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Pilot Project 1. Feasibility Pilot of a JITAI to Reduce Cannabis Use Among Emerging Adults

Primary Purpose

Cannabis Use

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Just-In-Time-Adaptive-Intervention (JITAI)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cannabis Use focused on measuring Cannabis Use, Marijuana, Substance-Related Disorders, Mental Disorders

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    JITAI

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    App Feasibility
    % of participants who consented to the study who download the MiWaves app.
    App Acceptability
    Participants will complete acceptability ratings for the MiWaves app within their post-test assessment (percent with positive rating).

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2023
    Last Updated
    April 19, 2023
    Sponsor
    University of Michigan
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05824754
    Brief Title
    Pilot Project 1. Feasibility Pilot of a JITAI to Reduce Cannabis Use Among Emerging Adults
    Official Title
    Pilot Project 1. Feasibility Pilot of a JITAI to Reduce Cannabis Use Among Emerging Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan
    Collaborators
    National Institute on Drug Abuse (NIDA)

    4. Oversight

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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cannabis Use
    Keywords
    Cannabis Use, Marijuana, Substance-Related Disorders, Mental Disorders

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    JITAI
    Arm Type
    Experimental
    Arm Description
    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 Type
    Other
    Intervention Name(s)
    Just-In-Time-Adaptive-Intervention (JITAI)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    App Feasibility
    Description
    % of participants who consented to the study who download the MiWaves app.
    Time Frame
    1 month
    Title
    App Acceptability
    Description
    Participants will complete acceptability ratings for the MiWaves app within their post-test assessment (percent with positive rating).
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Inbal B Nahum-Shani, PhD
    Phone
    734-660-9626
    Email
    inbal@umich.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pilot Project 1. Feasibility Pilot of a JITAI to Reduce Cannabis Use Among Emerging Adults

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