Adaptive Treatment for Smoking Relapse
(ADAPT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Disqualifiers: Non-smokers
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each.
All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Chantix for smoking cessation?
Research shows that Chantix (varenicline) helps people quit smoking by reducing the chance of relapse after a slip during a quit attempt. In one study, switching to Chantix after initial treatment with a nicotine patch increased the likelihood of staying smoke-free at six months.
12345Is the treatment for smoking relapse, known as Chantix or varenicline, safe for humans?
Varenicline (Chantix) is generally used for smoking cessation, but there are safety concerns. It may cause neuropsychiatric side effects (mental health-related issues), seizures, and interactions with alcohol. Some people have also reported abnormal sleep-related events.
46789How is the drug Chantix (varenicline) unique for treating smoking relapse?
Chantix (varenicline) is unique because it not only helps people quit smoking by reducing withdrawal symptoms and cravings, but it also lowers the chance of a full relapse if someone slips and smokes a cigarette during their quit attempt. This makes it different from other treatments that may not address the risk of relapse as effectively.
47101112Eligibility Criteria
This trial is for smokers who are eager to quit. It's not suitable for non-smokers or those who aren't looking to stop smoking.Inclusion Criteria
I am a smoker and want to quit.
Exclusion Criteria
Non-smokers
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a 12-week course of smoking cessation treatment, including nicotine replacement therapies, varenicline, or e-cigarettes, with adaptive adjustments based on response.
12 weeks
All visits and assessments are remote
Follow-up
Participants are monitored for smoking cessation outcomes and other measures at 6 months after the start of the study.
12 weeks
Final follow-up survey at 6 months
Participant Groups
The study tests if changing treatments helps people struggling to quit smoking. Participants will use nicotine replacement, varenicline, or e-cigarettes and may switch between them based on their quitting progress.
4Treatment groups
Experimental Treatment
Group I: Non-Adaptive Randomization 2Experimental Treatment1 Intervention
This arm includes people who did not respond to two 4-week courses of pharmacotherapy (either varenicline or combination NRT or both sequentially). After two four-week courses of pharmacotherapy, participants that are not responding to the medication will receive four additional weeks of the same medication with instructions to try to quit again.
Group II: Non-Adaptive Randomization 1Experimental Treatment1 Intervention
This arm includes people who did not respond to 4 weeks of pharmacotherapy (either varenicline or combination NRT). After a 4-week course of pharmacotherapy, participants that are not responding to the medication will receive four additional weeks of the same medication with instructions to try to quit again
Group III: Harm Reduction Randomization 2Experimental Treatment1 Intervention
This arm includes people who did not respond to two 4-week courses of pharmacotherapy (either varenicline or combination NRT or both). After two 4-week courses of pharmacotherapy, participants who are not responding to medication will be randomly assigned to a harm reduction group (e-cigarettes). Participants assigned to the harm reduction group will receive four weeks of e-cigarette product with instructions to switch completely
Group IV: Adaptive Randomization 1Experimental Treatment1 Intervention
This arm includes people who did not respond to 4 weeks of pharmacotherapy (either varenicline or combination NRT). After a 4-week course of pharmacotherapy, participants that are not responding to medication will receive four weeks of the other FDA approved option, either varenicline or combination NRT, with instructions to try to quit again
Adaptive Treatment for Early Smoking Cessation Relapse is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Chantix for:
- Smoking cessation
🇪🇺 Approved in European Union as Champix for:
- Smoking cessation
🇨🇦 Approved in Canada as Champix for:
- Smoking cessation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Adapting smoking cessation treatment according to initial response to precessation nicotine patch. [2022]OBJECTIVE The authors evaluated an adaptive smoking cessation treatment strategy in which nicotine patch treatment was initiated before a quit date, and then, depending on initial therapeutic response, either the nicotine patch was continued or alternative pharmacotherapies were provided. METHOD The study was a double-blind, parallel-arm adaptive treatment trial. A total of 606 cigarette smokers started open-label nicotine patch treatment 2 weeks before the quit date. Those whose ad lib smoking did not decrease by >50% after 1 week were randomly assigned to one of three double-blind treatments: nicotine patch alone (control condition); "rescue" treatment with bupropion augmentation of the patch; or rescue treatment with varenicline alone. Participants whose precessation smoking decreased >50% but who lapsed after the quit date were also randomly assigned to the two rescue treatments or to nicotine patch alone. Logistic regression analyses compared each rescue treatment against the control condition in terms of abstinence at the end of treatment (weeks 8-11) and at 6 months. RESULTS Smokers who did not respond adequately to precessation nicotine patch benefited from bupropion augmentation; abstinence rates at end of treatment were 16% with nicotine patch alone and 28% with bupropion augmentation (odds ratio=2.04, 95% CI=1.03-4.01). Switching to varenicline produced less robust effects, but point abstinence at 6 months was 6.6% with the patch alone and 16.5% with a switch to varenicline (odds ratio=2.80, 95% CI=1.11-7.06). Postquit adaptive changes in treatment had no significant effects on any abstinence outcome. CONCLUSIONS It is possible to rescue a significant portion of smokers who would have failed to achieve abstinence if left on nicotine patch alone by identifying these smokers before their quit date and implementing adaptive changes in treatment.
Varenicline in prevention of relapse to smoking: effect of quit pattern on response to extended treatment. [2017]While older behavioural and pharmacological approaches to preventing relapse to smoking show little efficacy, a recent randomized trial of an extended course of varenicline reported positive results. In this secondary analysis, trial data were examined to see whether smokers who manage to achieve abstinence only later in the original course of treatment are more likely to benefit from having the course extended.
The use of biomarkers to guide precision treatment for tobacco use. [2023]This review summarizes the evidence to date on the development of biomarkers for personalizing the pharmacological treatment of combustible tobacco use. First, the latest evidence on FDA-approved medications is considered, demonstrating that, while these medications offer real benefits, they do not contribute to smoking cessation in approximately two-thirds of cases. Second, the case for using biomarkers to guide tobacco treatment is made based on the potential to increase medication effectiveness and uptake and reduce side effects. Next, the FDA framework of biomarker development is presented along with the state of science on biomarkers for tobacco treatment, including a review of the nicotine metabolite ratio, electroencephalographic event-related potentials, and other biomarkers utilized for risk feedback. We conclude with a discussion of the challenges and opportunities for the translation of biomarkers to guide tobacco treatment and propose priorities for future research.
Effects of varenicline on abstinence and smoking reward following a programmed lapse. [2021]Varenicline (Chantix®) is an efficacious first-line medication for smoking cessation. Studies suggest that one mechanism by which varenicline facilitates sustained smoking abstinence is by reducing the likelihood of relapse to smoking when a lapse, or slip, occurs during a quit attempt. The present study extends this line of research by conducting a prospective laboratory study to examine the relapse prevention effects of varenicline following a programmed lapse.
Adaptive Smoking Cessation Using Precessation Varenicline or Nicotine Patch: A Randomized Clinical Trial. [2023]Adaptive pharmacotherapy, ie, starting a medication regimen and then modifying that regimen based on patient response, is common in many medical domains but is not common in smoking cessation. Recently, studies have found that adaptive treatment using precessation nicotine patches is efficacious for smoking cessation; however, adaptive treatment using precessation varenicline and adaptive treatment in clinical practice settings have not been fully assessed.
Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation. [2022]The selective nicotinic acetylcholine receptor partial agonist, varenicline tartrate, represents a novel type of therapy for smoking cessation. This study evaluated the efficacy, safety, and tolerability of 4 varenicline dose regimens, 2 with progressive dosing over the first week (eg, titrated) and 2 with a fixed dosing schedule (eg, non-titrated), for promoting smoking cessation.
A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence. [2020]Continuing to smoke after a cancer diagnosis undermines prognosis. Yet few trials have tested Food and Drug Administration (FDA)-approved tobacco use medications in this population. Extended use varenicline may represent an effective treatment for cancer patients who smoke given barriers to cessation including a prolonged time line for relapse.
Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. [2018]Smoking cessation remains a positive therapeutic goal and should be encouraged for the millions of individuals who continue to smoke and struggle to quit. While psychiatric nurses should encourage patients to start or continue smoking cessation therapies, they must be aware of the additional safety concerns relating to the use of varenicline (Chantix). Research published subsequent to the last clinical update in this journal (Tobin, 2007 ) has prompted additional warnings from the Food and Drug Administration concerning varenicline for smoking cessation therapy. In particular, clinicians need to be aware of increased concerns about varenicline's association with neuropsychiatric side effects, seizures, and alcohol interactions.
Varenicline and abnormal sleep related events. [2018]To assess adverse drug reaction reports of "abnormal sleep related events" associated with varenicline, a partial agonist to the α4β2 subtype of nicotinic acetylcholine receptors on neurones, indicated for smoking cessation.
Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. [2015]Telephone counseling through quitlines combined with cessation medication is an effective strategy to support tobacco cessation. This study assessed the characteristics of quitline enrollees selecting varenicline (Chantix) compared with nicotine replacement therapy (NRT) medication and evaluated the cessation outcomes (7-day point prevalence) among these enrollees at 3 and 6 months after program completion.
Treatment of nicotine dependence with Chantix (varenicline). [2015]Varenicline is the generic name for Chantix, the newest drug available for the treatment of tobacco dependence. In a randomized controlled clinical trial, the abstinence rate at 1 year for patients using varencline was superior to that of patients in the group using bupropion SR (Zyban) and in the placebo group (11). Varenicline reduces nicotine withdrawal symptoms, cigarette craving and nicotine satisfaction. Post-market reports prompted a warning of serious adverse neuropsychiatric events in patients taking varenicline. As is the case with any surgical procedure and/or prescription medication, full disclosure of the risks and benefits should be discussed with the patient. The significant health benefits of quitting smoking should be weighed against the individual's risk of adverse events associated with the use of varenicline for smoking cessation.
Extended interactive voice response telephony (IVR) for relapse prevention after smoking cessation using varenicline and IVR: a pilot study. [2021]There is a significant resumption of smoking following smoking cessation using varenicline. Both smoking cessation medications and counseling have been shown to increase smoking quit rates at one year. Thus, the combination of varenicline and interactive voice response (IVR) telephony followed by extended IVR may further improve smoking cessation rates at one and two years.