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Nicotine Replacement Therapy
Very Low Nicotine Content (VLNC) Cigarettes for Smoking Cessation
Phase 2
Waitlist Available
Led By Vani Simmons, Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
smoke at least 5 cigarettes daily for the past year
expired-air carbon monoxide (CO) > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 months
Awards & highlights
Study Summary
This trial will test if a targeted intervention can help people stop smoking better than a standard intervention, using cigarettes with very low nicotine content.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Study 1 - Rate of Participant Completion of Pilot
Study 2 - Participant Abstinence Success at 2 Months
Study 2 - Participant Abstinence Success at 6 Months
Side effects data
From 2021 Phase 2 trial • 163 Patients • NCT0279639125%
Diarrhea
13%
Cough
13%
Irritability
13%
Dyspnea
13%
Nausea
13%
Stomach pain
13%
Vomiting
13%
Trigeminal nerve disorder
13%
Nasal congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study 1: Gradual Reduction
Study 2: Generic/Gradual Reduction
Study 2: Targeted/Gradual Reduction
Study 2: Generic/Immediate Reduction
Study 2: Targeted/Immediate Reduction
Study 1: Immediate Reduction
Trial Design
6Treatment groups
Experimental Treatment
Group I: Study 2: Targeted/Immediate ReductionExperimental Treatment2 Interventions
Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Group II: Study 2: Targeted/Gradual ReductionExperimental Treatment2 Interventions
Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive targeted materials (booklet series entitled ("Count down: Preparing to Quit Smoking with low-Nicotine Cigarettes") as well as one-on-one counseling.
Group III: Study 2: Generic/Immediate ReductionExperimental Treatment2 Interventions
Participants will receive VLNC (very low nicotine cigarettes) with the lowest nicotine dose (.03 mb nicotine yield). Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
Group IV: Study 2: Generic/Gradual ReductionExperimental Treatment2 Interventions
Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4. Participants will also receive the generic ("Clearing the Air") materials, as well as one-on-one counseling.
Group V: Study 1: Immediate ReductionExperimental Treatment2 Interventions
Participants will receive cigarettes with the lowest nicotine dose (.03 mb nicotine yield). They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Group VI: Study 1: Gradual ReductionExperimental Treatment2 Interventions
Participants will receive VLNC (very low nicotine cigarettes) containing nicotine yields of .7 mg for week 1, .26 mg for week 2, .12 for week 3, and .03 for week 4.They will receive a targeted intervention workbook ("Count down: Preparing to Quit Smoking with Low-Nicotine Cigarettes") and will be provided with one-on-one counseling.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Very Low Nicotine Content (VLNC) Cigarettes
2017
Completed Phase 2
~170
One on One Counseling
2017
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
538 Previous Clinical Trials
134,846 Total Patients Enrolled
James and Esther King Biomedical Research ProgramOTHER
13 Previous Clinical Trials
1,671 Total Patients Enrolled
Vani Simmons, Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
441 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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