Pilot Randomized Controlled Trial of a Smart Phone-Based Smoking Cessation Program

NCT04955639 | Completed Results FDA Device

• 1 other identifier: C-650
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Average Total App Openings at 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.

  12 weeks

Secondary Outcomes (32)

• Desire to Quit (Yes/no)

  4 weeks

• Change in Expected Difficulty in Staying Quit

  12 weeks

• Change in Confidence Levels Towards Quitting Smoking

  12 weeks

• Self-Reported Smoking Abstinence

  12 weeks

• Self-Reported Smoking Abstinence

  26 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

A commercially available mobile phone app and program

Other: Control

Pivot

ACTIVE COMPARATOR

Pivot mobile phone app and program

Other: Pivot

Interventions

Control OTHER

Standard of Care - Control Smoking Cessation Program

Also known as: Standard of Care

Control

Pivot OTHER

Pivot Program Smoking Cessation Program

Also known as: Pivot Program

Pivot

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jennifer Marler, MD: lead

Study Sites (1)

Pivot Health Technologies, Inc.

San Carlos, California, 94070, United States

Location

Related Publications (2)

• Marler JD, Fujii CA, Utley MT, Balbierz DJ, Galanko JA, Utley DS. Long-Term Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Sep 18;11:e48157. doi: 10.2196/48157.

  PMID: 37585282 DERIVED

• Marler JD, Fujii CA, Utley MT, Balbierz DJ, Galanko JA, Utley DS. Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Nov 24;10(11):e41658. doi: 10.2196/41658.

  PMID: 36257323 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Craig Fujii, Sr. Director of Clinical Affairs and Data Science
• Organization: Pivot Health Technologies Inc.

craig@pivot.co

650-906-4255

Study Officials

• Jennifer Marler, MD

  Pivot Health Technologies Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant blinded to arm assignment but not to the smoking cessation program he/she is using.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sr. Dir., Clinical and Medical Affairs

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 9, 2021
• Study Start: June 3, 2021
• Primary Completion: April 27, 2022
• Study Completion: November 17, 2023
• Last Updated: July 1, 2024
• Results First Posted: January 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)