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An App to Reduce Cannabis Use Among Emerging Adults

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ClinicalTrials.gov Identifier: NCT05824754
Recruitment Status : Recruiting
First Posted : April 24, 2023
Last Update Posted : March 7, 2024
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Inbal Billie Nahum-Shani, University of Michigan

Tracking Information
First Submitted Date  ICMJE April 6, 2023
First Posted Date  ICMJE April 24, 2023
Last Update Posted Date March 7, 2024
Actual Study Start Date  ICMJE February 21, 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2023)
  • App Feasibility [ Time Frame: 1 month ]
    % of participants who consented to the study who download the MiWaves app.
  • App Acceptability [ Time Frame: 1 month ]
    Participants will complete acceptability ratings for the MiWaves app within their post-test assessment (percent with positive rating).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An App to Reduce Cannabis Use Among Emerging Adults
Official Title  ICMJE Pilot Project 1. Feasibility Pilot of a JITAI to Reduce Cannabis Use Among Emerging Adults
Brief Summary This study is being completed to pilot prevention methods to promote wellness and reduce risky behaviors, including the use of substances such as cannabis. This study will help researchers learn about ways of delivering this information that is both appealing and helpful to young adults who use mobile apps.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cannabis Use
Intervention  ICMJE Other: Just-In-Time-Adaptive-Intervention (JITAI)

Behavioral: MiWaves behavioral messages

Participants will be using the MiWaves mobile app for 30 days. When a participant is assigned to receive a message, a message will be randomly selected from a pool of intervention message sets. Messages are based in motivational interviewing and include affect management and behavioral economic strategies.
Study Arms  ICMJE Experimental: JITAI

Experimental: Within-participant micro-randomization

Twice daily in the study, a participant is assigned to receive a message or no message. The micro-randomization will be performed by a reinforcement learning algorithm based on the participant's engagement with the intervention.

Intervention: Other: Just-In-Time-Adaptive-Intervention (JITAI)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2023)		 120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Reside in the US
  • Speak and read English
  • Have a smartphone on which the app can be downloaded
  • Screen positive for cannabis use 3 or more times each week over the past month
  • Report motivation to change cannabis as 1 or higher (using scale of 0-10)
  • Meet Study verification criteria (i.e., use of CAPTCHA, IP address checks)

Exclusion Criteria:

  • Use of Medical Cannabis
  • Failure to meet study verification criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Inbal B Nahum-Shani, PhD 734-660-9626 inbal@umich.edu
Contact: Lara Coughlin, PhD laraco@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05824754
Other Study ID Numbers  ICMJE HUM00222194
5P50DA054039-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
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
Plan to Share IPD: No
Current Responsible Party Inbal Billie Nahum-Shani, University of Michigan
Original Responsible Party Inbal Billie Nahum-Shani, University of Michigan, PhD
Current Study Sponsor  ICMJE University of Michigan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date March 2024

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