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

• Sponsor: University of Michigan (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05824754
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 120
• Arm: 1
• Anticipated Duration (Months): 11

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Use	Other: Just-In-Time-Adaptive-Intervention (JITAI)	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

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

Primary Outcome Measures

1. App Feasibility [1 month]

   % of participants who consented to the study who download the MiWaves app.

2. App Acceptability [1 month]

   Participants will complete acceptability ratings for the MiWaves app within their post-test assessment (percent with positive rating).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• University of Michigan
• National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Inbal Billie Nahum-Shani, PhD, University of Michigan
• ClinicalTrials.gov Identifier: NCT05824754
• Other Study ID Numbers: HUM00222194; 5P50DA054039-02
• First Posted: Apr 24, 2023
• Last Update Posted: Apr 24, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, PhD, University of Michigan: Cannabis Use; Marijuana; Substance-Related Disorders; Mental Disorders
• Additional relevant MeSH terms: Marijuana Abuse

Study Results

No Results Posted as of Apr 24, 2023