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Nicotinic Receptor Agonist

Dual Use Cessation for Smoking

Phase 4
Recruiting
Led By Megan E Piper, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and medically able to use varenicline and nicotine patches
Be older than 18 years old
Must not have
Currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)
Currently in treatment for psychosis or bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to find the best way to help people who smoke both cigarettes and e-cigarettes quit smoking. They will enroll 500 participants who will be in the study for 12 months.

Who is the study for?
This trial is for individuals who use both cigarettes and electronic nicotine delivery systems (ENDS) and are looking to quit. Participants will be involved in the study for 12 months.
What is being tested?
The study aims to find the best way to help dual users of cigarettes and ENDS quit smoking by comparing different cessation methods: Dual Focused Cessation Counseling, Varenicline with a single session, Nicotine patch, or Smoking Focused Cessation Counseling with four sessions.
What are the potential side effects?
Possible side effects may include nausea, sleep disturbances, skin reactions at the patch site, headaches, and unusual dreams typically associated with quitting smoking aids like Varenicline and nicotine patches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing and can safely use varenicline and nicotine patches.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking bupropion for reasons other than to quit smoking.
Select...
I am currently receiving treatment for psychosis or bipolar disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
52-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes
Secondary study objectives
26-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes
7-day point-prevalence abstinence from smoking and vaping at Weeks 26 and 52 post-TQD
Other study objectives
12-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes
7-day point-prevalence abstinence from smoking and vaping at Week 12
Number of Participants Achieving Initial Abstinence from Smoking and Vaping
+3 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

8Treatment groups
Active Control
Group I: Nicotine Patches, Dual Focused, 1 sessionActive Control3 Interventions
Group II: Varenicline, Smoking Focused, 4 sessionsActive Control3 Interventions
Group III: Varenicline, Dual Focused, 1 sessionActive Control3 Interventions
Group IV: Nicotine Patches, Dual Focused, 4 sessionsActive Control3 Interventions
Group V: Nicotine Patches, Smoking Focused, 4 sessionsActive Control3 Interventions
Group VI: Varenicline, Dual Focused, 4 sessionsActive Control3 Interventions
Group VII: Varenicline, Smoking Focused, 1 sessionActive Control3 Interventions
Group VIII: Nicotine Patches, Smoking Focused, 1 sessionActive Control3 Interventions

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,538 Total Patients Enrolled
5 Trials studying Vaping
3,377 Patients Enrolled for Vaping
University of Wisconsin, MadisonLead Sponsor
1,231 Previous Clinical Trials
3,199,385 Total Patients Enrolled
Megan E Piper, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
4 Previous Clinical Trials
1,391 Total Patients Enrolled
~333 spots leftby Jul 2028
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