Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults

NCT05991882 | Recruiting

• 1 other identifier: R34DA056759
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Drinking; Cannabis Use

Outcome Measures

Primary Outcomes (3)

• Negative consequences associated with alcohol, marijuana, and simultaneous alcohol and marijuana (SAM) use

  Changes in negative consequences will be assessed using a measure that assesses alcohol, marijuana, and SAM use negative consequences. Items are rated dichotomously (yes/no).

  Through study completion, an average of 5 months

• Protective behavioral strategies for alcohol

  Changes in protective behavioral strategies for alcohol will be assessed using the Protective Drinking Practices Scale (PDPS), which assesses use of protective behavioral strategies related to alcohol on a 1 (never) to 6 (always) scale.

  Through study completion, an average of 5 months

• Protective behavioral strategies for marijuana

  Changes in protective behavioral strategies for marijuana will be assessed using the Protective Behavioral Strategies for Marijuana (PBSM) Scale, which assesses use of protective behavioral strategies related to marijuana on a 1 (never) to 6 (always) scale.

  Through study completion, an average of 5 months

Secondary Outcomes (8)

• Feasibility - study attrition

  Through study completion, an average of 5 months

• Feasibility - response rate

  Week 7

• Feasibility - module completion rate

  Week 7

• Feasibility - acceptability of the intervention

  Week 7

• Feasibility - perceived helpfulness of intervention strategies

  Week 7

Study Arms (8)

Condition 1: Craving daily+PBS daily

EXPERIMENTAL

EMA + Introduction Module + Craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily

Behavioral: Condition 1: Craving daily+PBS daily

Condition 2: Craving daily+PBS trigger

EXPERIMENTAL

EMA + Introduction Module + Craving reduction messages delivered once daily and PBS trigger messages

Behavioral: Condition 2: Craving daily+PBS trigger

Condition 3: Craving trigger+PBS daily

EXPERIMENTAL

EMA + Introduction Module + Craving reduction trigger messages and PBS messages delivered once daily

Behavioral: Condition 3: Craving trigger+PBS daily

Condition 4: Craving trigger+PBS trigger

EXPERIMENTAL

EMA + Introduction Module + Craving reduction trigger and PBS trigger messages

Behavioral: Condition 4: Craving trigger+PBS trigger

Condition 5: PBS daily+ PBS trigger

EXPERIMENTAL

EMA + Introduction Module + PBS delivered once daily and PBS trigger messages

Behavioral: Condition 5: PBS daily+ PBS trigger

Condition 6: Craving daily+Craving trigger

EXPERIMENTAL

EMA + Introduction Module + Craving reduction delivered once daily and craving reduction trigger messages

Behavioral: Condition 6: Craving daily+Craving trigger

Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger

EXPERIMENTAL

EMA + Introduction Module + Craving reduction delivered once daily, craving reduction trigger messages, PBS delivered once daily, and PBS trigger messages

Behavioral: Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger

Condition 8: No daily or trigger craving or PBS

OTHER

EMA + Introduction Module + no other messages

Behavioral: Condition 8: No daily or trigger craving or PBS

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 1: Craving daily+PBS daily

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 2: Craving daily+PBS trigger

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 3: Craving trigger+PBS 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 4: Craving trigger+PBS trigger

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 5: PBS daily+ PBS trigger

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 6: Craving daily+Craving trigger

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 7: Craving daily+Craving trigger+PBS daily+PBS trigger

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.

Condition 8: No daily or trigger craving or PBS

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• resident of state of Hawai'i and island of O'ahu
• age 18-30 years
• has sought services at Kaiser Permanente Hawaii within the past year
• report marijuana use, heavy drinking, and simultaneous alcohol and marijuana use
• report confidence in ability to use protective behavioral strategies
• endorse at least 3 recent negative consequences from marijuana and/or alcohol
• own a smartphone

You may not qualify if:

• any substance use treatment within the past 3 months

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Kaiser Permanente Hawaii, Center for Integrated Health Care Research

Honolulu, Hawaii, 96815, United States

RECRUITING

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Officials

• Kristina Phillips, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Phillips, PhD

CONTACT

808-432-4687; kristina.t.phillips@kp.org

Kara Tsuzaki, PharmD

CONTACT

808-432-5500; kara.k.tsuzaki@kp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the factorial trial will be informed generally of the assigned condition (i.e., introduction module + no daily messages or introduction module + daily messages), but not given detailed content.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of eight conditions

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: August 15, 2023
• Study Start: April 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

US (1)