N/A
Completed N=152
Penn State TXT2Quit Study
Nicotine Dependence, Cigarettes
Source: ClinicalTrials.gov NCT02367391 ↗
Enrolled (actual)
152
Serious AEs
2.0%
Results posted
Mar 2017
Primary outcomePrimary: Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) — 23; 23 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day) |
23; 23 | — |
| PRIMARY Sustained Abstinence at the 12-week Follow up |
6; 9 | — |
| PRIMARY Number of Days of Varenicline Use |
55.4; 55.7 | — |
| PRIMARY Number of Active Smoking Cessation Activities Used |
4.5; 4.0 | — |
| SECONDARY Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3. |
6; 9 | — |
| SECONDARY Time (in Days) to Relapse After the Target Quit Day |
16.0; 16.5 | — |
| SECONDARY Total Score on the Positive Smoking Cessation Activities Measure |
10.5; 9.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02367391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.