Comprehensive Tobacco Treatment for Smoking Cessation

Overseen By Steven Sutton, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Smoking cessation medications

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

520 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention.

Research Team

Damon J Vidrine, Dr.PH

Principal Investigator

Moffitt Cancer Center

Jennifer Vidrine, PhD, MS

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for English or Spanish speakers who currently smoke more than 5 cigarettes a day, are willing to try quitting within a week of joining, have smoked over 100 cigarettes in their lifetime, own a smartphone compatible with the study's app and have an email address. Pregnant or breastfeeding individuals, those on smoking cessation meds, enrolled in another cessation study or living with someone in this study can't join.

Inclusion Criteria

>100 lifetime cigarettes

I have a working email address.

Process a smartphone compatible with the project app

Exclusion Criteria

Enrolled in a smoking cessation study

Household member enrolled in the study

Failure to electronically confirm participation with 14 days of randomization via electronic link sent to participant's smartphone

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 smartphone assessments

10 weeks

Weekly electronic assessments

Follow-up

Participants are monitored for smoking abstinence and other outcomes

12 months

Treatment Details

Interventions

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

Trial Overview The trial is testing how well and cost-effectively a smartphone app helps people quit smoking compared to other methods. Participants will receive automated treatment through the app along with nicotine patches or lozenges and counseling support.

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 Florida 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+