Actívatexto for Smoking Cessation

Overseen By Francisco Cartujano, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Nicotine replacement

Disqualifiers: Pregnancy, Other tobacco use, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6 months

408 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial includes nicotine replacement therapies, it's best to discuss your current medications with the research team.

What data supports the effectiveness of the treatment Actívatexto for smoking cessation?

Research shows that combining behavioral therapy with drug treatments like nicotine patches or gum can help people quit smoking. These methods have been shown to double the chances of quitting compared to not using them. ^{1 2 3 4 5}

How is the Actívatexto treatment different from other smoking cessation treatments?

Actívatexto is unique because it likely incorporates a mobile-based intervention similar to Decídetexto, which uses a combination of personalized quit plans, text message counseling, and pharmacotherapy support, making it more interactive and personalized compared to traditional methods like nicotine patches or medications alone. ^{1 6 7 8 9}

What is the purpose of this trial?

The purpose of this randomized controlled trial is to assess the efficacy of Actívatexto (Aim 1) and the mediators of the presumed treatment effect (Aim 2) among Latino adults who smoke. Actívatexto is a mobile intervention that integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy \[i.e., nicotine replacement therapies (NRT)\], and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.

Eligibility Criteria

This trial is for Latino adults who smoke and are looking to quit, while also aiming to increase their physical activity. Participants should be comfortable using mobile interventions like text messaging programs and wearable devices.

Inclusion Criteria

Smoke cigarettes at least 3 days per week

I can read and speak English or Spanish.

I want to quit smoking within the next month.

Exclusion Criteria

Use of tobacco products other than cigarettes in the past 30 days (including e-cigarettes)

I cannot increase my physical activity or undergo a fitness evaluation.

Being pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment at enrollment

1 week

1 visit (in-person or virtual)

Treatment

Participants receive the Actívatexto or Decídetexto mobile intervention, nicotine replacement therapies, and a Fitbit Versa 4 device

6 months

Monthly virtual check-ins

Follow-up

Participants are monitored for smoking cessation and physical activity outcomes

6 months

Follow-up assessments at Months 3 and 6

Treatment Details

Interventions

• Actívatexto
• Decídetexto

Trial Overview The study tests Actívatexto, a program combining text messages promoting smoking cessation and exercise, with wearable tech for tracking activity, nicotine replacement therapies (NRT), and an online dashboard for data management by researchers.

Participant Groups

Group I: Actívatexto Experimental Treatment 1 Intervention

Actívatexto is a mobile intervention that promotes both smoking cessation and physical activity. Actívatexto integrates four components: 1) a text messaging program that promotes both smoking cessation and physical activity, 2) wearable devices to monitor physical activity, 3) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 4) an online dashboard where the research team manages participants' incoming and outgoing data from both the text messaging program and wearable devices.

Group II: Decídetexto Active Control 1 Intervention

Decídetexto is a mobile intervention that solely promotes smoking cessation. Decídetexto integrates three components: 1) a text messaging program that solely promotes smoking cessation, 2) smoking cessation pharmacotherapy (i.e., nicotine replacement therapies), and 3) an online dashboard where the research team manages participants' incoming and outgoing data from the text messaging program.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Hackensack Meridian Health

Collaborator

Trials

141

Recruited

42,900+

Findings from Research

Smoking is the leading cause of premature death in Western countries, highlighting the urgent need for effective cessation methods to help smokers quit early.

Current and emerging therapies, including novel medications and vaccines, show promise in improving the efficacy and safety of smoking cessation treatments, with many in advanced stages of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation: present status and future perspectives. Caponnetto, P., Russo, C., Polosa, R.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Photoelectric stimulation of defined ear points (Smokex-Pro method) as an aid for smoking cessation: a prospective observational 2-year study with 156 smokers in a primary care setting. [2011]

2. England pubmed.ncbi.nlm.nih.gov

Smoking cessation: present status and future perspectives. [2018]

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

Initiating Pharmacologic Treatment in Tobacco-Dependent Adults. [2023]

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

New developments in smoking cessation. [2019]

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

Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gum. [2021]

6. Spain pubmed.ncbi.nlm.nih.gov

Human pharmacological investigations of a transdermal nicotine system. [2015]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Decídetexto: Feasibility and Acceptability of a Mobile Smoking Cessation Intervention in Puerto Rico. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Exploring Users' Experiences With a Quick-Response Chatbot Within a Popular Smoking Cessation Smartphone App: Semistructured Interview Study. [2022]

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

Clinical strategies to enhance the efficacy of nicotine replacement therapy for smoking cessation: a review of the literature. [2021]