Smoking Cessation
Conditions
Brief summary
This study evaluates whether Automated Treatment performed better, in terms of facilitating long-term smoking abstinence, than the more resource-intensive Standard Treatment.
Interventions
DRUGNicotine patch
Participants were provided with a 10-week supply of nicotine patches.
BEHAVIORALCounseling
Phone counseling with the state tobacco quitline.
DRUGNicotine lozenge
Participants were provided with a 10-week supply of nicotine lozenges.
BEHAVIORALSmartphone-delivered automated treatment
An interactive smartphone-based intervention that comprised content delivered via audio/video clips and text content automatically each week for 12 weeks and on demand for 26 weeks to participants.
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 Point-Prevalence Smoking Abstinence | 12 Month Follow-Up | Participants who reported 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 biochemically verified smoking status by collecting cotinine samples via salivary cotinine kit. |
| Self Reported 24 Hours Smoking Abstinence | 12 Month Follow-Up | Number of participants who reported 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 reported no smoking, not even a puff, within the past 30 days. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDamon J Vidrine, Dr.PH
Moffitt Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 485 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 65 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 177 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 88 Participants |
| Race (NIH/OMB) More than one race | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants |
| Race (NIH/OMB) White | 244 Participants |
| Region of Enrollment United States | 512 participants |
| Sex: Female, Male Female | 81 Participants |
| Sex: Female, Male Male | 222 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