Nicotine DependenceNCT05897242

A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults

A study testing Smartphone app, Text Message and Survey Administration in people with Nicotine Dependence and Nicotine Addiction, run by Fred Hutchinson Cancer Center 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

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Nicotine Dependence, Nicotine Addiction, Nicotine Use Disorder
What is being tested?: Smartphone app, Text Message and Survey Administration
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: 4 Jan 2024to 26 Apr 2024
Phase: Interventional
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 to 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 18-30.
Current weekly user of e-cigarette product(s).
Owns an Android phone or iPhone.
Has an email address.
United States (US) resident, with a US mailing address.
Willing to complete all study procedures.

Who cannot join

Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatments is allowable during trial participation).
Member of the same household as another research participant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109

Other trials in United States

About this study

Official title: ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation

Almost one in ten young adults report current e-cigarette use, putting them at risk of developing nicotine addiction and long-term health effects of exposure to inhaled toxicants. Despite the need for effective treatments to help these young users quit, very few treatments targeting any type of tobacco use among young adults have been evaluated, particularly for young adults who vape and have unique treatment needs. To address these needs, this trial will evaluate a digital program for young adult e-cigarette users at all stages of readiness to quit called ACT on Vaping.

Read the detailed description

OUTLINE:

Participants are randomized to 1 of 2 arms.

ARM I: Participants use the ACT on Vaping smartphone app and text messaging program and receive incentivized text messages assessing their vaping status.

ARM II: Participants receive incentivized text messages check-ins assessing their vaping status.

Conditions: Nicotine Dependence, Nicotine Addiction, Nicotine Use Disorder, Nicotine Vaping, Vaping
Being tested: Smartphone app, Text Message, Survey Administration
Medical subject headings: Tobacco Use Disorder, Vaping

What participants receive

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

Smartphone appBehavioural
Also called ACT on Vaping
Use ACT on Vaping smartphone app
Text MessageOther
Also called SMS Text
Receive text messages
Survey AdministrationOther
Ancillary studies

Study groups in NCT05897242
Study group	Role	What they receive
Arm I (Act on Vaping app)	Experimental	Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status. Receives: Behavioral: Smartphone app; Other: Text Message; Other: Survey Administration
Arm II (Incentivized text message check-ins)	Active comparator	Participants receive incentivized text messages check-ins assessing their vaping status. Receives: Other: Text Message; Other: Survey Administration

What is being measured

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

Overall Treatment Satisfaction Rating
We calculated descriptive statistics (mean, standard deviation) for the primary acceptability benchmark of overall satisfaction averaging at least 3.5 on a 1-5 Likert-type scale within the ACT on Vaping arm only.
Overall satisfaction was assessed with a 5-point Likert-type item on the 3-month follow-up survey, with response options ranging from (1) "not at all" to (5) "very much." The ACT on Vaping benchmark average of 3.5 falls between ratings of 3="somewhat" and 4="mostly." Higher values are associated with a higher level of satisfaction.
Measured: At 3 months post-randomization
Change in Readiness to Quit
Will evaluate differences of Contemplation Ladder scores. The 1-item Contemplation Ladder, scores range from 0-10, was used to assess readiness to quit using e-cigarettes. The higher the score, the more ready the person is to make a change. The anchor for the cut-off score of 5, indicating high vs. low quit readiness, is "Think I should quit but not quite ready."
Measured: From baseline to 3 months post-randomization
Percentage of Participants With a 24-hour Quit Attempt
Making a 24-hour quit attempt between baseline and 3-month follow-up was assessed via self-report at the 3-month follow-up survey. The percentage of participants with self-reported 24-hour quit attempts is evaluated descriptively.
Measured: At 3 months post-randomization
Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco
Complete case, self-reported 30-day abstinence from all nicotine and tobacco products at 3 months, confirmed via saliva cotinine testing. Differences were evaluated descriptively.
Measured: At 3 months post-randomization

Timeline

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

4 Jan 202426 Apr 2024

First posted9 Jun 2023
Study start4 Jan 2024
Primary completion26 Apr 2024
Study completion26 Apr 2024

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 Nicotine DependenceStudies of the same condition, open and under way.
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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05897242
Sponsor's protocol ID: RG1122763
Other IDs: NCI-2022-10010, UG3DA057032
Status last verified: Jun 2025
First submitted: 31 May 2023
Last updated: 24 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Heffner JL, Baker K, Georgiou K, Graham AL, Kelly MM, Konstantinou P, Lamprou E, Lele C, Lok KZ, Orzechowski M, Ruiz RA, Serfozo E, Karekla M. ACT on Vaping: Pilot Randomized Controlled Trial of a Novel Digital Health App With Text Messaging for Young Adult Vaping Cessation. Nicotine Tob Res. 2026 Apr 22;28(5):720-730. doi: 10.1093/ntr/ntaf112.
PubMed 40411791

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

Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking
Recruiting
Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke
Smoking Cessation, Depression
Not yet recruitingPhase 2
Effects of Psilocybin on Craving in Nicotine Dependence
Nicotine Dependence

All Nicotine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation
ClinicalTrials.gov ID: NCT05897242
Acronym / sponsor ID: RG1122763
Conditions: Nicotine Dependence, Nicotine Addiction, Nicotine Use Disorder, Nicotine Vaping, Vaping
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Fred Hutchinson Cancer CenterUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 4 Jan 2024 (actual)
Primary completion: 26 Apr 2024 (actual)
Study completion: 26 Apr 2024 (actual)
First posted: 9 Jun 2023 (actual)
Results: Posted 6 Jun 2025

Clinical summary

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

Detailed description

OUTLINE:

Participants are randomized to 1 of 2 arms.

ARM I: Participants use the ACT on Vaping smartphone app and text messaging program and receive incentivized text messages assessing their vaping status.

ARM II: Participants receive incentivized text messages check-ins assessing their vaping status.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm I (Act on Vaping app)	Experimental	Behavioral: Smartphone app, Other: Text Message, Other: Survey AdministrationParticipants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.
Arm II (Incentivized text message check-ins)	Active comparator	Other: Text Message, Other: Survey AdministrationParticipants receive incentivized text messages check-ins assessing their vaping status.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Age 18-30.
Current weekly user of e-cigarette product(s).
Owns an Android phone or iPhone.
Has an email address.
United States (US) resident, with a US mailing address.

Key exclusion criteria (2 listed)

Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatments is allowable during trial participation).
Member of the same household as another research participant.

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
Smartphone appAlso: ACT on VapingUse ACT on Vaping smartphone app	Behavioural	Arm I (Act on Vaping app)
Text MessageAlso: SMS TextReceive text messages	Other	Arm I (Act on Vaping app), Arm II (Incentivized text message check-ins)
Survey AdministrationAncillary studies	Other	Arm I (Act on Vaping app), Arm II (Incentivized text message check-ins)

Primary outcome

Overall Treatment Satisfaction Rating
Time frame: At 3 months post-randomization
We calculated descriptive statistics (mean, standard deviation) for the primary acceptability benchmark of overall satisfaction averaging at least 3.5 on a 1-5 Likert-type scale within the ACT on Vaping arm only. Overall satisfaction was assessed with a 5-point Likert-type item on the 3-month follow-up survey, with response options ranging from (1) "not at all" to (5) "very much." The ACT on Vaping benchmark average of 3.5 falls between ratings of 3="somewhat" and 4="mostly." Higher values are associated with a higher level of satisfaction.
Change in Readiness to Quit
Time frame: From baseline to 3 months post-randomization
Will evaluate differences of Contemplation Ladder scores. The 1-item Contemplation Ladder, scores range from 0-10, was used to assess readiness to quit using e-cigarettes. The higher the score, the more ready the person is to make a change. The anchor for the cut-off score of 5, indicating high vs. low quit readiness, is "Think I should quit but not quite ready."
Percentage of Participants With a 24-hour Quit Attempt
Time frame: At 3 months post-randomization
Making a 24-hour quit attempt between baseline and 3-month follow-up was assessed via self-report at the 3-month follow-up survey. The percentage of participants with self-reported 24-hour quit attempts is evaluated descriptively.
Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco
Time frame: At 3 months post-randomization
Complete case, self-reported 30-day abstinence from all nicotine and tobacco products at 3 months, confirmed via saliva cotinine testing. Differences were evaluated descriptively.

Results and safety

Results posted to the registry on 6 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I (Act on Vaping App)	31	23
Arm II (Incentivized Text Message Check-ins)	30	29

Primary outcome: Overall Treatment Satisfaction Rating

Time frame: At 3 months post-randomization. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm I (Act on Vaping App) n = 21
Value	3.8 (1.3)

Population analysed: We calculated descriptive statistics (e.g., means, proportions) for the ACT on Vaping treatment group to evaluate the go/no-go criteria and to compare the two arms on other indicators of treatment acceptability and efficacy. Given that pilot and feasibility trials are not appropriate designs for testing hypotheses regarding the efficacy of interventions, we focused on descriptive differences as an alternative to hypothesis testing.

Primary outcome: Change in Readiness to Quit

Time frame: From baseline to 3 months post-randomization. Mean (Standard Deviation). Unit: units on a scale

Measure	Arm I (Act on Vaping App) n = 24	Arm II (Incentivized Text Message Check-ins) n = 29
Value	0.96 (2.0)	0.72 (1.7)

Primary outcome: Percentage of Participants With a 24-hour Quit Attempt

Time frame: At 3 months post-randomization. Count of participants. Unit: Participants

Measure	Arm I (Act on Vaping App) n = 24	Arm II (Incentivized Text Message Check-ins) n = 29
Value	21	22

Primary outcome: Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco

Time frame: At 3 months post-randomization. Count of participants. Unit: Participants

Measure	Arm I (Act on Vaping App) n = 24	Arm II (Incentivized Text Message Check-ins) n = 29
Value	1	0

Adverse events

Time frame: Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I (Act on Vaping App)	0 of 31 (0%)	1 of 31 (3.2%)	0 of 31
Arm II (Incentivized Text Message Check-ins)	0 of 30 (0%)	3 of 30 (10%)	0 of 30

Limitations and caveats (from the sponsor): A limitation of this study is the small sample size, which, while appropriate for a pilot study, does not allow for a definitive evaluation of acceptability or efficacy and limits the generalizability of the findings. Additionally, the cotinine testing for biochemical verification of abstinence was not directly observed, leaving open the possibility that the test could have been completed by someone other than the participant.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40411791Heffner JL, Baker K, Georgiou K, Graham AL, Kelly MM, Konstantinou P, Lamprou E, Lele C, Lok KZ, Orzechowski M, Ruiz RA, Serfozo E, Karekla M. ACT on Vaping: Pilot Randomized Controlled Trial of a Novel Digital Health App With Text Messaging for Young Adult Vaping Cessation. Nicotine Tob Res. 2026 Apr 22;28(5):720-730. doi: 10.1093/ntr/ntaf112.
Individual participant dataSharing planned: No

Related trials for Nicotine Dependence

Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking
Recruiting
Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke
Smoking Cessation, Depression
Not yet recruitingPhase 2
Effects of Psilocybin on Craving in Nicotine Dependence
Nicotine Dependence

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.

Jaimee Heffner principal investigator

Fred Hutch/University of Washington Cancer Consortium

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

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone app, Text Message and Survey Administration in people with Nicotine Dependence and Nicotine Addiction, run by Fred Hutchinson Cancer Center 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 6 inclusion and 2 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 24 Jun 2025. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2025). 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?

Overall Treatment Satisfaction Rating (time frame: At 3 months post-randomization). The study lists 4 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 NCT05897242, 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 24 Jun 2025.