Varenicline for Hypersensitivity

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Hypersensitivity+1 More
Varenicline - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if varenicline or the nicotine patch can help people with different emotional and attention levels quit smoking.

Eligible Conditions
  • Hypersensitivity
  • Tobacco

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 3 months

3 months
Continuous and Prolonged Nicotine Abstinence
8 weeks
Continuous Nicotine Abstinence

Trial Safety

Side Effects for

Varenicline
17%Abnormal/Vivid Dreams
17%Dry Mouth
17%Nausea/Vomiting
17%Constipation
17%Dizziness/Lightheadedness
17%Asthma flare
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04089982) in the Varenicline ARM group. Side effects include: Abnormal/Vivid Dreams with 17%, Dry Mouth with 17%, Nausea/Vomiting with 17%, Constipation with 17%, Dizziness/Lightheadedness with 17%.

Trial Design

2 Treatment Groups

Nicotine Patch + Placebo Tablet
1 of 2
Varenicline + Placebo Patch
1 of 2
Experimental Treatment

204 Total Participants · 2 Treatment Groups

Primary Treatment: Varenicline · Has Placebo Group · Phase 4

Nicotine Patch + Placebo TabletExperimental Group · 6 Interventions: Nicotine Patch, Lab Session, Placebo Tablet, Saliva Test, Counseling Sessions, Questionnaires · Intervention Types: Drug, Other, Drug, Other, Behavioral, Behavioral
Varenicline + Placebo PatchExperimental Group · 6 Interventions: Varenicline, Placebo Patch, Lab Session, Saliva Test, Counseling Sessions, Questionnaires · Intervention Types: Drug, Drug, Other, Other, Behavioral, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
FDA approved
Nicotine
FDA approved
Placebo Patch
2011
Completed Phase 4
~4500
Placebo Tablet
2016
Completed Phase 3
~3280
Counseling Sessions
2006
Completed Phase 2
~460
Questionnaires
2013
Completed Phase 2
~3240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

PfizerIndustry Sponsor
4,260 Previous Clinical Trials
7,104,761 Total Patients Enrolled
6 Trials studying Hypersensitivity
382,540 Patients Enrolled for Hypersensitivity
NAL PHARMAOTHER
M.D. Anderson Cancer CenterLead Sponsor
2,779 Previous Clinical Trials
1,784,559 Total Patients Enrolled
Paul Cinciripini, PHD, MS, BSPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
795 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: October 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.