N/A
Completed N=188
Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program
Source: ClinicalTrials.gov NCT04955639 ↗Enrolled (actual)
188
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: Average Total App Openings at 12 Weeks — 86.5; 157.9 app openings
Summary
Two-arm, parallel-group, non-crossover, single-center pilot randomized controlled trial, enrolling up to 180 participants to evaluate the effect of the Pivot smoking cessation program (intervention) compared to usual care (commercially available app smoking cessation program plus optional nicotine replacement therapy, control).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Total App Openings at 12 Weeks |
86.5; 157.9 | — |
| SECONDARY Desire to Quit (Yes/no) |
88; 91; 0; 0 | — |
| SECONDARY Change in Expected Difficulty in Staying Quit |
5.2; 5.7; 1.7; 2.2 | — |
| SECONDARY Change in Confidence Levels Towards Quitting Smoking |
5.8; 6.6; 1.6; 2.0 | — |
| SECONDARY Self-Reported Smoking Abstinence |
29; 39; 29; 39; 28; 34 | — |
| SECONDARY Self-Reported Abstinence From All Tobacco Products |
27; 33; 27; 33 | — |
| SECONDARY Biochemically Confirmed Abstinence |
17; 29; 17; 29 | — |
| SECONDARY Self-Reported Continuous Abstinence |
8; 19; 8; 19 | — |
| SECONDARY Biochemically Confirmed Continuous Abstinence |
8; 18; 8; 18 | — |
| SECONDARY Proportion With ≥ 50% CPD Reduction |
59; 56 | — |
| SECONDARY User Satisfaction - User Feedback |
54; 72; 35; 19; 3; 1 | — |
| SECONDARY Additional User Feedback |
51; 72; 26; 16; 12; 1 | — |
| SECONDARY User Feedback - Setup and Starting the Program |
7.1; 8.2 | — |
| SECONDARY User Feedback |
69; 79; 22; 34 | — |
| SECONDARY User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking |
26; 35 | — |
| SECONDARY User Satisfaction - Net Promoter Score (NPS) |
1.1; 50.6; 11.0; 44.6; 23.6; 57.8 | — |
| SECONDARY Engagement With Program - Number of Times App Was Opened |
86.5; 157.9 | — |
| SECONDARY Engagement With Program - Number of Days App Was Opened |
50.4; 49.6 | — |
| SECONDARY Engagement With Program - Number of Weeks App Was Opened |
11.0; 11.0 | — |
| SECONDARY Participant Changes in Self-Efficacy |
12.6; 14.9; 1.0; 3.2 | — |
| SECONDARY Participant Changes in Self-reported Health and Wellbeing |
1; 4; 33; 24; 48; 51 | — |
| SECONDARY Self-Reported Nicotine Replacement Therapy (NRT) Use |
9; 22; 57; 42; 14; 29 | — |
| SECONDARY Adverse Events |
0; 0; 17; 19 | — |
Eligibility Criteria
Inclusion Criteria
- 21+ years of age
- Current daily cigarette smokers (at least 5 cigarettes per day) for the past 12 months
- Plans to quit smoking in the next 30 days
- Resident of the United States
- Able to read and comprehend English
- Owns and uses a smart phone compatible with the study app (iPhone 5 and above with operating system (iOS) 12 and above, or, Android 7.0 and above with operating system Android 7.0 and above)
- Has daily internet access on smart phone
- Comfortable downloading and using smart phone apps
- Willing to sign the Informed Consent Form
Exclusion Criteria
- Pregnancy (self-reported)
- Health contraindications to nicotine replacement therapy (NRT) use (irregular heartbeat, high blood pressure not controlled with medication, heart attack or stroke in last 2 months, pregnant or breast feeding, skin allergies to adhesive tape or serious skin problems, stomach ulcers, history of seizures)
- Using other smoking cessation support, including apps and/or actively taking medication to quit smoking
- Daily marijuana use
- Residence with another person who is a participant in this study
- Immediate family member is a participant in this study
- Failure to provide contact or collateral information, failure to verify email address, and/or failure to demonstrate videoconference capability
- Participation in a previous study sponsored by Carrot Inc.
Data sourced from ClinicalTrials.gov (NCT04955639). 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.