Tablet-Based Sustained Care for Smoking Cessation

Overseen By Richard Brown, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Dementia, Cognitive impairment, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with psychiatric disorders quit smoking using a tablet-based program. The program includes motivational counseling on a tablet, a referral to a quitline for phone support, and nicotine patches after hospital discharge. The trial will compare this new method to standard hospital care, which involves a brief education session with a nurse. Individuals who smoke at least five cigarettes a day and are hospitalized for a psychiatric disorder might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative methods for quitting smoking.

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 focuses on smoking cessation and does not mention changes to other medications.

What prior data suggests that this tablet-based intervention is safe for smoking cessation?

Research shows that the treatment under study, called tablet-based sustained care, helps people quit smoking. This digital method encourages smokers to quit, particularly those hospitalized for mental health issues.

Previous studies have found that sustained care methods, including motivational counseling and support like nicotine patches, effectively help people stop smoking. These methods are generally safe and well-tolerated. The treatment aims to reduce the need for a professional counselor by using a tablet-based program.

While specific safety data for this exact tablet-based program is not available, its components, such as motivational counseling and nicotine patches, are commonly used in smoking cessation programs. These components have been shown to be safe for most people.

Participants in this trial will use a tablet for counseling and may receive follow-up support, such as the Texas Tobacco Quitline and nicotine patches. These are standard tools in smoking cessation efforts and are usually safe, though individual reactions may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the tablet-based sustained care for smoking cessation because it offers a novel way to maintain support after initial quit attempts. Unlike traditional methods that often rely on brief counseling sessions or nicotine replacement therapies, this approach uses a digital platform to provide continuous encouragement and resources. This method could make quitting smoking more accessible and adaptable to individual needs, potentially increasing long-term success rates for those trying to quit.

What evidence suggests that this tablet-based sustained care is effective for smoking cessation?

This trial will compare a Tablet-Based Sustained Care program with Usual Care for smoking cessation. Research has shown that the Sustained Care program aids smokers with mental health issues in quitting. A recent study supported this approach, which includes counseling, a quitline, and nicotine patches. The tablet version provides the same assistance without a counselor. This method leverages a "teachable moment" during psychiatric hospital stays when patients cannot smoke, making quitting easier. The goal is to help these smokers quit permanently and reduce smoking-related health problems. ^{4 6 7 8 9}

Who Is on the Research Team?

Richard Brown, Ph.D.

Principal Investigator

The University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for adults over 18 who smoke at least 5 cigarettes a day when not hospitalized, can give informed consent, and are able to attend all study visits. It's not for those with dementia or severe cognitive issues, substance detox needs, no phone access or stable address, institutional discharge plans post-hospitalization, pregnancy/breastfeeding women, or those with health risks from nicotine patches.

Inclusion Criteria

Willing and able to provide informed consent, attend all study visits, and comply with the protocol

Current smoker (at least 5 cigarettes/day when not hospitalized)

Exclusion Criteria

Currently pregnant or breastfeeding

My MMSE score is below 24, indicating cognitive concerns.

Current diagnosis of a (non-nicotine) substance use disorder requiring detoxification

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a tablet-based motivational counseling intervention and are provided with quit smoking resources upon hospital discharge

8 weeks

1 visit (in-person) during hospitalization

Follow-up

Participants are monitored for smoking cessation and psychiatric symptoms at 1, 3, and 6 months post-hospital discharge

6 months

3 follow-up assessments (virtual or phone)

Extension

Potential long-term follow-up to assess sustained smoking cessation and psychiatric health

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Tablet-based sustained care

Trial Overview The trial tests a tablet-based program designed to help people quit smoking after psychiatric hospitalization. It includes motivational counseling without the need for professional counselors and provides resources like quitline referrals and nicotine patches upon leaving the hospital.

How Is the Trial Designed?

Group I: Tablet-based Sustained Care Experimental Treatment 1 Intervention

Intervention to support sustained smoking cessation.

Group II: Usual Care Active Control 1 Intervention

Standard hospital care: : A brief (5-10 min.) tobacco education session from a hospital nurse, along with educational materials about quitting and a quitline brochure.

Tablet-based sustained care is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Chantix for:

• Smoking cessation
• Dry eye disease

Approved in European Union as Champix for:

• Smoking cessation

Approved in Canada as Champix for:

• Smoking cessation

Approved in United States as Tyrvaya for:

• Dry eye disease

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Ascension Seton Shoal Creek

Collaborator

Trials

1

Recruited

250+

Cancer Prevention Research Institute of Texas

Collaborator

Trials

55

Recruited

98,900+

Published Research Related to This Trial

Participants who chose varenicline (3,116 individuals) for tobacco cessation had higher abstinence rates at both 3 months (22%) and 6 months (17%) compared to those using nicotine replacement therapy (NRT) (13% at 3 months and 11% at 6 months), indicating that varenicline may be more effective in supporting quitting.

The study found that factors such as increasing age, having health insurance, and the number of counseling sessions were associated with higher rates of abstinence, particularly at 3 months, suggesting that these factors could enhance the effectiveness of quitline services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. Biazzo, LL., Froshaug, DB., Harwell, TS., et al.[2015]

Smoking cessation is crucial for health, and psychiatric nurses should actively support patients in using therapies like varenicline (Chantix) to quit smoking.

Recent research has raised safety concerns about varenicline, including its potential links to neuropsychiatric side effects, seizures, and interactions with alcohol, which clinicians need to consider when recommending this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Psychopharmacology Update: Additional Safety Concerns for Using Varenicline (Chantix) for Smoking Cessation Treatment. Tobin, TJ., Tobin, ML.[2018]

In a study of 12,159 patients, varenicline was associated with reported neuropsychiatric events, particularly anxiety, but no significant increase in these events was found over time, suggesting that the drug's safety profile remains largely stable.

While 7-17% of neuropsychiatric events were attributed to varenicline by general practitioners, the analysis did not raise significant safety concerns, indicating that further investigation is needed to clarify the relationship between varenicline and anxiety symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Buggy, Y., Cornelius, V., Fogg, C., et al.[2021]

In a 24-week study involving 333 participants from China, Singapore, and Thailand, varenicline was found to be significantly more effective than placebo for smoking cessation, with 50.3% of participants achieving 4-week continuous abstinence compared to 31.6% in the placebo group.

Varenicline was safe and well tolerated, showing no significant side effects, which supports its use as a viable option for helping smokers quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Varenicline for smoking cessation: a placebo-controlled, randomized study. Wang, C., Xiao, D., Chan, KP., et al.[2022]

In a study of 2,682 patients using varenicline for smoking cessation, nausea and vomiting were the most common reasons for discontinuation and the most frequently reported adverse drug reactions, highlighting the need for patient monitoring regarding gastrointestinal side effects.

While some psychiatric events were reported, including anxiety and depression, all cases of suicidal behavior involved patients with prior psychiatric conditions, suggesting that clinicians should closely monitor individuals with such histories when prescribing varenicline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. Kasliwal, R., Wilton, LV., Shakir, SA.[2021]

Varenicline (Champix) is a newly approved medication for smoking cessation that acts as a partial agonist of nicotinic receptors, offering a different mechanism of action compared to traditional therapies like nicotine replacement and bupropion.

Recent studies indicate that varenicline is effective in helping individuals quit smoking and may have advantages over existing treatments, although potential side effects are also discussed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug of the month. Varenicline (Champix)]. Vandemergel, X.[2015]

In a real-world study involving 566 participants across four European countries, varenicline was found to be an effective smoking cessation aid, with a 64.6% quit rate by the end of the 12-week treatment period.

The safety profile of varenicline was acceptable, with the most common side effects being mild to moderate nausea (8.9%) and insomnia (2.9%), and only 3.4% of participants discontinued due to treatment-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. Boudrez, H., Gratziou, C., Messig, M., et al.[2015]

In a study of 392 adult patients with smoking-related illnesses, those who received varenicline tartrate plus Quitline-counselling had a significantly higher continuous smoking abstinence rate at 104 weeks (29.2%) compared to those who only received counselling (18.8%).

This research is the first to evaluate the long-term efficacy and safety of varenicline tartrate in an inpatient setting, demonstrating its effectiveness as a treatment for smokers admitted with tobacco-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year efficacy of varenicline tartrate and counselling for inpatient smoking cessation (STOP study): A randomized controlled clinical trial. Carson-Chahhoud, KV., Smith, BJ., Peters, MJ., et al.[2023]

In a review of ten randomized controlled trials involving 3091 participants, varenicline did not show a significant increase in overall psychiatric disorders compared to placebo, with an incidence of 10.7% in the varenicline group versus 9.7% in the placebo group.

While varenicline was associated with a higher incidence of sleep disorders, there were no reported cases of suicidal ideation or behavior in the analyzed studies, suggesting that varenicline is generally safe for smokers without current psychiatric conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. Tonstad, S., Davies, S., Flammer, M., et al.[2022]

In a phase 2 study involving 411 healthy smokers, varenicline tartrate at doses of 1.0 mg once and twice daily significantly increased quit rates compared to placebo, with 48.0% and 37.3% quitting respectively, versus only 17.1% for placebo.

Varenicline was well tolerated, with discontinuation rates due to adverse events similar to placebo, indicating it is a safe and effective option for smoking cessation, especially at the 1.0 mg twice daily dose for long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation with varenicline, a selective alpha4beta2 nicotinic receptor partial agonist: results from a 7-week, randomized, placebo- and bupropion-controlled trial with 1-year follow-up. Nides, M., Oncken, C., Gonzales, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8897753/

Effect of Combination Treatment With Varenicline and ... This study found that combined treatment with varenicline and nicotine patch improved smoking cessation outcomes among smokers who drink heavily.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871622004094

Varenicline and related interventions on smoking cessation (2006 ) pooled four trials and found that varenicline was superior to placebo treatment even one year later, and they also showed that ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2629973/

Smoking cessation therapy with varenicline - PubMed Central This study concluded that varenicline was significantly more efficacious than placebo for smoking cessation at all time points and significantly more ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0231095

Two-year efficacy of varenicline tartrate and counselling for ... Varenicline tartrate is superior for smoking cessation to other tobacco cessation therapies by 52 weeks, in the outpatient setting. We aimed to ...

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2016/021928s040lbl.pdf

CHANTIX (varenicline) tablets, for oral use - accessdata.fda.gov The patient should set a date to stop smoking. Begin CHANTIX dosing one week before this date. Alternatively, the patient can begin CHANTIX dosing and then quit.

6. fda.gov fda.gov/media/181796/download

Chantix Pediatric Postmarketing Safety Review This review focuses on. United States (U.S.) serious unlabeled adverse events associated with varenicline tartrate in pediatric patients.

7. withpower.com withpower.com/trial/phase-smoking-cessation-2-2023-c566f

Tablet-Based Sustained Care for Smoking Cessation The treatment, known as varenicline (also called Chantix or Champix), has been generally safe in studies, but there are concerns about possible side effects ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3242617/

Safety and Tolerability of Varenicline Tartrate (Champix®/ ... In summary, varenicline was as safe in HIV-infected smokers as in HIV-negative smokers, although AEs were common and occasionally resulted in drug cessation.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820435

Varenicline and Nicotine Replacement Therapy for ... Varenicline is the most effective sole pharmacotherapy for smoking cessation and is as effective as combination nicotine replacement therapy ( ...