Tobacco Use DisorderPhase 1NCT04560868

Development of a mHealth Intervention for Ambivalent Smokers

A Phase 1 study testing Experimental mHealth program and Nicotine patch in people with Tobacco Use Disorder and Smoking Cessation, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The current pilot study will assess the feasibility and acceptability of a novel mHealth app designed for people who are ambivalent about quitting smoking. Results will be used to refine the intervention and plan for a future randomized effectiveness trial. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Tobacco Use Disorder, Smoking Cessation, Motivation
What is being tested?: Experimental mHealth program and Nicotine patch
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 1 siteUnited States
Study dates: 16 Dec 2020to 27 Sep 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years or older;
Can speak/read English;
Current smoker;
Own and regularly use an eligible smartphone;
No vision impairments;
Willing to install and use the study program;

Show all 9Show fewer

Willing to use birth control if elect to use nicotine replacement during the study (females);
Meet definition for ambivalence
Not actively using treatment

Who cannot join

Smoke less than 10 cigarettes per day
Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia;
Have medical contraindications for nicotine replacement therapy;
Another household member is enrolled in the study
Unable to verify contact information
Fail to install app

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101

Other trials in United States

About this study

Conditions: Tobacco Use Disorder, Smoking Cessation, Motivation, Behavior, Smoking
Being tested: Control mHealth program, Experimental mHealth program, Nicotine patch
Keywords: mHealth, smoking, smoking cessation, motivation
Medical subject headings: Tobacco Use Disorder, Smoking Cessation, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Control mHealth programDevice
The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
Experimental mHealth programDevice
The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
Nicotine patchDrug
Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.

Study groups in NCT04560868
Study group	Role	What they receive
Control	Active comparator	Not described Receives: Device: Control mHealth program; Drug: Nicotine patch
Experimental	Experimental	Not described Receives: Device: Experimental mHealth program; Drug: Nicotine patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Program Engagement
Number of unique app user-sessions
Measured: Assessed at 3-month follow-up
Quit Attempt Lasting at Least 24 Hours
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
Measured: Assessed at 3-month follow-up
Not Smoking (Even a Puff) in the Last 7 Days
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.
Measured: Assessed at 3-month follow-up

Secondary outcomes (16)

Satisfaction With Assigned App
Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
Measured: Assessed at 1 month
Satisfaction With Assigned App
Satisfaction with the overall "content and advice" of the assigned app on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".
Measured: Assessed at 3 months
Helpfulness of Assigned App
Global helpfulness rating calculated as the average helpfulness rating of 8 app features, each rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".
Measured: Assessed at 1 month.
Helpfulness of Assigned App
Average helpfulness rating of 8 separate app features, with each feature rated on a Likert scale from 1="not at all helpful" to 5="extremely helpful".
Measured: Assessed at 3 months
Program Engagement - Earned Badges
Number of accumulated badge rewards earned from using the assigned app.
Measured: Assessed at 1-month follow-up
Program Engagement - Earned Badges
Number of accumulated badge rewards earned from using the assigned app.
Measured: Assessed at 3-month follow-up
Self-efficacy to Quit Smoking
Self-reported confidence in quitting smoking on Likert scale from 1="not at all" to 10="extremely".
Measured: Assessed at 1 month
Self-efficacy to Quit Smoking
Self-reported confidence in quitting smoking on a Likert scale from 1="not at all" to 10="extremely".
Measured: Assessed at 3 months
Self-efficacy to Stay Quit
Self-reported confidence in ability to stay quit on a Likert scale from 1="not at all" to 10="extremely".
Measured: Assessed at 1 month
Self-efficacy to Stay Quit
Self-reported confidence in ability to stay quit (if no smoking in the past 7 days) on a Likert scale from 1="not at all" to 10="extremely".
Measured: Assessed at 3 months
Earned and Requested Free Nicotine Replacement Therapy
Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Measured: Assessed at 1-month follow-up
Earned and Requested Free Nicotine Replacement Therapy
Earned and requested free nicotine replacement therapy (NRT); free NRT could be earned by earning 6 app utilization badges.
Measured: Assessed at 3-month follow-up
Quit Attempt Lasting at Least 24 Hours
At least one intentional smoking quit attempt lasting at least 24 hours; non-respondents were assumed to not have a successful quit attempt.
Measured: Assessed at 1 month follow-up
Change in Cigarettes/Day
Change in number of cigarettes smoked per day from baseline, calculated as (1 month)-baseline.
Measured: Assessed at baseline and 1 month
Change in Cigarettes/Day
Change in number of cigarettes smoked per day from baseline, calculated as (3 months)-baseline.
Measured: Assessed at baseline and 3 months
Refrain From Smoking (Even a Puff) in the Last 7 Days
7-day point prevalent abstinence: a self-report of not smoking, even a puff, in the past 7 days. Missing outcomes were imputed as smoking.
Measured: Assessed at 1-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 202027 Sep 2021

First posted23 Sep 2020
Study start16 Dec 2020
Primary completion27 Sep 2021
Study completion27 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Device feasibility
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04560868
Sponsor's protocol ID: 1401452
Other IDs: R21CA234003
Status last verified: Jan 2023
First submitted: 15 Jun 2020
Last updated: 23 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will not be shared.

Publications

McClure JB, Heffner JL, Krakauer C, Mun S, Klasnja P, Catz SL. Feasibility, Acceptability, and Potential Impact of a Novel mHealth App for Smokers Ambivalent About Quitting: Randomized Pilot Study. JMIR Mhealth Uhealth. 2023 Jun 28;11:e46155. doi: 10.2196/46155.
PubMed 37379059

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus

All Tobacco Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of a mHealth Intervention for Ambivalent Smokers
ClinicalTrials.gov ID: NCT04560868
Acronym / sponsor ID: 1401452
Conditions: Tobacco Use Disorder, Smoking Cessation, Motivation, Behavior, Smoking
Keywords: mHealth, smoking, smoking cessation, motivation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 16 Dec 2020 (actual)
Primary completion: 27 Sep 2021 (actual)
Study completion: 27 Sep 2021 (actual)
First posted: 23 Sep 2020 (actual)
Results: Posted 23 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Device feasibility
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control	Active comparator	Device: Control mHealth program, Drug: Nicotine patch
Experimental	Experimental	Device: Experimental mHealth program, Drug: Nicotine patch

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

18 years or older;
Can speak/read English;
Current smoker;
Own and regularly use an eligible smartphone;
No vision impairments;

Key exclusion criteria (6 listed)

Smoke less than 10 cigarettes per day
Self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia;
Have medical contraindications for nicotine replacement therapy;
Another household member is enrolled in the study
Unable to verify contact information

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Control mHealth programThe intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.	Device	Control
Experimental mHealth programThe intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.	Device	Experimental
Nicotine patchParticipants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.	Drug	Control, Experimental

Primary outcome

Program Engagement
Time frame: Assessed at 3-month follow-up
Number of unique app user-sessions
Quit Attempt Lasting at Least 24 Hours
Time frame: Assessed at 3-month follow-up
At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.
Not Smoking (Even a Puff) in the Last 7 Days
Time frame: Assessed at 3-month follow-up
7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.

16 secondary outcomes

Satisfaction With Assigned App
Time frame: Assessed at 1 month
Satisfaction With Assigned App
Time frame: Assessed at 3 months
Helpfulness of Assigned App
Time frame: Assessed at 1 month.
Helpfulness of Assigned App
Time frame: Assessed at 3 months
Program Engagement - Earned Badges
Time frame: Assessed at 1-month follow-up
Program Engagement - Earned Badges
Time frame: Assessed at 3-month follow-up
Self-efficacy to Quit Smoking
Time frame: Assessed at 1 month
Self-efficacy to Quit Smoking
Time frame: Assessed at 3 months
Self-efficacy to Stay Quit
Time frame: Assessed at 1 month
Self-efficacy to Stay Quit
Time frame: Assessed at 3 months
Earned and Requested Free Nicotine Replacement Therapy
Time frame: Assessed at 1-month follow-up
Earned and Requested Free Nicotine Replacement Therapy
Time frame: Assessed at 3-month follow-up
Quit Attempt Lasting at Least 24 Hours
Time frame: Assessed at 1 month follow-up
Change in Cigarettes/Day
Time frame: Assessed at baseline and 1 month
Change in Cigarettes/Day
Time frame: Assessed at baseline and 3 months
Refrain From Smoking (Even a Puff) in the Last 7 Days
Time frame: Assessed at 1-month follow-up

Results and safety

Results posted to the registry on 23 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	29	29
Experimental	28	28

Primary outcome: Program Engagement

Time frame: Assessed at 3-month follow-up. Mean (Standard Deviation). Unit: User sessions

Measure	Control n = 29	Experimental n = 28
Value	7.3 (6.6)	19.9 (16.2)

Control vs Experimental: Mean Difference (Final Values): 12.73 (95% CI 6.41 to 19.05), p <0.01, Regression, Linear

Population analysed: All individuals who installed the app (n = 57).

Primary outcome: Quit Attempt Lasting at Least 24 Hours

Time frame: Assessed at 3-month follow-up. Count of participants. Unit: Participants

Measure	Control n = 29	Experimental n = 28
Value	11	11

Control vs Experimental: Risk Ratio (RR): 1.01 (95% CI 0.55 to 1.85), p = 0.98, Regression, Poisson

Population analysed: All individuals who installed the app (n = 57).

Primary outcome: Not Smoking (Even a Puff) in the Last 7 Days

Time frame: Assessed at 3-month follow-up. Count of participants. Unit: Participants

Measure	Control n = 29	Experimental n = 28
Value	2	4

Control vs Experimental: Risk Difference (RD): 0.08 (95% CI -0.08 to 0.24), p = 0.35, Regression, Linear

Population analysed: All individuals who installed the app (n = 57).

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: For each participant, adverse events (AE's) were collected over a 3 month period, starting at baseline and ending at 3-month follow-up. Events were monitored continually during this period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Experimental	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Limitations and caveats (from the sponsor): The purpose of this pilot was to inform feasibility and acceptability of the experimental app among smokers who were ambivalent about quitting. Data were analyzed among participants who installed the app (n = 57). This pilot study was not powered to provide definitive answers about the efficacy of the intervention in promoting smoking abstinence. A larger trial is needed for this.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37379059McClure JB, Heffner JL, Krakauer C, Mun S, Klasnja P, Catz SL. Feasibility, Acceptability, and Potential Impact of a Novel mHealth App for Smokers Ambivalent About Quitting: Randomized Pilot Study. JMIR Mhealth Uhealth. 2023 Jun 28;11:e46155. doi: 10.2196/46155.
Individual participant dataSharing planned: No. Data will not be shared.

Related trials for Tobacco Use Disorder

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer McClure, PhD principal investigator

Kaiser Permanente

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Experimental mHealth program and Nicotine patch in people with Tobacco Use Disorder and Smoking Cessation, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Program Engagement (time frame: Assessed at 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04560868, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.