Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers

H. Lee Moffitt Cancer Center and Research Institute

Status: Active, not recruiting

Conditions: Smoking Cessation

Treatments: Drug: Nicotine patch; Drug: Nicotine lozenge; Behavioral: Smartphone-delivered automated treatment; Behavioral: Counceling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05004662

MCC-20154

5R01CA231952-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 520 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• >100 lifetime cigarettes
• English or Spanish speaking
• Currently smoke > 5 cigarettes/day
• Process a smartphone compatible with the project app
• Have a valid email address

Exclusion criteria

• Currently pregnant or breastfeeding
• Current use of smoking cessation medications
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

520 participants in 2 patient groups

Standard Treatment

Active Comparator group

Description:

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.

Treatment:

Behavioral: Counceling

Drug: Nicotine lozenge

Drug: Nicotine patch

Automated Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Smartphone-delivered automated treatment

Drug: Nicotine lozenge

Drug: Nicotine patch