520 Participants Needed

Comprehensive Tobacco Treatment for Smoking Cessation

KB
SR
JI
SS
Overseen BySteven Sutton, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

DJ

Damon J Vidrine, Dr.PH

Principal Investigator

Moffitt Cancer Center

JI

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
See 1 more

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
See 2 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Automated TreatmentExperimental Treatment3 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 TreatmentActive Control3 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:

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Approved in United States as Nicorette Lozenge for:
  • Smoking cessation
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Approved in Canada as Nicotrol Lozenge for:
  • Smoking cessation
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Approved in European Union as Nicorette Lozenge for:
  • Smoking cessation

Find a Clinic Near You

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+
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