Smoking CessationNCT03929003
Inspired: Smartphone Videogame-Based Smoking Cessation Intervention
A study testing Inspired in people with Smoking Cessation, run by Rowan University at 1 site in United States.
Trial summary
The investigators are testing a new, smartphone videogame-based intervention for smoking cessation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Inspired
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2019to 20 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusionary criteria: Participants will be required to be of legal smoking age (>19 in Alabama, Alaska, New Jersey, Utah, and in Onondaga, Nassau and Suffolk Counties in New York, > 18 years of age in the remainder of the United States). Participants must also report smoking >10 cigarettes per day, report smoking for >2 years, answer 8 or higher on a Likert scale asking how much the person wishes to quit smoking right now (1 = not at all, 10 =very much), have a smartphone with a data plan and active contract extending for at least two months from the enrollment date (i.e., the duration of the study), and reside in the U.S. Participants in the study must submit an initial CO reading > 10ppm (to prevent nonsmokers from enrolling in the study), Literacy will be assessed by having the participant read the first few lines of the consent form out loud, and will be an inclusion criterion because elements of "Breathe Free" will require reading.
Who cannot join
- Individuals will be excluded from the study if they report smoking any combustible products >2 times per month, report unstable medical/psychiatric conditions that might interfere with the study objectives (e.g., asthma), report living with someone who smokes in the house, or has a career that results in excessive exposure to CO. All excluded participants will be emailed the following smoking cessation information: the "Clearing the Air" packet developed by the National Cancer Institute, Smokefree.gov, Quitsmokinghelpline.com, and the National Academies Press "Dying to quit."
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breathe Free: Smartphone Videogame-Based Incentives for Smoking Cessation
The investigators are testing a new, smartphone videogame-based intervention for smoking cessation.
Read the detailed description
The investigators have developed a novel smartphone videogame, where smokers are required to submit breath carbon monoxide samples to demonstrate smoking abstinence, and where they will earn game-based rewards contingent on meeting CO goals. Players will be working with teams to earn group and social rewards to help advance their game.
- Conditions
- Smoking Cessation
- Being tested
- Inspired
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InspiredBehavioural
The investigators will be studying the ability of using videogame-based rewards to increase smoking abstinence when they are made contingent on meeting abstinence goals.
| Study group | Role | What they receive |
|---|---|---|
| Contingent | Experimental | Participants in this arm will be required to meet CO goals in order to earn game-based rewards. Receives: Behavioral: Inspired |
| Non-contingent | Active comparator | Participants in this arm will submit CO verifications but will earn game-based rewards independent of meeting CO goals. Receives: Behavioral: Inspired |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence
self-report of smoking abstinence over the previous 7-day period.
Measured: 7 days
Secondary outcomes (1)
Demographic
description of participants
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start5 Apr 2019
- Primary completion1 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929003
- Sponsor's protocol ID
- ProG0520140170
- Status last verified
- Mar 2020
- First submitted
- 26 Sep 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goodwin S, Nastasi JA, Newman ST, Rapoza D, Raiff BR. Feasibility and Acceptability of a Mobile Game to Support Smoking Cessation: Repeated Measures Study. JMIR Serious Games. 2024 Aug 21;12:e54684. doi: 10.2196/54684.
PubMed 39167443Upton CR, Nastasi JA, Raiff BR. Identifying Video Game Preferences Among Adults Interested in Quitting Smoking Cigarettes: Survey Study. JMIR Serious Games. 2022 Mar 24;10(1):e30949. doi: 10.2196/30949.
PubMed 35323116
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathe Free: Smartphone Videogame-Based Incentives for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03929003
- Acronym / sponsor ID
- ProG0520140170
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are testing a new, smartphone videogame-based intervention for smoking cessation.
Detailed description
The investigators have developed a novel smartphone videogame, where smokers are required to submit breath carbon monoxide samples to demonstrate smoking abstinence, and where they will earn game-based rewards contingent on meeting CO goals. Players will be working with teams to earn group and social rewards to help advance their game.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two group randomization
| Arm | Type | Receives |
|---|---|---|
| Contingent | Experimental | Behavioral: InspiredParticipants in this arm will be required to meet CO goals in order to earn game-based rewards. |
| Non-contingent | Active comparator | Behavioral: InspiredParticipants in this arm will submit CO verifications but will earn game-based rewards independent of meeting CO goals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusionary criteria: Participants will be required to be of legal smoking age (>19 in Alabama, Alaska, New Jersey, Utah, and in Onondaga, Nassau and Suffolk Counties in New York, > 18 years of age in the remainder of the United States). Participants must also report smoking >10 cigarettes per day, report smoking for >2 years, answer 8 or higher on a Likert scale asking how much the person wishes to quit smoking right now (1 = not at all, 10 =very much), have a smartphone with a data plan and active contract extending for at least two months from the enrollment date (i.e., the duration of the study), and reside in the U.S. Participants in the study must submit an initial CO reading > 10ppm (to prevent nonsmokers from enrolling in the study), Literacy will be assessed by having the participant read the first few lines of the consent form out loud, and will be an inclusion criterion because elements of "Breathe Free" will require reading.
Key exclusion criteria (1 listed)
- Individuals will be excluded from the study if they report smoking any combustible products >2 times per month, report unstable medical/psychiatric conditions that might interfere with the study objectives (e.g., asthma), report living with someone who smokes in the house, or has a career that results in excessive exposure to CO. All excluded participants will be emailed the following smoking cessation information: the "Clearing the Air" packet developed by the National Cancer Institute, Smokefree.gov, Quitsmokinghelpline.com, and the National Academies Press "Dying to quit."
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 |
|---|---|---|
| InspiredThe investigators will be studying the ability of using videogame-based rewards to increase smoking abstinence when they are made contingent on meeting abstinence goals. | Behavioural | Contingent, Non-contingent |
Primary outcome
Smoking abstinence
Time frame: 7 days
self-report of smoking abstinence over the previous 7-day period.
1 secondary outcome
Demographic
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 39167443Goodwin S, Nastasi JA, Newman ST, Rapoza D, Raiff BR. Feasibility and Acceptability of a Mobile Game to Support Smoking Cessation: Repeated Measures Study. JMIR Serious Games. 2024 Aug 21;12:e54684. doi: 10.2196/54684.
- Derived from this study: PubMed 35323116Upton CR, Nastasi JA, Raiff BR. Identifying Video Game Preferences Among Adults Interested in Quitting Smoking Cigarettes: Survey Study. JMIR Serious Games. 2022 Mar 24;10(1):e30949. doi: 10.2196/30949.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspired in people with Smoking Cessation, run by Rowan University 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 1 inclusion and 1 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 10 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Smoking abstinence (time frame: 7 days). 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 NCT03929003, which also lists 2 linked publications.
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 10 Mar 2020.