Nicotine Dependence, Cigarettes
Conditions
Brief summary
This study is evaluating the feasibility and short term smoking cessation outcomes of an automated smoking cessation intervention delivered via mobile phone text messaging as an adjunct to Varenicline in a primary care setting.
Interventions
BEHAVIORALMotivational Text Messages
Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
BEHAVIORALControl
Usual Care. All participants receive the active medication, Varenicline.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Smoke \>4 cigarettes/day for at least 6 months * Age 21+ * Want to quit and ready to try in next 30 days * Willing to quit all forms of tobacco (including e-cigs) * Willing to use Chantix to try to quit * Have a cell phone able to receive text messages * Willing to attend 3 visits and use varenicline for smoking cessation * Plan to live in local area for next 6 months * Read and write in English * Women not pregnant and taking steps to avoid * Able to understand and willing to sign consent
Exclusion criteria
* History of allergic reaction or other adverse event while using varenicline * Used a smoking cessation aid/medicine in past 1 month (including e-cigs) * Currently pregnant or nursing * Does not have a mobile phone that can send and receive text messages or unwilling to receive study texts * Uncontrolled serious mental illness or substance abuse or inpatient treatment for these in the past 6 months * Uses non-cigarette tobacco products and does not plan to quit all tobacco. * Has a history of kidney problems or receives dialysis * Had any thoughts that they would be better off dead or of deliberate self-harm in the prior 4 weeks * Had a heart attack in the past 4 weeks * Mental conditions that would prohibit the participant from completing the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) | 12 weeks | — |
| Sustained Abstinence at the 12-week Follow up | 12 weeks | — |
| Number of Days of Varenicline Use | 12 weeks | — |
| Number of Active Smoking Cessation Activities Used | 12 weeks | Number of activities completed out of 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time (in Days) to Relapse After the Target Quit Day | 12 weeks | — |
| Total Score on the Positive Smoking Cessation Activities Measure | 12 weeks | Total score for 6 items (scored 0-3). Total score range 0-18. |
| Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3. | 12 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motivational Text Messages Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline. | 74 |
| Control Control: Usual Care. All participants receive the active medication, Varenicline. | 76 |
| Total | 150 |
Baseline characteristics
| Characteristic | Motivational Text Messages | Total | Control |
|---|---|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 12.3 | 45.5 years STANDARD_DEVIATION 11.9 | 44.5 years STANDARD_DEVIATION 11.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 65 Participants | 131 Participants | 66 Participants |
| Region of Enrollment United States | 74 participants | 150 participants | 76 participants |
| Sex: Female, Male Female | 45 Participants | 99 Participants | 54 Participants |
| Sex: Female, Male Male | 29 Participants | 51 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 74 | 33 / 76 |
| serious Total, serious adverse events | 1 / 74 | 2 / 76 |
Outcome results
Primary
Number of Active Smoking Cessation Activities Used
Number of activities completed out of 6
Time frame: 12 weeks
Population: This data is presented for only participants who showed to Visit 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Text Messages | Number of Active Smoking Cessation Activities Used | 4.5 activities | Standard Deviation 1.3 |
| Control | Number of Active Smoking Cessation Activities Used | 4.0 activities | Standard Deviation 1.5 |
Primary
Number of Days of Varenicline Use
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Text Messages | Number of Days of Varenicline Use | 55.4 days | Standard Deviation 37.2 |
| Control | Number of Days of Varenicline Use | 55.7 days | Standard Deviation 35.5 |
Primary
Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Text Messages | Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) | 23 Participants |
| Control | Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) | 23 Participants |
Primary
Sustained Abstinence at the 12-week Follow up
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Text Messages | Sustained Abstinence at the 12-week Follow up | 6 Participants |
| Control | Sustained Abstinence at the 12-week Follow up | 9 Participants |
Secondary
Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Text Messages | Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3. | 6 Participants |
| Control | Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3. | 9 Participants |
Secondary
Time (in Days) to Relapse After the Target Quit Day
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Text Messages | Time (in Days) to Relapse After the Target Quit Day | 16.0 days | Standard Deviation 28.9 |
| Control | Time (in Days) to Relapse After the Target Quit Day | 16.5 days | Standard Deviation 30.6 |
Secondary
Total Score on the Positive Smoking Cessation Activities Measure
Total score for 6 items (scored 0-3). Total score range 0-18.
Time frame: 12 weeks
Population: This data is presented for only participants who showed to Visit 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Text Messages | Total Score on the Positive Smoking Cessation Activities Measure | 10.5 activities | Standard Deviation 3.8 |
| Control | Total Score on the Positive Smoking Cessation Activities Measure | 9.1 activities | Standard Deviation 4.2 |