21 and older, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Average Total App Openings at 12 WeeksPrimary· 12 weeks
App/program engagement is assessed with the self-report of total app openings through the first 12 weeks of the program. Calculated by summing the number of weekly app openings reported by participants weekly.
Group
Value
95% CI
Control
86.5
± 66.3
Pivot
157.9
± 210.6
Desire to Quit (Yes/no)Secondary· 4 weeks
desire to quit smoking, participant self-report, yes/no
Participants who answered "yes" to having a desire to quit smoking
Group
Value
95% CI
Control
88
Pivot
91
Participants who answered "no" to having a desire to quit smoking
Group
Value
95% CI
Control
0
Pivot
0
Change in Expected Difficulty in Staying QuitSecondary· 12 weeks
Expected difficulty to stay quit from smoking. Participants asked: "How difficult do you think it would be to stay smoke free?". Participant self-report on scale 1-10 (1=Really hard to stay quit, 10=Really easy to stay quit)
Difficulty to quit 12 weeks
Group
Value
95% CI
Control
5.2
± 3.0
Pivot
5.7
± 3.1
Change in Difficulty to quit from baseline to 12 weeks
Group
Value
95% CI
Control
1.7
± 3.4
Pivot
2.2
± 3.7
Change in Confidence Levels Towards Quitting SmokingSecondary· 12 weeks
Expected success in quitting smoking. Asked: " If you were to quit smoking right now, how successful would you be?". Participant self-report, scale 1-10 (1=Not at all successful, 10=Completely successful).
Success to quit 12 weeks
Group
Value
95% CI
Control
5.8
± 3.1
Pivot
6.6
± 3.0
Change in Success to quit from baseline to 12 weeks
Participants who report they have achieved at least 7-day point prevalence abstinence at 12 weeks will undergo a videoconference visit with study staff in which they provide a witnessed breath sample using a provided personal mobile carbon monoxide breath sensor. Breath sample values less than 10 ppm (parts per million) will be considered consistent with biochemical abstinence.
Participants who report they have achieved at least 7-day point prevalence abstinence at 26 weeks will undergo a videoconference visit with study staff in which they provide a witnessed breath sample using a provided personal mobile carbon monoxide breath sensor. Breath sample values less than 10 ppm (parts per million) will be considered consistent with biochemical abstinence.
Biovalidated abstinence ITT
Group
Value
95% CI
Control
14
Pivot
26
Biovalidated abstinence Responder
Group
Value
95% CI
Control
14
Pivot
26
Adverse events — posted to ClinicalTrials.gov
Time frame: Participants self-report adverse event experienced due to their assigned program and/or the NRT that they ordered during the study. Participants were asked at 12 weeks and 26 weeks if they had any issues with their assigned program and/or with their use of nicotine replacement therapy..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Control
Serious: 0/94 (0%)
Deaths: 0/94
Pivot
Serious: 0/94 (0%)
Deaths: 0/94
Other adverse events (8 terms — click to expand)
Reaction
System
Control
Pivot
Skin irritation due to NRT patch use
Skin and subcutaneous tissue disorders
—
—
GI upset due to NRT lozenge or gum use
Gastrointestinal disorders
—
—
Heartburn due to NRT lozenge or gum use
Gastrointestinal disorders
—
—
Sleep issues - wild dreams, insomnia
General disorders
—
—
Hiccups due to NRT lozenge or gum use
Gastrointestinal disorders
—
—
Jittery, racing heart, or lightheaded feeling due to NRT use
General disorders
—
—
Headache due to NRT use
General disorders
—
—
Mouth irritation or sore throat due to NRT lozenge or gum use
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06064604 — Clinical Efficacy of Exoskeleton Assistance for Individuals Post-Stroke
· NA
· not yet recruiting
NCT04039386 — Psychosocial Interventions for Young Adults With Hip Pain
· NA
· not yet recruiting
NCT07042373 — Effects of Tobacco Abuse Liability-dependent Taxes in the ETM
· NA
· not yet recruiting
NCT07512999 — The Effect of Using Nature Sounds and Virtual Reality During the Non-Stress Test
· NA
· not yet recruiting
NCT07531563 — Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy
· NA
· not yet recruiting
Other recruiting trials for Smoking Cessation
Currently open trials in the same condition.
NCT07420621 — Preliminary Effectiveness of Enhanced Text Message + Incentives
· NA
· recruiting
NCT07224087 — Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
· Phase 1
· recruiting
NCT07331519 — Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer
· NA
· recruiting
NCT07210567 — Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors
· NA
· recruiting
NCT07129590 — Trauma-Informed Care for Smoking Cessation for Pregnancy
· NA
· recruiting
Other Jennifer Marler, MD trials
Trials by the same sponsor.
NCT04133064 — Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study
· NA
· completed
NCT03870022 — Pivot Breath Sensor Performance Study
· NA
· completed
NCT03835260 — Pivot Breath Sensor Human Factors and Usability Study
· NA
· completed
NCT03295643 — Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months
· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jennifer Marler, MD
Last refreshed: 1 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04955639.