT03707600` - State and Trait Mediated Response to TMS in Substance Use Disorder	N/A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
Completed	`NCT01632189` - The Effect of Varenicline on D2/D3 Receptor Binding in Smokers	N/A
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	`NCT00996034` - Nicotine Vaccination and Nicotinic Receptor Occupancy	Phase 2
Completed	`NCT01061528` - Coping Skills Treatment for Smoking Cessation	N/A
Suspended	`NCT01636336` - Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects	N/A
Withdrawn	`NCT01589081` - Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect	N/A
Completed	`NCT01943994` - Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study	N/A