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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-target quit day (tqd)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-target quit day (tqd)
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: 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 II: 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 III: 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 IV: 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 V: 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 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 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 VIII: 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 IX: 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 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.
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,184 Previous Clinical Trials
3,168,963 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,465 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using birth control as a woman who can still have children.You have had thoughts of harming yourself or attempted to harm yourself in the past.I am currently taking bupropion or varenicline.You have been smoking at least 4 cigarettes every day for the past 6 months.I am cleared to take the medications used in this study.
Research Study Groups:
This trial has the following groups:- Group 1: 12-week Varenicline with Intensive Counseling
- Group 2: 24-week Varenicline with 4-Week Preparation Varenicline and Intensive Counseling
- Group 3: 24-week Varenicline with 4-Week Preparation Varenicline and Minimal Counseling
- Group 4: 12-week Varenicline with 4-Week Preparation Varenicline and Intensive Counseling
- Group 5: 12-week C-NRT with Minimal Counseling
- Group 6: 12-week C-NRT with 4-Week Preparation C-NRT and Intensive Counseling
- Group 7: 24-week C-NRT with 4-Week Preparation C-NRT and Intensive Counseling
- Group 8: 12-week C-NRT with 4-Week Preparation C-NRT and Minimal Counseling
- Group 9: 24-week C-NRT with Intensive Counseling
- Group 10: 12-week C-NRT with Intensive Counseling
- Group 11: 24-week Varenicline with Minimal Counseling
- Group 12: 24-week C-NRT with 4-Week Preparation C-NRT and Minimal Counseling
- Group 13: 24-week C-NRT with Minimal Counseling
- Group 14: 12-week Varenicline with Minimal Counseling
- Group 15: 12-week Varenicline with 4-Week Preparation Varenicline and Minimal Counseling
- Group 16: 24-week Varenicline with Intensive Counseling
Awards:
This trial has 3 awards, including:- 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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other studies have been done on Varenicline over a 24-week period, with 4 weeks of preparation and minimal counseling?
"There are 28 clinical trials currently underway researching the effects of 24-week Varenicline with 4-Week Preparation Varenicline and Minimal Counseling. Of these, 4 are in Phase 3. While Charleston, South carolina has a high concentration of these studies, there are 71 total locations for these trials across the world."
Answered by AI
Are there any patients who could still join this research project?
"Indeed, the information available on clinicaltrials.gov verifies that this study is still looking for volunteers. This trial was first posted on December 10th 2020 and was last updated on October 4th 2022. They are hoping to find 608 individuals total from 2 locations."
Answered by AI
What is the upper limit for volunteers in this clinical trial?
"Yes, that is correct. The information available on clinicaltrials.gov states that the trial is looking for 608 patients at 2 sites. The study was first posted on December 10th, 2020 and was last updated on October 4th, 2022."
Answered by AI
Is Varenicline a safe drug to take for extended periods of time?
"Since this is a Phase 4 clinical trial, the safety of 24-week Varenicline with 4-Week Preparation Varenicline and Minimal Counseling has been well established and received a score of 3."
Answered by AI
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