Varenicline + Nicotine Lozenges for Smoking Cessation
(COMBOII Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks to find the best way to quit smoking by testing a combination of varenicline, a prescription drug that reduces cravings and withdrawal symptoms, and nicotine lozenges. It examines the effectiveness of these treatments when paired with smartphone apps that remind users to take their medication. The trial targets individuals who smoke at least five cigarettes a day and are ready to quit soon. It aims to determine if adding nicotine lozenges and smartphone reminders makes quitting easier and more successful. Participants will receive support calls and must commit to the program for about six months. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Do I have to stop taking my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. However, you must be willing to use varenicline and nicotine lozenges during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that varenicline is generally safe for most adults who want to quit smoking. In several studies, nausea was the most common side effect, affecting about 28% of people. Headaches were reported by around 15.5% of participants. Importantly, large studies found no increased risk of serious heart problems or death from using varenicline.
There is limited data on using varenicline with nicotine lozenges. However, varenicline is already approved for use on its own, suggesting its safety. The FDA even removed a previous warning about varenicline, indicating confidence in its safety.
Overall, while some people may experience side effects, the treatment is considered well-tolerated. Many find it helpful for quitting smoking, which can greatly improve health over time.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these smoking cessation treatments because they combine varenicline, a widely used smoking cessation aid, with nicotine lozenges and innovative smartphone interventions. Varenicline itself is known for reducing cravings and withdrawal symptoms, but these trial treatments take it a step further by incorporating a digital adherence component. Unlike traditional methods, which may rely solely on medication or counseling, these treatments use smartphone technology to enhance adherence and provide personalized support. This approach could potentially increase the success rates of quitting smoking by making it easier for participants to stick to their treatment plan and access support whenever they need it.
What evidence suggests that this trial's treatments could be effective for smoking cessation?
Research has shown that varenicline effectively helps people stop smoking. Studies indicate it significantly increases the chances of quitting compared to no treatment. In this trial, some participants will receive varenicline along with nicotine replacement products, such as lozenges, which might further enhance long-term success. A review of several studies found that combining treatments works better than using just one. Additionally, some participants will receive a smartphone-based intervention. Early results suggest that smartphone reminders could help people remember to take their medication, potentially improving quit rates.678910
Who Is on the Research Team?
Darla E. Kendzor, Ph.D.
Principal Investigator
The University of Oklahoma Health Sciences
Jasjit S. Ahluwalia, MD
Principal Investigator
Brown University
Are You a Good Fit for This Trial?
This trial is for adults who smoke cigarettes daily and are interested in quitting. Participants must be willing to use a smartphone app to help with medication adherence and can't already be using cessation pharmacotherapy or behavioral treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 13 weeks of varenicline and 12 weeks of nicotine lozenges, with a smartphone-based intervention and up to 6 telephone counseling sessions.
Follow-up
Participants are monitored for smoking abstinence and medication adherence, with assessments at 26 weeks post-quit date.
Long-term Follow-up
Participants' smoking abstinence is biochemically verified at 26 weeks post-quit date.
What Are the Treatments Tested in This Trial?
Interventions
- Nicotine lozenge
- Varenicline
Trial Overview
The study tests if combining Varenicline (a smoking cessation drug) with nicotine lozenges and a smartphone adherence intervention helps people quit smoking better than just Varenicline alone. It's a randomized trial where participants also get either an app that tracks medication taking or one without these features.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants will receive 13 weeks of varenicline (1 titration week + 12 weeks at full twice daily 1 mg dosing) and a smartphone-based smoking cessation intervention without medication adherence components. All participants will receive up to 6 telephone counseling calls.
Participants will receive 13 weeks of varenicline (1 titration week + 12 weeks at full twice daily 1 mg dosing) and a smartphone-based smoking cessation intervention with medication adherence components. All participants will receive up to 6 telephone counseling calls.
Participants will receive 13 weeks of varenicline (1 titration week + 12 weeks at full twice daily 1 mg dosing), 12 weeks of nicotine lozenges (2 mg or 4 mg), and a smartphone-based smoking cessation intervention without medication adherence components. All participants will receive up to 6 telephone counseling calls.
Participants will receive 13 weeks of varenicline (1 titration week + 12 weeks at full twice daily 1 mg dosing), 12 weeks of nicotine lozenges (2 mg or 4 mg), and a smartphone-based smoking cessation intervention with medication adherence components. All participants will receive up to 6 telephone counseling calls.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Oklahoma
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Brown University
Collaborator
Thomas Jefferson University
Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborator
OU Health Stephenson Cancer Center
Collaborator
Citations
Effect of Varenicline on Smoking Cessation Through ...
Varenicline significantly increases smoking abstinence rates among smokers seeking treatment and quitting abruptly., Among smokers not trying to stop, ...
Enhanced vs Standard Varenicline Treatment for Tobacco ...
Tobacco cessation at 52 weeks was 25.1% (79 of 315) for 12-week monotherapy, 24.4% (76 of 311) for 24-week monotherapy, 23.6% (74 of 314) for 12 ...
3.
tobaccopreventioncessation.com
tobaccopreventioncessation.com/Cue-restricted-smoking-increases-quit-rates-with-varenicline,133570,0,2.htmlCue restricted smoking increases quit rates with varenicline
However, the best cessation results achieved with varenicline plus behavioral counseling are less than 45% during the period of varenicline use ...
4.
tobaccoinduceddiseases.org
tobaccoinduceddiseases.org/Determinants-of-successful-smoking-cessation-in-outpatient-settings-A-comparative,208449,0,2.htmlDeterminants of successful smoking cessation in outpatient ...
Varenicline users showed a significantly higher quitting success ... Effect of varenicline on smoking cessation through smoking reduction ...
Varenicline for smoking cessation: a narrative review of ...
Extending the use of varenicline from 12 to 24 weeks reduces relapse and improves smoking cessation outcomes.
Safety review update of Chantix (varenicline) and risk ...
The meta-analysis showed that exposure to Chantix resulted in an adjusted hazard ratio of MACE of 1.95 (95% confidence interval: 0.79, 4.82).
Varenicline for smoking cessation: efficacy, safety, and ...
The most commonly reported adverse events experienced by subjects on varenicline in clinical trials were nausea (28.1% versus 8.4% placebo), headache (15.5% ...
Efficacy and Safety of Varenicline for Smoking Cessation in ...
Throughout the trial, patients in the varenicline group were at least 3 times more likely to quit smoking compared with patients in the placebo ...
Varenicline and Adverse Cardiovascular Events
When pooling data from 38 RCTs, we found no evidence of an increased risk of cardiovascular SAEs or all‐cause mortality with varenicline.
Varenicline for smoking cessation in individuals who ...
Safety reporting. Safety data were summarised for both treatment groups and summary statistics reported. Any events documented in the period ...
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