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Nicotine Replacement Therapy

Smoking Cessation Medications for Smoking Addiction

Phase 4
Waitlist Available
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 12 months post-target quit day (tqd)
Awards & highlights

Study Summary

This trial will compare different combinations of two smoking cessation medications (varenicline and C-NRT) to see which is most effective in helping people quit smoking.

Who is the study for?
This trial is for daily smokers who've been smoking more than 4 cigarettes a day for the past 6 months, can use study medications safely, and if female and able to have children, must be using birth control. Smokers already on bupropion or varenicline or with recent suicidal thoughts or attempts cannot join.Check my eligibility
What is being tested?
The study tests different strategies to quit smoking using two main treatments: Combination Nicotine Replacement (C-NRT) and varenicline. It looks at medication type, preparation time before quitting, treatment duration, and counseling intensity in various combinations over a year.See study design
What are the potential side effects?
Possible side effects include nausea, sleep problems (insomnia), skin reactions at the site of NRT patch application, headache, difficulty concentrating, gas or heartburn from nicotine gum or lozenges.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-target quit day (tqd)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-target quit day (tqd) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intent-to-treat biochemically verified 7-day point prevalence abstinence
Secondary outcome measures
Cost-effectiveness

Trial Design

16Treatment groups
Active Control
Group I: 24-week Varenicline with 4-Week Preparation Varenicline and Minimal CounselingActive Control2 Interventions
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Group II: 12-week Varenicline with 4-Week Preparation Varenicline and Intensive CounselingActive Control2 Interventions
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Group III: 24-week Varenicline with 4-Week Preparation Varenicline and Intensive CounselingActive Control2 Interventions
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 weeks prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 24 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Group IV: 12-week C-NRT with Minimal CounselingActive Control2 Interventions
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Group V: 12-week C-NRT with 4-Week Preparation C-NRT and Minimal CounselingActive Control2 Interventions
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke >10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief 15-30 minute phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Group VI: 12-week C-NRT with 4-Week Preparation C-NRT and Intensive CounselingActive Control2 Interventions
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 12 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke >10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Group VII: 24-week C-NRT with Intensive CounselingActive Control2 Interventions
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Group VIII: 24-week C-NRT with 4-Week Preparation C-NRT and Intensive CounselingActive Control2 Interventions
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke >10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Group IX: 12-week Varenicline with Intensive CounselingActive Control2 Interventions
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Group X: 12-week C-NRT with Intensive CounselingActive Control2 Interventions
Participants randomized to this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges to use starting on their quit day. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.
Group XI: 24-week Varenicline with Minimal CounselingActive Control2 Interventions
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Group XII: 24-week C-NRT with 4-Week Preparation C-NRT and Minimal CounselingActive Control2 Interventions
Participants randomized to this intervention will receive 14 mg patches starting 4 weeks prior to the target quit day (TQD). Then, starting on the TQD, participants will receive 24 weeks of nicotine patches and nicotine mini-lozenges. Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Group XIII: 24-week C-NRT with Minimal CounselingActive Control2 Interventions
Participants randomized to this intervention will receive 24 weeks of nicotine patches and nicotine mini-lozenges, starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 20 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 22 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Group XIV: 12-week Varenicline with Minimal CounselingActive Control2 Interventions
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Group XV: 12-week Varenicline with 4-Week Preparation Varenicline and Minimal CounselingActive Control2 Interventions
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 4 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily for the next 3 weeks pre-TQD and until 12 weeks post-TQD. Participants randomized to this intervention will receive a brief (15-30 minute) phone or video counseling session 1 week prior to the TQD to promote engagement with free mobile health resources and then a brief (10-20 minute) follow-up phone or video session during the first week post-TQD to mimic a nurse or clinician follow-up after a quit attempt.
Group XVI: 24-week Varenicline with Intensive CounselingActive Control2 Interventions
Participants randomized to this intervention will receive one 0.5 mg pill for the first 3 days, starting 1 week prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 23 weeks post-TQD. Participants randomized to this intervention will receive four 15-20 minute phone or video counseling sessions (1 prior to the TQD, 1 during the first week post-TQD and during Weeks 2 and 4 post-TQD). The counseling is designed to produce intra-treatment support and skill training, consistent with the Public Health Service (PHS) Clinical Practice Guideline.

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,193 Previous Clinical Trials
3,161,261 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,952,756 Total Patients Enrolled
1 Trials studying Nicotine Addiction
20 Patients Enrolled for Nicotine Addiction
Megan E Piper, PhDStudy DirectorUniversity of Wisconsin Center for Tobacco Research and Intervention
3 Previous Clinical Trials
862 Total Patients Enrolled

Media Library

Combination Nicotine Replacement Therapy (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04188873 — Phase 4
Nicotine Addiction Research Study Groups: 24-week Varenicline with 4-Week Preparation Varenicline and Minimal Counseling, 12-week Varenicline with 4-Week Preparation Varenicline and Intensive Counseling, 24-week Varenicline with 4-Week Preparation Varenicline and Intensive Counseling, 12-week C-NRT with Minimal Counseling, 12-week C-NRT with 4-Week Preparation C-NRT and Minimal Counseling, 12-week C-NRT with 4-Week Preparation C-NRT and Intensive Counseling, 24-week C-NRT with Intensive Counseling, 24-week C-NRT with 4-Week Preparation C-NRT and Intensive Counseling, 12-week Varenicline with Intensive Counseling, 12-week C-NRT with Intensive Counseling, 24-week Varenicline with Minimal Counseling, 24-week C-NRT with 4-Week Preparation C-NRT and Minimal Counseling, 24-week C-NRT with Minimal Counseling, 12-week Varenicline with Minimal Counseling, 12-week Varenicline with 4-Week Preparation Varenicline and Minimal Counseling, 24-week Varenicline with Intensive Counseling
Nicotine Addiction Clinical Trial 2023: Combination Nicotine Replacement Therapy Highlights & Side Effects. Trial Name: NCT04188873 — Phase 4
Combination Nicotine Replacement Therapy (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04188873 — Phase 4
~28 spots leftby Aug 2024
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