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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

638 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if an automated system can help people quit smoking more effectively than traditional methods that require more resources.

Research Team

Damon J Vidrine, Dr.PH

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

I am currently using medication to help me stop smoking.

You are currently participating in a study to quit smoking.

Timeline

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

Treatment Details

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.

Participant Groups

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+