Smoking CessationNCT01761760
Videogame-based Incentives for Smoking Cessation
A study testing Videogame-based smoking cessation intervention in people with Smoking Cessation, run by Rowan University at 1 site in United States.
Trial summary
Investigators will be evaluating an online video-game-based smoking cessation intervention that will overcome barriers to treatment such as cost and sustainability. This videogame will be the first of its kind, based on an evidence-based intervention shown to promote smoking abstinence. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Videogame-based smoking cessation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2017to 30 Jul 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- smoking 10+ cigarettes per day
- smoking for 2+ years
- currently wishes to quit smoking
- has a computer at home with Internet access
- U.S. citizen
- literate
Who cannot join
- smoking other substances (e.g., marijuana, cigars) > 2 times per month
- unstable medical or psychiatric condition that might interfere with the program
- living with someone who smokes in the home
- a job that exposes the person to excessive ambient carbon monoxide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Game-based Contingency Management for Smoking Cessation
Investigators will be evaluating an online video-game-based smoking cessation intervention that will overcome barriers to treatment such as cost and sustainability. This videogame will be the first of its kind, based on an evidence-based intervention shown to promote smoking abstinence. The findings from this research will be of great public health significance because of the unprecedented reach and relatively low cost, as well as the potential for similar interventions to be developed for other health problems, such as alcohol or drug abuse and medication adherence for chronic illnesses
Read the detailed description
Cigarette smoking remains the number one cause of preventable morbidity and mortality in the U.S. A number of barriers have been noted that prevent access to smoking cessation interventions, such as lack of clinician training, the time commitment required to implement treatments, and the costs associated with treatment. Thus, it is critically important that more effective interventions be developed, and be made accessible at a relatively low cost, to smokers. We recently developed an Internet-based Contingency Management Intervention (CM),, where participants submit web-camera recorded videos as they exhale into a CO monitor, and they earn money for abstinence. Although the costs associated with providing monetary incentives contingent on smoking abstinence are likely to be less than the costs associated with medical complications caused by smoking, the cost of incentives is often cited as a barrier to CM. Thus, the goals of the present proposal are to markedly decrease costs and increase sustainability of this highly accessible Internet-based CM for smoking cessation.
Using an iterative development process with the help of a team of experts, a social strategy video game intended to be fun and engaging will be developed for Facebook ("Quitters, Incorporated"). Treatment-seeking smokers will be able to earn incentives contingent on meeting web-camera verified CO values consistent with smoking abstinence. Three powerful, evidence-based incentives will be harnessed in this CM. The incentives will consist of: (1) individual contingencies that can be used to improve game play, (2) social contingencies, such as positive feedback and virtual rewards, that can be given to other players to acknowledge their success with abstinence and improve their game play, and (3) group contingencies that will require all members of a group to meet abstinence goals in order to unlock access to certain game features. After game development, we will assess the feasibility, acceptability, enjoyability, and preliminary efficacy of video-game-based CM for smoking cessation. A 7-week pilot study will involve randomly assigning participants (N=100) to either: (1) abstinent contingent, where incentives will be delivered contingent on quitting smoking, or (2) submission contingent, where incentives will be delivered contingent on submitting videos, but independent of quitting smoking.
The outcomes of the pilot study will impact future research in the development of video-game-based CM interventions for smoking, as well as for alcohol and other drug use, and medication compliance in diabetes, asthma, and other conditions. Game-based CM will promote widespread access to this innovative, fun, sustainable intervention at a relatively low cost (the game will be available to play for free), thereby offering the potential to have a substantial public health impact.
- Conditions
- Smoking Cessation
- Being tested
- Videogame-based smoking cessation intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videogame-based smoking cessation interventionBehavioural
Patients will enroll in a videogame that is intended to help them quit smoking. They will be given goals for quitting (based on carbon monoxide readings submitted over a secure internet server) and will earn game-based incentives either contingent or noncontingent on meeting those goals.
| Study group | Role | What they receive |
|---|---|---|
| Contingent | Experimental | Patients will earn game-based incentives contingent on meeting carbon monoxide goals.
Behavioral: Videogame-based smoking cessation intervention Receives: Behavioral: Videogame-based smoking cessation intervention |
| Non-contingent | Active comparator | Patients will earn game-based incentives independent of meeting carbon monoxide goals.
Behavioral: Videogame-based smoking cessation intervention Receives: Behavioral: Videogame-based smoking cessation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained smoking abstinence
Sustained abstinence will be collected via self-report
Measured: 7 weeks
Secondary outcomes (2)
Self-reports of smoking status, videogame activity, physical and mental health
Patients will complete surveys on-line that ask questions regarding smoking status (how many cigarettes smoked per day), videogame activity (how much time is spent playing videogames), psychosocial health (e.g., physical health, mental health).
Measured: 7 weeks
Carbon monoxide in parts per million collected via a carbon monoxide monitor and submitted over a secure website via a web-camera recorded video.
Carbon monoxide will be collected using a carbon monoxide monitor and submitted via. throughout the study to verify smoking abstinence.
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 posted7 Jan 2013 (estimated)
- Study start8 May 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Why it stopped: There were a number of bugs in the game that meant the participants were not getting the intended intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Bethany Raiff, Rowan University
- Investigators
- Bethany Raiff, Principal investigator, Rowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761760
- Sponsor's protocol ID
- 5R34DA033536-03
- Other IDs
- R34DA033536
- Status last verified
- Apr 2019
- First submitted
- 21 Dec 2012
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Game-based Contingency Management for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01761760
- Acronym / sponsor ID
- 5R34DA033536-03
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There were a number of bugs in the game that meant the participants were not getting the intended intervention.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 7 Jan 2013 (estimated)
- 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.
Investigators will be evaluating an online video-game-based smoking cessation intervention that will overcome barriers to treatment such as cost and sustainability. This videogame will be the first of its kind, based on an evidence-based intervention shown to promote smoking abstinence. The findings from this research will be of great public health significance because of the unprecedented reach and relatively low cost, as well as the potential for similar interventions to be developed for other health problems, such as alcohol or drug abuse and medication adherence for chronic illnesses
Detailed description
Cigarette smoking remains the number one cause of preventable morbidity and mortality in the U.S. A number of barriers have been noted that prevent access to smoking cessation interventions, such as lack of clinician training, the time commitment required to implement treatments, and the costs associated with treatment. Thus, it is critically important that more effective interventions be developed, and be made accessible at a relatively low cost, to smokers. We recently developed an Internet-based Contingency Management Intervention (CM),, where participants submit web-camera recorded videos as they exhale into a CO monitor, and they earn money for abstinence. Although the costs associated with providing monetary incentives contingent on smoking abstinence are likely to be less than the costs associated with medical complications caused by smoking, the cost of incentives is often cited as a barrier to CM. Thus, the goals of the present proposal are to markedly decrease costs and increase sustainability of this highly accessible Internet-based CM for smoking cessation.
Using an iterative development process with the help of a team of experts, a social strategy video game intended to be fun and engaging will be developed for Facebook ("Quitters, Incorporated"). Treatment-seeking smokers will be able to earn incentives contingent on meeting web-camera verified CO values consistent with smoking abstinence. Three powerful, evidence-based incentives will be harnessed in this CM. The incentives will consist of: (1) individual contingencies that can be used to improve game play, (2) social contingencies, such as positive feedback and virtual rewards, that can be given to other players to acknowledge their success with abstinence and improve their game play, and (3) group contingencies that will require all members of a group to meet abstinence goals in order to unlock access to certain game features. After game development, we will assess the feasibility, acceptability, enjoyability, and preliminary efficacy of video-game-based CM for smoking cessation. A 7-week pilot study will involve randomly assigning participants (N=100) to either: (1) abstinent contingent, where incentives will be delivered contingent on quitting smoking, or (2) submission contingent, where incentives will be delivered contingent on submitting videos, but independent of quitting smoking.
The outcomes of the pilot study will impact future research in the development of video-game-based CM interventions for smoking, as well as for alcohol and other drug use, and medication compliance in diabetes, asthma, and other conditions. Game-based CM will promote widespread access to this innovative, fun, sustainable intervention at a relatively low cost (the game will be available to play for free), thereby offering the potential to have a substantial public health impact.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingent | Experimental | Behavioral: Videogame-based smoking cessation interventionPatients will earn game-based incentives contingent on meeting carbon monoxide goals. Behavioral: Videogame-based smoking cessation intervention |
| Non-contingent | Active comparator | Behavioral: Videogame-based smoking cessation interventionPatients will earn game-based incentives independent of meeting carbon monoxide goals. Behavioral: Videogame-based smoking cessation intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- smoking 10+ cigarettes per day
- smoking for 2+ years
- currently wishes to quit smoking
- has a computer at home with Internet access
Key exclusion criteria (4 listed)
- smoking other substances (e.g., marijuana, cigars) > 2 times per month
- unstable medical or psychiatric condition that might interfere with the program
- living with someone who smokes in the home
- a job that exposes the person to excessive ambient carbon monoxide
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 |
|---|---|---|
| Videogame-based smoking cessation interventionPatients will enroll in a videogame that is intended to help them quit smoking. They will be given goals for quitting (based on carbon monoxide readings submitted over a secure internet server) and will earn game-based incentives either contingent or noncontingent on meeting those goals. | Behavioural | Contingent, Non-contingent |
Primary outcome
Sustained smoking abstinence
Time frame: 7 weeks
Sustained abstinence will be collected via self-report
2 secondary outcomes
Self-reports of smoking status, videogame activity, physical and mental health
Time frame: 7 weeks
Carbon monoxide in parts per million collected via a carbon monoxide monitor and submitted over a secure website via a web-camera recorded video.
Time frame: 7 weeks
Results and safety
The study was stopped early (reason given: There were a number of bugs in the game that meant the participants were not getting the intended intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
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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.
Bethany Raiff principal investigator
Rowan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videogame-based smoking cessation intervention 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 26 Apr 2019. 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 was stopped early (reason given: There were a number of bugs in the game that meant the participants were not getting the intended intervention.). Results are not available in the source record.
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?
Sustained smoking abstinence (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2019.