Tobacco Use Cessation
Conditions
Brief summary
This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.
Detailed description
The goals of this project include evaluating the feasibility, acceptability, and helpfulness of the real-time smoking intervention and to assess the preliminary efficacy of the real-time intervention as an adjunct to standard tobacco treatment. Rates of adherence, participant satisfaction, and perceived usefulness will be evaluated through post-treatment interviews and ratings. Biochemically confirmed 7-day point prevalence abstinence will be compared between the experimental and control groups at the end of treatment (week 8).
Interventions
BEHAVIORALReal-Time Smoking Intervention
Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
BEHAVIORALStandard Treatment
Adult smokers will receive standard outpatient tobacco treatment.
Sponsors
Patterson Trust Mentored Research Award: Clinical, Health Services and Policy Research
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel group randomized trial design comparing smoking outcomes when receiving standard treatment vs. standard treatment plus real-time smoking intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 or older * Able to read English * Cigarette smoker * Seeking smoking cessation treatment
Exclusion criteria
* Serious psychiatric or medical condition * Unable or unwilling to complete study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cigarettes | Baseline and Week 8 | Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Days Abstinent From Cigarettes | Week 8 | Timeline follow-back data will be collected to determine the % of days abstinent from cigarettes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Real-Time Smoking Intervention Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Real-Time Smoking Intervention: Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment. | 29 |
| Standard Treatment Adult smokers will receive standard outpatient tobacco treatment.
Standard Treatment: Adult smokers will receive standard outpatient tobacco treatment. | 29 |
| Total | 58 |
Baseline characteristics
| Characteristic | Real-Time Smoking Intervention | Total | Standard Treatment |
|---|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 10.3 | 56.0 years STANDARD_DEVIATION 9.9 | 57.9 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 46 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 14 Participants | 31 Participants | 17 Participants |
| Region of Enrollment United States | 29 participants | 58 participants | 29 participants |
| Sex: Female, Male Female | 17 Participants | 31 Participants | 14 Participants |
| Sex: Female, Male Male | 10 Participants | 23 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Change in Cigarettes
Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups.
Time frame: Baseline and Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real-Time Smoking Intervention | Change in Cigarettes | 10.2 cigarettes per day | Standard Deviation 12.2 |
| Standard Treatment | Change in Cigarettes | 7.7 cigarettes per day | Standard Deviation 6.5 |
Secondary
% Days Abstinent From Cigarettes
Timeline follow-back data will be collected to determine the % of days abstinent from cigarettes.
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real-Time Smoking Intervention | % Days Abstinent From Cigarettes | 12.4 percentage of days | Standard Deviation 27.2 |
| Standard Treatment | % Days Abstinent From Cigarettes | 6.9 percentage of days | Standard Deviation 14.6 |