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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05014282
Other study ID # MCC-20262
Secondary ID R01CA243552
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2021
Est. completion date March 31, 2025

Study information

Verified date March 2024
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Sarah R Jones
Phone 813-745-7525
Email Sarah.Jones@moffitt.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate if Automated Treatment performs better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date March 31, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - smoked >/=100 cigarettes in lifetime - English or Spanish speaking - Currently smoke > 5 cigarettes/day - Willing to make a quit attempt within 1 week of enrollment - HIV positive - 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 within 14 days of randomization via electronic link sent to participant's smartphone

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nicotine patch
Participants will be provided with a 10-week supply of nicotine patches
Behavioral:
Counseling
Phone counseling with the state tobacco quitline.
Drug:
Nicotine lozenge
Participants will be provided with a 10-week supply of nicotine lozenges
Behavioral:
Smartphone-delivered automated treatment
An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week to the participant

Locations

Country Name City State
United States Moffitt Cancer Center Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self Reported 7 Day Abstinence Smoking Status Participants will self report 7-day abstinence smoking status 12 Month Follow-Up
Secondary Smoking Status by Saliva Cotinine Kit Investigators will verify smoking status by collecting cotinine sample from a saliva cotinine kit. 12 Month Follow-Up
Secondary Self Reported 24 Hours Smoking Abstinence Number of participants who report they quit smoking for 24 hours 12 Month Follow-Up
Secondary 30 Day Smoking Abstinence Number of participants who report they quit smoking for 30 days 12 Month Follow-Up
Secondary Continuous Smoking Abstinence Number of participants who report they quit smoking 12 Month Follow-Up
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