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Alternative Nicotine Delivery System
Juul Electronic cigarette for Nicotine Addiction
Phase 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the two 1-week switching periods
Awards & highlights
Study Summary
This trial will study the effect of two FDA strategies to reduce smoking: providing low-nicotine cigarettes and safe alternative nicotine delivery systems.
Eligible Conditions
- Nicotine Addiction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the two 1-week switching periods
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the two 1-week switching periods
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean Number of Conventional Cigarettes Smoked During Each Switch Week
Secondary outcome measures
Mean Number of VLNCs Smoked or Vape Events Per Day Reported During Each Switch Week
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: No Product + Placebo Patch in Wk 1 and Active Patch in Wk 2Experimental Treatment2 Interventions
Participants will be given no alternative nicotine delivery products for two weeks but in Switch Week 1 participants will use placebo patches; in Switch Week 2, participants will use active nicotine patches.
Group II: No Product + Active Patch in Wk 1 and Placebo Patch in Wk 2Experimental Treatment2 Interventions
Participants will be given no alternative nicotine delivery products but in Switch Week 1, participants will use active nicotine patches; in Switch Week 2, participants will use placebo patches.
Group III: Juul + Active Patch in Wk 1 and Placebo Patch in Wk 2Active Control3 Interventions
Participants will be given Juul e-cigarettes for four weeks; in Switch Week 1, participants also will use active nicotine patches; in Switch Week 2, participants will use placebo patches.
Group IV: Juul + Placebo Patch in Wk 1 and Active Patch in Wk 2Active Control3 Interventions
Participants will be given Juul e-cigarettes for four weeks; in Switch Week 1, participants also will use placebo patches; in Switch Week 2, participants will use active nicotine patches.
Group V: VLNC + Active Patch in Wk 1 and Placebo Patch in Wk 2Active Control3 Interventions
Participants will be given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1, participants also will use active nicotine patches; in Switch Week 2, participants will use placebo patches.
Group VI: VLNC + Placebo Patch in Wk 1 and Active Patch in Wk 2Active Control3 Interventions
Participants will be given very low nicotine cigarettes (VLNCs) for four weeks; in Switch Week 1, participants also will use placebo patches; in Switch Week 2, participants will use active nicotine patches.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active Nicotine Patch
2020
Completed Phase 2
~210
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,178 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,114 Total Patients Enrolled
1 Trials studying Nicotine Addiction
20 Patients Enrolled for Nicotine Addiction
Megan E Piper, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
3 Previous Clinical Trials
1,261 Total Patients Enrolled
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