Automated Smoking Cessation for People Living With HIV

Recruiting in Palo Alto (17 mi)

Overseen by Damon J Vidrine, Dr.PH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

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.

Treatment Details

Interventions

• Counseling (Behavioural Intervention)
• Nicotine lozenge (Nicotine Replacement Therapy)
• Nicotine patch (Nicotine Replacement Therapy)
• Smartphone-delivered automated treatment (Behavioural Intervention)

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 Canada for the following indications:

Approved in Canada as Nicotrol 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+

Patrick Hwu

H. Lee Moffitt Cancer Center and Research Institute

Chief Executive Officer since 2020

MD from The Medical College of Pennsylvania

Wade J. Sexton

H. Lee Moffitt Cancer Center and Research Institute

Chief Medical Officer

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School