Automated Smoking Cessation for People Living With HIV

Overseen By Sarah R Jones

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Smoking cessation

Disqualifiers: Pregnant, Breastfeeding, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help people living with HIV quit smoking. One group will use an Automated Treatment featuring a smartphone app with videos and text support. The other group will follow the Standard Treatment, receiving guidance from their state's quitline, which includes options like nicotine lozenges and patches. Eligibility requires having smoked over 100 cigarettes in a lifetime, currently smoking more than 5 cigarettes a day, being HIV positive, and owning a smartphone. As an unphased trial, this study provides a unique opportunity to explore innovative methods for quitting smoking and improving health.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be using smoking cessation medications to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both nicotine lozenges and nicotine patches are generally safe and effective for helping people quit smoking. In one study, participants used nicotine lozenges for up to a year and found them easy to use. However, nicotine remains highly addictive.

Studies have also confirmed the safety of nicotine patches, which help ease withdrawal symptoms when quitting smoking. Although the patch can increase nicotine levels in the blood, it is considered safe for most people.

For the smartphone-delivered treatment, research indicates that digital tools like text messages and videos are safe and helpful. These tools have been used successfully to help people with HIV adhere to their medication schedules, suggesting they could also assist in quitting smoking.

In summary, research supports the safety of the treatments in this trial—nicotine lozenges, nicotine patches, and smartphone support—in helping people stop smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for smoking cessation in people living with HIV because they bring a fresh approach to quitting smoking. Unlike standard treatments that often just involve nicotine patches and lozenges, the automated treatment arm incorporates digital support, like personalized videos and text content, delivered straight to your smartphone. This blend of traditional nicotine replacement with cutting-edge digital therapy offers a more engaging and accessible way to support individuals trying to quit smoking. By providing 24/7 access to personalized content, it aims to keep users motivated and supported throughout their quitting journey, which could lead to higher success rates compared to conventional methods.

What evidence suggests that this trial's treatments could be effective for smoking cessation in people living with HIV?

Research has shown that using a smartphone for automated treatment can help people with HIV quit smoking. In this trial, participants in the Automated Treatment arm will receive nicotine patches and lozenges, along with personalized video content and text messages. One study found that support delivered through cell phones led to higher rates of quitting smoking. Another study showed that a mobile app helped people quit by offering daily support and motivation. These tools aim to increase motivation and reduce stress, making it easier to quit smoking. Overall, early evidence suggests this approach can be effective for quitting smoking long-term. ^{6 7 8 9 10}

Who Is on the Research Team?

Damon J Vidrine, Dr.PH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for people living with HIV who currently smoke more than 5 cigarettes a day, have smoked at least 100 in their lifetime, and are ready to quit within a week of joining. Participants must own a smartphone compatible with the study app, speak English or Spanish, and have an email address. Pregnant or breastfeeding individuals, those on cessation meds or in another smoking study can't join.

Inclusion Criteria

You smoke more than 5 cigarettes per day.

I am willing to try quitting within a week of joining.

Process a smartphone compatible with the project app

Exclusion Criteria

Currently pregnant or breastfeeding

You are currently participating in a study to quit smoking.

I am currently using medication to help me stop smoking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 10-week supply of nicotine patches and lozenges, with weekly assessments and video content

10 weeks

Weekly electronic assessments

Follow-up

Participants are monitored for smoking abstinence and other outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Counseling
• Nicotine lozenge
• Nicotine patch
• Smartphone-delivered automated treatment

Trial Overview The study is testing if an Automated Video-Assisted Smoking Treatment using smartphones helps people stop smoking better than Standard Treatment that requires more resources. It involves nicotine patches, lozenges, counseling, and automated treatment delivered through a smartphone.

How Is the Trial Designed?

Group I: Automated Treatment Experimental Treatment 3 Interventions

Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content

Group II: Standard Treatment Active Control 3 Interventions

Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with their state's tobacco quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.

Nicotine lozenge is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Nicorette Lozenge for:

• Smoking cessation

Approved in Canada as Nicotrol Lozenge for:

• Smoking cessation

Approved in European Union as Nicorette Lozenge for:

• Smoking cessation

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8663670/

Evaluating the Efficacy of Automated Smoking Treatment ... This study will consist of a 2-group randomized controlled trial to evaluate a fully automated smartphone intervention for people with HIV seeking cessation ...

2. formative.jmir.org formative.jmir.org/2022/8/e28626/

A Smoking Cessation Mobile App for Persons Living With HIV Results: Of the 40 participants enrolled, 37 completed the follow-up study assessments and 16 used the app every day during the 56-day period.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21669958/

Efficacy of cell phone-delivered smoking cessation ... A smoking cessation intervention for PLWHA consisting of cell phone-delivered proactive counseling results in significantly higher abstinence rates.

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/390815

Ending Tobacco Use Through Interactive Tailored ... The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.

5. researchprotocols.org researchprotocols.org/2024/1/e52090/

An Integrated mHealth App for Smoking Cessation in Black ... This study aims to test a culturally adapted and novel mobile intervention that targets combustible cigarette smoking, HIV treatment engagement and adherence, ...

6. reference.medscape.com reference.medscape.com/drug/nicorette-lozenge-nicotine-lozenge-999318

nicotine lozenge (OTC) Smoking Cessation. Weeks 1-6: 1 lozenge q1-2hr. Weeks 7-9: 1 lozenge q2-4hr. Weeks 10-12: 1 lozenge q4-8hr. Do not exceed >5 lozenges/6hr.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/021330Orig1s021.pdf

APPLICATION NUMBER: NDA 21-330/S-21 Had a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C ...

8. nicorette.ca nicorette.ca/products/lozenge

NICORETTE® Smoking Cessation Lozenge Only to be used by adults who are trying to quit smoking. WARNING: This product contains nicotine. Nicotine is highly addictive. Flavours available. Mint.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03541044?term=AREA%5BBasicSearch%5D(NICOTINE%20POLACRILEX)&rank=7

A Bioequivalence Study of Two Nicotine Lozenges in ... This study will be a single center, randomized, open label, single dose, two-way crossover in healthy smokers that smoke their first cigarette more than 30 ...

10. haleonhealthpartner.com haleonhealthpartner.com/en-us/respiratory-health/brands/nicotine-replacement-therapy/nicorette-lozenges/safety-information/

Nicorette Lozenges Safety Information The Nicorette Lozenge was found to be well tolerated. 1 Safety was evaluated in a randomized, double-blind, placebo-controlled clinical trial over 52 weeks.