Smoking Cessation
Conditions
Brief summary
This study will evaluate the efficacy and economic impact of a theoretically-based, fully automated, interactive smartphone-based smoking cessation intervention.
Interventions
BEHAVIORALSmartphone-delivered automated treatment
An interactive smartphone-based intervention that comprises content delivered via audio/video clips and text content automatically each week for 12 weeks and on demand for 26 weeks to participants
DRUGNicotine patch
Participants will be provided with a 10-week supply of nicotine patches
BEHAVIORALCounseling
Smoking cessation treatment delivery by State Quitline's
DRUGNicotine lozenge
Participants will be provided with a 10-week supply of nicotine lozenges
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
Yes
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 * Receipt of food assistance in the past 3 month
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported 7-Day Point-Prevalence Smoking Abstinence | 12 Month Follow-Up | Participants who report no smoking, not even a puff, within the past 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical Verification Via Salivary Cotinine | 12 Month Follow-Up | Investigators will biochemically verify smoking status by collecting cotinine samples via salivary cotinine kit |
| Self-Reported 24-Hour Point-Prevalence Smoking Abstinence | 12 Month Follow-Up | Number of participants who report no smoking, not even a puff, within the past 24 hours |
| Self-Reported 30-Day Point-Prevalence Smoking Abstinence | 12 Month Follow-Up | Number of participants who report no smoking, not even a puff, within the past 30 days |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDamon J Vidrine, Dr.PH
Moffitt Cancer Center
PRINCIPAL_INVESTIGATORJennifer I Vidrine, Ph.D.
Moffitt Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 467 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 226 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 41 Participants |
| Race (NIH/OMB) More than one race | 23 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 374 Participants |
| Region of Enrollment United States | 499 participants |
| Sex: Female, Male Female | 364 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed