Clinical trial NCT05991882: Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults
Official title: Mobile Adaptive Intervention to Reduce Negative Consequences Associated With Simultaneous Alcohol and Marijuana Use in Young Adults in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Cannabis Use
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-08-15
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants will be randomly assigned to one of eight conditions
Primary purpose: TREATMENT

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.

Detailed description: Up to one-third of young adults report use of marijuana or alcohol in the past month, with sizable numbers reporting daily marijuana use and heavy episodic drinking. Simultaneous alcohol and marijuana (SAM) use, defined as use of both substances at the same time or within a few hours of each other with overlapping effects, is common among young adults. Recent research has shown that SAM use leads to greater negative consequences compared to use of either substance alone. No current intervention addresses SAM use specifically and few leverage new technological methods (e.g., smartphones) or strategies (e.g., protective behavioral strategies \[PBS\]) to engage young adults.

The goal of this Stage I treatment development project is to develop a fully mobile adaptive ecological momentary intervention (a-EMI) titled "Smartphone App For Effectively Reducing Risk (SAFERR)" 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. They will assess the feasibility and efficacy of intervention components on two outcomes (negative consequences and PBS) using a fractional factorial experimental design.

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, the SAFERR a-EMI will be administered to 6 eligible participants. Based on the feedback, the app will be revised and a trial of the SAFERR intervention will begin. 136 diverse young adults who report current SAM use will be recruited from primary care clinics at KPHI. Eligible individuals will complete a baseline assessment and then be randomly assigned (by sex) to one of eight conditions using stratified randomization. Each condition either includes or does not include four different intervention strategies focused on craving reduction and PBS. All participants will complete signal-contingent (random prompts three times per day) and event-related ecological momentary assessment (EMA) for 6 weeks using a smartphone application (app). EMA will continue during the 4-week intervention phase. At the beginning of the intervention, all participants will complete an introduction module via the study app that includes psychoeducation, personalized feedback, and goal setting. Participants will then begin the a-EMI via the study app, with components delivered based on their condition assignment.

Following completion of the intervention, participants will complete a post-intervention assessment and follow-up assessments at one- and three-months. The feasibility of the a-EMI and design will be examined by assessing: study attrition and response rates/time, module completion rates, acceptability (satisfaction, usability), perceived helpfulness, goal attainment, and implementation and intervention engagement. The efficacy of intervention components on negative consequences and PBS during EMA and at post-intervention and one-month and three-month follow-ups will be examined. In a future, larger study, the most useful components will be incorporated into a full intervention package and tested in a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

• any substance use treatment within the past 3 months

Primary outcomes:
measure: Negative consequences associated with alcohol, marijuana, and simultaneous alcohol and marijuana (SAM) use
timeFrame: Through study completion, an average of 5 months
measure: Protective behavioral strategies for alcohol
timeFrame: Through study completion, an average of 5 months
measure: Protective behavioral strategies for marijuana
timeFrame: Through study completion, an average of 5 months
Secondary outcomes:
measure: Feasibility - study attrition
timeFrame: Through study completion, an average of 5 months
measure: Feasibility - response rate
timeFrame: Week 7
measure: Feasibility - module completion rate
timeFrame: Week 7
measure: Feasibility - acceptability of the intervention
timeFrame: Week 7
measure: Feasibility - perceived helpfulness of intervention strategies
timeFrame: Week 7
measure: Feasibility - intervention implementation
timeFrame: Week 7
measure: Feasibility - intervention engagement
timeFrame: Week 7
measure: Feasibility - goal attainment
timeFrame: Through study completion, an average of 5 months
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii, Center for Integrated Health Care Research
state: Hawaii
Study officials:
affiliation: Kaiser Permanente
name: Kristina Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References: