Phase 4
Completed N=35
Engagement With an Adaptive Mobile Health Smoking Cessation Intervention
Tobacco Use Cessation
Source: ClinicalTrials.gov NCT04020718 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks — 0; 1; 1; 4 Participants
◆ Published Evidence
Emerging
3citations · ~1 / year
A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke.
Summary
This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.
Linked Publications
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A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Self-reported 7-day Abstinence From Smoking at 12 Weeks |
0; 1; 1; 4; 1; 0 | — |
| SECONDARY Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks |
0; 1; 2; 0; 0; 0 | — |
| SECONDARY Exhaled Carbon Monoxide Less Than 8 Parts Per Million |
8; 4; 1; 5; 6; 0 | — |
| SECONDARY Self-reported Number of Days Nicotine Lozenge and/or Patch Used |
5.8; 7.0 | — |
| SECONDARY Self-reported Change in Average Number of Cigarettes Smoked Per Day |
-7.0; -7.2; -13.0; -12.5; -4.7 | — |
Eligibility Criteria
Inclusion Criteria
- Adults (≥18 years)
- Smoking status of current smoker in structured field of electronic health record (EHR)
- Language listed as English in EHR
- Massachusetts General Hospital patient, Partners healthcare primary care provider (PCP)
- PCP visit in the past 2 years
- Mobile telephone number listed in EHR
Exclusion Criteria
- Not a current daily smoker defined as not having smoked ≥100 cigarettes in lifetime or self-report of less than daily current smoking
- Pregnant, planning to become pregnant in the next 3 months, or breastfeeding.
- Past 30-day use of nicotine replacement therapy, bupropion, or varenicline.
- Past 30-day use of Massachusetts state quit-line or SmokefreeTXT programs
- Prior serious adverse reaction to the nicotine patch or lozenge defined as any reaction that was life-threatening, required hospitalization, or other clinical evaluation
- Ever had an allergy to nicotine patch
- Weight < 100 pounds
- Unstable coronary disease
- Unstable arrhythmia
- Dementia or active psychosis or schizoaffective disorder
- Willing and able to receive and participate with a text message program for up to 12 weeks
- Unable to read English or unable to write English
Data sourced from ClinicalTrials.gov (NCT04020718) and the linked publication. 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.