Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
Kaiser Permanente
Study ID
NCT05991882
Status
Recruiting
Apply to this trial

Conditions

  • Alcohol Drinking
  • Cannabis Use

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Condition 1: Craving daily+PBS daily — BEHAVIORAL
    Participants in this condition will complete ecological momentary assessment (EMA) for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily, until the end of the six-week period.
  • Condition 2: Craving daily+PBS trigger — BEHAVIORAL
    Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages delivered once daily and PBS trigger messages that will be based on responses to signal-contingent EMA questions.
  • Condition 3: Craving trigger+PBS daily — BEHAVIORAL
    Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages that will be delivered based on responses to signal-contingent EMA questions and PBS delivered once daily.
  • Condition 4: Craving trigger+PBS trigger — BEHAVIORAL
    Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and PBS messages delivered based on responses to signal-contingent EMA questions.
  • Condition 5: PBS daily+ PBS trigger — BEHAVIORAL
    Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive PBS messages delivered once daily and PBS trigger messages that will be based on responses to signal-contingent EMA questions.
  • Condition 6: Craving daily+Craving trigger — BEHAVIORAL
    Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction messages delivered once daily and craving reduction trigger messages that will be based on responses to signal-contingent EMA questions.
  • Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger — BEHAVIORAL
    Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will then receive craving reduction and PBS messages delivered once daily and non-repetitive craving reduction and PBS trigger messages that will be based on responses to signal-contingent EMA questions.
  • Condition 8: No daily or trigger craving or PBS — BEHAVIORAL
    Participants in this condition will complete EMA for six weeks. Following the initial two weeks of EMA, participants in this condition will complete an introduction module including psychoeducation, personalized feedback, and goal setting. Participants will not receive any further intervention strategies.

Study Details

The goal of this treatment development project is to develop an adaptive ecological momentary intervention (a-EMI) for young adults using marijuana and alcohol that is grounded in self-regulation and social cognitive theories. To determine the most efficacious intervention strategies, the investigators will test variations of intervention components to identify the best combination. The study will take place at the Center for Integrated Health Care Research at Kaiser Permanente Hawaii (KPHI), located in Honolulu (island of Oahu). Following pilot testing with 6 participants, the study team will assess the feasibility and efficacy of intervention components on two primary outcomes (negative consequences and protective behavioral strategies \[PBS\]) using a fractional factorial experimental design, with post-intervention assessment and one- and three-month follow-ups. 136 diverse young adults recruited from KPHI who report current simultaneous alcohol and marijuana (SAM) use will be randomly assigned to one of eight groups, representing experimental conditions that include or do not include intervention strategies focused on craving reduction and PBS. As a result of this process, individual and/or combined components that lead to improved outcomes will be retained in a subsequent randomized controlled trial, while ineffective components will be eliminated.

Key Dates

Start date
Apr 1, 2024
Status verified
Mar 2025
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Condition 1: Craving daily+PBS daily
    EMA + Introduction Module + Craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily
  • Experimental: Condition 2: Craving daily+PBS trigger
    EMA + Introduction Module + Craving reduction messages delivered once daily and PBS trigger messages
  • Experimental: Condition 3: Craving trigger+PBS daily
    EMA + Introduction Module + Craving reduction trigger messages and PBS messages delivered once daily
  • Experimental: Condition 4: Craving trigger+PBS trigger
    EMA + Introduction Module + Craving reduction trigger and PBS trigger messages
  • Experimental: Condition 5: PBS daily+ PBS trigger
    EMA + Introduction Module + PBS delivered once daily and PBS trigger messages
  • Experimental: Condition 6: Craving daily+Craving trigger
    EMA + Introduction Module + Craving reduction delivered once daily and craving reduction trigger messages
  • Experimental: Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger
    EMA + Introduction Module + Craving reduction delivered once daily, craving reduction trigger messages, PBS delivered once daily, and PBS trigger messages
  • Other: Condition 8: No daily or trigger craving or PBS
    EMA + Introduction Module + no other messages

Primary Outcome Measure

Negative consequences associated with alcohol, marijuana, and simultaneous alcohol and marijuana (SAM) use [ Time Frame: Through study completion, an average of 5 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Hawaii, Center for Integrated Health Care ResearchHonoluluHawaii96815
Kara Tsuzaki, PharmD
[email protected]
808-272-5276
Kristina Phillips, PhD
[email protected]
808-432-4687
Kristina Phillips, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Kaiser Permanente Hawaii, Center for Integrated Health Care Research· Honolulu, HI

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