Smoking Cessation
Conditions
Brief 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.
Interventions
DRUGNicotine patch
Participants will be provided with a 10-week supply of nicotine patches
BEHAVIORALCounseling
Phone counseling with the state tobacco quitline.
DRUGNicotine lozenge
Participants will be provided with a 10-week supply of nicotine lozenges
BEHAVIORALSmartphone-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
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self Reported 7 Day Abstinence Smoking Status | 12 Month Follow-Up | Participants will self report 7-day abstinence smoking status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Status by Saliva Cotinine Kit | 12 Month Follow-Up | Investigators will verify smoking status by collecting cotinine sample from a saliva cotinine kit. |
| Self Reported 24 Hours Smoking Abstinence | 12 Month Follow-Up | Number of participants who report they quit smoking for 24 hours |
| 30 Day Smoking Abstinence | 12 Month Follow-Up | Number of participants who report they quit smoking for 30 days |
| Continuous Smoking Abstinence | 12 Month Follow-Up | Number of participants who report they quit smoking |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDamon J Vidrine, Dr.PH
Moffitt Cancer Center
Outcome results
None listed