Inspired: Smartphone Videogame-Based Smoking Cessation Intervention

• ClinicalTrials.gov Identifier: NCT03929003
• Recruitment Status: Completed
• First Posted: April 26, 2019
• Last Update Posted: March 10, 2020
• Sponsor: Rowan University
• Information provided by (Responsible Party): Rowan University

Study Description

Brief Summary:

The investigators are testing a new, smartphone videogame-based intervention for smoking cessation.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Behavioral: Inspired	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two group randomization
• Masking: Single (Participant)
• Masking Description: Participants will not be told whether they are in the control or experimental group.
• Primary Purpose: Treatment
• Official Title: Breathe Free: Smartphone Videogame-Based Incentives for Smoking Cessation
• Actual Study Start Date: April 5, 2019
• Actual Primary Completion Date: January 1, 2020
• Actual Study Completion Date: January 20, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Contingent; Participants in this arm will be required to meet CO goals in order to earn game-based rewards.	Behavioral: Inspired; 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.
Active Comparator: Non-contingent; Participants in this arm will submit CO verifications but will earn game-based rewards independent of meeting CO goals.	Behavioral: Inspired; 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.

Outcome Measures

Primary Outcome Measures :

1. Smoking abstinence [ Time Frame: 7 days ]
   self-report of smoking abstinence over the previous 7-day period.

Secondary Outcome Measures :

1. Demographic [ Time Frame: 7 weeks ]
   description of participants

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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."

Contacts and Locations

Locations

United States, New Jersey

Rowan University

Glassboro, New Jersey, United States, 08028

Sponsors and Collaborators

Rowan University

More Information

• Responsible Party: Rowan University
• ClinicalTrials.gov Identifier: NCT03929003
• Other Study ID Numbers: ProG0520140170
• First Posted: April 26, 2019
• Last Update Posted: March 10, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No