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Videogame-based Incentives for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01761760
Recruitment Status : Terminated (There were a number of bugs in the game that meant the participants were not getting the intended intervention.)
First Posted : January 7, 2013
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Bethany Raiff, Rowan University

Tracking Information
First Submitted Date  ICMJE December 21, 2012
First Posted Date  ICMJE January 7, 2013
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE May 8, 2017
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Sustained smoking abstinence [ Time Frame: 7 weeks ]
Sustained abstinence will be collected via self-report
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01761760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Videogame-based Incentives for Smoking Cessation
Official Title  ICMJE Game-based Contingency Management for Smoking Cessation
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Smoking Cessation
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Contingent

    Patients will earn game-based incentives contingent on meeting carbon monoxide goals.

    Behavioral: Videogame-based smoking cessation intervention

    Intervention: Behavioral: Videogame-based smoking cessation intervention
  • Active Comparator: Non-contingent

    Patients will earn game-based incentives independent of meeting carbon monoxide goals.

    Behavioral: Videogame-based smoking cessation intervention

    Intervention: Behavioral: Videogame-based smoking cessation intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 24, 2019)
24
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
100
Actual Study Completion Date  ICMJE July 30, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761760
Other Study ID Numbers  ICMJE 5R34DA033536-03( U.S. NIH Grant/Contract )
R34DA033536 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bethany Raiff, Rowan University
Study Sponsor  ICMJE Rowan University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Bethany Raiff Rowan University
PRS Account Rowan University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP