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An App to Reduce Cannabis Use Among Emerging Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cannabis Use Other: Just-In-Time-Adaptive-Intervention (JITAI) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Project 1. Feasibility Pilot of a JITAI to Reduce Cannabis Use Among Emerging Adults
Actual Study Start Date : February 21, 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
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.

 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.


Outcome Measures
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Primary Outcome Measures :
  1. App Feasibility [ Time Frame: 1 month ]
    % of participants who consented to the study who download the MiWaves app.

  2. App Acceptability [ Time Frame: 1 month ]
    Participants will complete acceptability ratings for the MiWaves app within their post-test assessment (percent with positive rating).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05824754


Contacts
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Contact: Inbal B Nahum-Shani, PhD 734-660-9626 inbal@umich.edu
Contact: Lara Coughlin, PhD laraco@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Lara Coughlin, PhD       laraco@med.umich.edu   
Sponsors and Collaborators
University of Michigan
National Institute on Drug Abuse (NIDA)
More Information
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Responsible Party: Inbal Billie Nahum-Shani, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT05824754    
Other Study ID Numbers: HUM00222194
5P50DA054039-02 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2023    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inbal Billie Nahum-Shani, University of Michigan:
Cannabis Use
Marijuana
Substance-Related Disorders
Mental Disorders
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders