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

Trial Summary

What is the purpose of this trial?

Cigarette smoking is the leading cause of death and disability in the United States. People with psychiatric disorders consume almost half (44.3%) of all cigarettes smoked in the U.S. and have life spans more than 20 years shorter than the general population. Effective quit smoking treatments for people with psychiatric disorders are sorely needed. When patients are hospitalized for a psychiatric disorder, they are not allowed to smoke. This enforced period of no smoking creates what professionals call "a teachable moment". It provides an excellent opportunity to discuss the prospect of staying quit once the individual leaves the hospital. In ongoing research, the investigators have developed and tested a Sustained Care quit smoking intervention for smokers engaged in a psychiatric hospitalization. The intervention includes: 1) a professionally-led, motivational counseling session to encourage quitting smoking and increase awareness about available quit smoking resources, 2) a referral to the Texas Tobacco Quitline for phone-based, quit smoking counseling, and 3) an offer of 8 weeks of nicotine patches after leaving the hospital. Findings from a recently completed clinical trial provide strong support for this Sustained Care intervention. Aims in the current project are to develop and test a tablet computer-based, motivational counseling intervention that does not require a trained professional counselor. The goal is to conduct a clinical trial to demonstrate the effectiveness of this tablet-based, Sustained Care intervention for smokers engaged in psychiatric hospitalization. As before, the same quit smoking resources (Quitline and nicotine patches) will be provided upon hospital discharge. If successful, next steps will involve plans to implement this quit smoking intervention in psychiatric hospitals throughout Texas, in order to reduce the burden caused by tobacco-related cancers among the citizens of Texas.

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 data supports the effectiveness of the drug varenicline tartrate for smoking cessation?

Research shows that varenicline tartrate is effective for helping people quit smoking, with studies indicating it works better than other therapies over a long period. It helps reduce cravings and withdrawal symptoms, making it easier for people to stop smoking. ^{1 2 3 4 5}

Is the tablet-based sustained care treatment for smoking cessation safe for humans?

The treatment, known as varenicline (also called Chantix or Champix), has been generally safe in studies, but there are concerns about possible side effects like depression, suicidal thoughts, and changes in behavior. It's important to discuss these potential risks with a healthcare provider before starting the treatment. ^{1 5 6 7 8}

How is the drug varenicline tartrate unique for smoking cessation?

Varenicline tartrate is unique because it specifically targets the alpha4beta2 nicotinic receptors in the brain, reducing cravings and withdrawal symptoms while also blocking the pleasurable effects of nicotine, making it more effective than other smoking cessation therapies. ^{1 2 5 9 10}

Research Team

Richard Brown, Ph.D.

Principal Investigator

The University of Texas at Austin

Eligibility Criteria

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)

I am over 18 and can give my consent.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

References

1. New Zealand 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Two-year efficacy of varenicline tartrate and counselling for inpatient smoking cessation (STOP study): A randomized controlled clinical trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Characteristics and abstinence outcomes among tobacco quitline enrollees using varenicline or nicotine replacement therapy. [2015]

4. Belgium pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of varenicline as an aid to smoking cessation: results of an inter-European observational study. [2015]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. [2021]

7. England pubmed.ncbi.nlm.nih.gov

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

8. New Zealand pubmed.ncbi.nlm.nih.gov

Psychiatric adverse events in randomized, double-blind, placebo-controlled clinical trials of varenicline: a pooled analysis. [2022]

9. United States 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. [2022]

10. Australia pubmed.ncbi.nlm.nih.gov

Varenicline for smoking cessation: a placebo-controlled, randomized study. [2022]