---
title: Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program
nct_id: NCT04955639
overall_status: COMPLETED
phase: NA
sponsor: Jennifer Marler, MD
study_type: INTERVENTIONAL
primary_condition: Smoking Cessation
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04955639.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04955639"
ct_last_update_post_date: 2024-07-01
last_seen_at: "2026-05-12T06:27:49.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program

**NCT ID:** [NCT04955639](https://clinicaltrials.gov/study/NCT04955639)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 188
- **Lead Sponsor:** Jennifer Marler, MD
- **Conditions:** Smoking Cessation
- **Start Date:** 2021-06-03
- **Completion Date:** 2023-11-17
- **CT.gov Last Update:** 2024-07-01

## Brief 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).

## Detailed Description

The present pilot randomized controlled trial compares user engagement and retention, change in attitudes towards quitting smoking, change in smoking behavior and participant feedback in adult smokers randomized either to the Pivot (intervention) or commercially available (control) smoking cessation programs.

We aim to assess participants' use of Pivot program and commercially available program. There will be a focus on assessing use and engagement, changes in attitudes towards quitting smoking and changes in smoking behavior over the course of the 2-year study, as well as participant feedback on the set-up, design, use experience, and impact of each program.

## Eligibility

- **Minimum age:** 21 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **Control** (ACTIVE_COMPARATOR) — A commercially available mobile phone app and program
- **Pivot** (ACTIVE_COMPARATOR) — Pivot mobile phone app and program

## Interventions

- **Control** (OTHER) — Standard of Care - Control Smoking Cessation Program
- **Pivot** (OTHER) — Pivot Program Smoking Cessation Program

## Primary Outcomes

- **Average Total App Openings at 12 Weeks** _(time frame: 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.

## Secondary Outcomes

- **Desire to Quit (Yes/no)** _(time frame: 4 weeks)_
- **Change in Expected Difficulty in Staying Quit** _(time frame: 12 weeks)_
- **Change in Confidence Levels Towards Quitting Smoking** _(time frame: 12 weeks)_
- **Self-Reported Smoking Abstinence** _(time frame: 12 weeks)_
- **Self-Reported Smoking Abstinence** _(time frame: 26 weeks)_
- **Self-Reported Smoking Abstinence** _(time frame: 52 weeks)_
- **Self-Reported Abstinence From All Tobacco Products** _(time frame: 12 weeks)_
- **Self-Reported Abstinence From All Tobacco Products** _(time frame: 26 weeks)_
- **Self-Reported Abstinence From All Tobacco Products** _(time frame: 52 weeks)_
- **Biochemically Confirmed Abstinence** _(time frame: 12 weeks)_
- **Biochemically Confirmed Abstinence** _(time frame: 26 weeks)_
- **Biochemically Confirmed Abstinence** _(time frame: 52 weeks)_
- **Self-Reported Continuous Abstinence** _(time frame: 26 weeks)_
- **Self-Reported Continuous Abstinence** _(time frame: 52 weeks)_
- **Biochemically Confirmed Continuous Abstinence** _(time frame: 26 weeks)_
- **Biochemically Confirmed Continuous Abstinence** _(time frame: 52 weeks)_
- **Proportion With ≥ 50% CPD Reduction** _(time frame: 26 weeks)_
- **User Satisfaction - User Feedback** _(time frame: 2 weeks)_
- **Additional User Feedback** _(time frame: 3 weeks)_
- **User Feedback - Setup and Starting the Program** _(time frame: 12 weeks)_
- **User Feedback** _(time frame: 26 weeks)_
- **User Feedback: Number of Participants Who Agreed That Their Program Helped Them Quit Smoking** _(time frame: 52 weeks)_
- **User Satisfaction - Net Promoter Score (NPS)** _(time frame: 4 weeks, 12 weeks, and 26 weeks)_
- **Engagement With Program - Number of Times App Was Opened** _(time frame: 12 weeks)_
- **Engagement With Program - Number of Days App Was Opened** _(time frame: 12 weeks)_
- **Engagement With Program - Number of Weeks App Was Opened** _(time frame: 12 weeks)_
- **Participant Changes in Self-Efficacy** _(time frame: 12 weeks)_
- **Participant Changes in Self-Efficacy** _(time frame: 52 weeks)_
- **Participant Changes in Self-reported Health and Wellbeing** _(time frame: 12 weeks)_
- **Self-Reported Nicotine Replacement Therapy (NRT) Use** _(time frame: 26 weeks)_
- **Self-Reported Nicotine Replacement Therapy (NRT) Use** _(time frame: 52 weeks)_
- **Adverse Events** _(time frame: 12 weeks)_

## Locations (1)

- Pivot Health Technologies, Inc., San Carlos, California, United States

## Recent Field Changes (last 30 days)

- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `locations.pivot health technologies, inc.|san carlos|california|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04955639.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04955639*  
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