- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01761760
Videogame-based Incentives for Smoking Cessation
Game-based Contingency Management for Smoking Cessation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Glassboro, New Jersey, United States, 08028
- Rowan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Contingent
Patients will earn game-based incentives contingent on meeting carbon monoxide goals. Behavioral: Videogame-based smoking cessation intervention |
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.
|
|
Active Comparator: Non-contingent
Patients will earn game-based incentives independent of meeting carbon monoxide goals. Behavioral: Videogame-based smoking cessation intervention |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sustained smoking abstinence
Time Frame: 7 weeks
|
Sustained abstinence will be collected via self-report
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reports of smoking status, videogame activity, physical and mental health
Time Frame: 7 weeks
|
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).
|
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
|
Carbon monoxide will be collected using a carbon monoxide monitor and submitted via.
throughout the study to verify smoking abstinence.
|
7 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bethany Raiff, Rowan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5R34DA033536-03 (U.S. NIH Grant/Contract)
- R34DA033536 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
National University of SingaporeRecruitingSmoking &Amp; Tobacco CessationSingapore
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedSmoking &Amp; Tobacco CessationUnited States
-
Sultan Qaboos UniversityCompletedSmoking Cessation | Tobacco Use Cessation | Smoking PreventionOman
-
The University of Hong KongCompletedSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong
Clinical Trials on Videogame-based smoking cessation intervention
-
National Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Changhai HospitalCompletedPancreatitis, ChronicChina
-
University of UtahPatient-Centered Outcomes Research InstituteActive, not recruitingTobacco Use | Tobacco Smoking | Current SmokerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCurrent Every Day Smoker | Cigarette SmokerUnited States
-
Huazhong University of Science and TechnologyEnrolling by invitation
-
Georgetown UniversityAlbert Einstein College of Medicine; University of MichiganCompletedTobacco Cessation | Tobacco Use Disorder | Tobacco Use Cessation | Tobacco Dependence | Virus, Human Immunodeficiency | Tobacco-Use DisorderUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedCigarette Smoking-Related CarcinomaUnited States
-
University of RochesterNational Cancer Institute (NCI); National Library of Medicine (NLM)Completed
-
University of VirginiaCompleted
-
University of SalernoNot yet recruitingSmoking Cessation | Smoking Behaviors | Smoking Dependence | Smoking Abstinence | Smoking Cessation Intervention | Smoking (Tobacco) Addiction | Smoking E-cigarette | Smoking Addiction | Smoking ( Cigarette)