Mobile Intervention for Alcohol and Marijuana Use

(SAFERR Trial)

Overseen By Kara Tsuzaki, PharmD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Substance use treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help young adults manage alcohol and marijuana use. The app aims to identify the best strategies for reducing cravings and promoting protective behaviors to prevent negative outcomes. Participants will join different groups to determine which combination of strategies works best. Individuals living in Oahu who have used both substances together and experienced recent negative effects may be a good fit. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to effective strategies for managing substance use.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those who have received substance use treatment in the past 3 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using mobile apps to assist with alcohol and marijuana use is generally safe. In one study, participants using a phone-based app reported no serious side effects, indicating most handled it well. The goal is to use mobile technology to reduce the harmful effects of using alcohol and marijuana together.

While this specific app lacks approval, similar mobile tools have demonstrated safety. These apps help reduce cravings for alcohol and marijuana and promote safer behaviors. Participants receive messages on their phones to help manage cravings and make safer choices.

This trial is in the early stages, focusing on finding the best ways to help people. However, based on past studies of similar apps, the safety appears promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this mobile intervention for simultaneous alcohol and marijuana use because it offers a novel way to deliver support through daily and trigger-based messages. Unlike traditional treatments, which might include therapy sessions or medications, this approach leverages technology to deliver craving reduction and protective behavioral strategy (PBS) messages directly to participants' mobile devices. This method can offer timely support and potentially help users manage their cravings more effectively and immediately in real-world settings. By using this new delivery method, researchers hope to find out if technology can provide a more flexible and accessible support system for young adults dealing with substance use.

What evidence suggests that this trial's treatments could be effective for young adults using alcohol and marijuana?

Research has shown that using alcohol and marijuana simultaneously can lead to more negative effects than using either substance alone. In a study of over 1,000 young adults, about 20.7% reported using both substances together, which was linked to higher risks of binge drinking and negative outcomes. Previous programs aimed at young adults have successfully reduced cannabis use, even when compared to different groups. This trial will test various mobile intervention strategies to reduce cravings and encourage safer behaviors. Early results from similar methods suggest that well-timed messages can help manage cravings and promote safer habits. Participants in this trial will be assigned to different conditions, each involving a unique combination of craving reduction and protective behavioral strategy (PBS) messages. ^{1 3 4 6 7}

Who Is on the Research Team?

Kristina Phillips, PhD

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-30 in Hawaii who use marijuana and alcohol together, have experienced negative consequences from their use, and are confident they can follow protective strategies. They must have visited Kaiser Permanente Hawaii within the last year, live on O'ahu, and own a smartphone.

Inclusion Criteria

Resident of state of Hawai'i and island of O'ahu

Reports marijuana use, heavy drinking, and simultaneous alcohol and marijuana use

Owns a smartphone

Exclusion Criteria

History of any substance use treatment within the past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Testing

Pilot testing of the SAFERR a-EMI with 6 participants to assess feasibility and make necessary revisions

Not specified

Intervention

Participants complete a baseline assessment and are randomly assigned to one of eight conditions. They receive the SAFERR a-EMI intervention, including ecological momentary assessment (EMA) and introduction module

6 weeks

Signal-contingent and event-related EMA three times per day

Post-Intervention Assessment

Participants complete a post-intervention assessment to evaluate the efficacy of intervention components

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up assessments at one and three months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults

Trial Overview The study tests different mobile interventions to help manage cravings and encourage safe behaviors when using alcohol and marijuana. Participants will be placed into one of eight groups with varying combinations of daily or triggered intervention strategies related to craving control and protective behavior support.

How Is the Trial Designed?

Group I: Condition 8: No daily or trigger craving or PBS Experimental Treatment 1 Intervention

EMA + Introduction Module + no other messages

Group II: Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger Experimental Treatment 1 Intervention

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

Group III: Condition 6: Craving daily+Craving trigger Experimental Treatment 1 Intervention

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

Group IV: Condition 5: PBS daily+ PBS trigger Experimental Treatment 1 Intervention

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

Group V: Condition 4: Craving trigger+PBS trigger Experimental Treatment 1 Intervention

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

Group VI: Condition 3: Craving trigger+PBS daily Experimental Treatment 1 Intervention

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

Group VII: Condition 2: Craving daily+PBS trigger Experimental Treatment 1 Intervention

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

Group VIII: Condition 1: Craving daily+PBS daily Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A study involving 36 heavy-drinking young adults revealed that simultaneous use of alcohol and cannabis is influenced by specific physical, social, and situational factors, such as being in familiar and safe locations and being around approving peers.

Young adults are less likely to engage in simultaneous use in public spaces or when with family, indicating that their choices are heavily context-dependent, which could inform future prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights into the context of simultaneous alcohol and cannabis use among young adults. Boyle, HK., Singh, S., López, G., et al.[2023]

Among 148 young adults studied, those under 21 were more likely to use alcohol and marijuana simultaneously (SAM) when at home, while those 21 and older showed increased SAM use at friends' houses and outdoors, but lower odds at bars or clubs.

Despite the higher negative consequences associated with SAM use, the study found that it does not occur more frequently in high-risk environments, suggesting that interventions could focus on specific social contexts to address SAM use effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The socio-environmental context of simultaneous alcohol and marijuana use among young adults: Examining day-level associations. Linden-Carmichael, AN., Allen, HK., Lanza, ST.[2022]

Simultaneous alcohol and marijuana (SAM) use is prevalent among young adults, especially among those who consume these substances in larger quantities and more frequently, indicating a need for targeted interventions.

The review highlighted that SAM use is linked to both positive and negative consequences, and there are inconsistencies in how SAM use is measured and reported across studies, suggesting that future research should focus on the unique risks associated with SAM compared to using each substance separately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous Alcohol and Marijuana Use Among Young Adults: A Scoping Review of Prevalence, Patterns, Psychosocial Correlates, and Consequences. Lee, CM., Calhoun, BH., Abdallah, DA., et al.[2023]

In a study of 1,023 young adults, 20.7% reported simultaneous alcohol and marijuana use (SAM), which is linked to higher risks of binge drinking and impaired functioning compared to using either substance alone.

Beliefs about marijuana use and perceptions of parental approval for heavy drinking were significant risk factors for SAM, suggesting that addressing these attitudes could be key in prevention programs aimed at reducing risky substance use behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous use of marijuana and alcohol: Potential prevention targets among young adults who use alcohol. Skinner, ML., Guttmannova, K., Oesterle, S., et al.[2023]

A study involving 37 adolescents aged 14 to 17 revealed that app-based interventions for cannabis cessation could be more effective if they include rewards, self-monitoring features, and peer support, which resonate with the daily experiences of young users.

Key elements for engagement in the app included privacy, customizable notifications, and familiar interfaces, suggesting that tailoring interventions to adolescent preferences may enhance treatment retention and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End User-Informed Mobile Health Intervention Development for Adolescent Cannabis Use Disorder: Qualitative Study. Bagot, K., Hodgdon, E., Sidhu, N., et al.[2020]

Young adults who engage in simultaneous alcohol and marijuana (SAM) use consume more alcohol compared to days when they only drink alcohol, indicating a higher risk of alcohol-related consequences.

On SAM days, users reported more positive outcomes from alcohol consumption, although the negative consequences associated with alcohol use were less pronounced, suggesting a complex interaction between alcohol and marijuana that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Daily Study Comparing Alcohol-Related Positive and Negative Consequences for Days With Only Alcohol Use Versus Days With Simultaneous Alcohol and Marijuana Use in a Community Sample of Young Adults. Lee, CM., Patrick, ME., Fleming, CB., et al.[2021]

Among drivers aged 16 and older who used alcohol and cannabis, 42% reported driving under the influence, with simultaneous use of both substances leading to significantly higher odds of driving under the influence of cannabis (2.88 times) and both substances (3.51 times).

Interestingly, simultaneous use was associated with lower odds of driving under the influence of alcohol alone, suggesting that those who use both may not perceive their alcohol impairment as significant, highlighting the need for targeted prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous Alcohol/Cannabis Use and Driving Under the Influence in the U.S. Gonçalves, PD., Gutkind, S., Segura, LE., et al.[2023]

Simultaneous alcohol and marijuana (SAM) users experienced significantly more negative consequences compared to those who used alcohol and marijuana concurrently (CAM) or those who used only alcohol, even after accounting for usage frequency and other factors, with the most severe consequences being driving under the influence (DUI), blackouts, and cognitive issues.

Among SAM users, the negative consequences were primarily attributed to alcohol rather than the simultaneous use of both substances, indicating that both the type of user and the type of use are important factors in understanding the risks associated with substance use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consequences of alcohol and marijuana use among college students: Prevalence rates and attributions to substance-specific versus simultaneous use. Jackson, KM., Sokolovsky, AW., Gunn, RL., et al.[2021]

In a study of 87 community members, those who co-used alcohol and cannabis reported significantly higher scores on the Cannabis Use Disorder Identification Test (CUDIT), indicating a greater risk of cannabis dependence compared to non-co-users.

The pattern of using alcohol first and cannabis last (AFCL) was more prevalent among females and was associated with higher CUDIT scores and negative consequences, suggesting that the order of substance use can impact the risk of dependence and adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol First, Cannabis Last: Identification of an Especially Risky Use Pattern among Individuals Who Co-Use Alcohol and Cannabis. Karoly, HC., Prince, MA., Conner, BT.[2023]

The combined use of alcohol and cannabis is linked to unique characteristics and risks that differ from using either substance alone, highlighting the need for targeted prevention and intervention strategies.

This special issue includes 14 studies employing various methodologies, such as daily diary assessments and neuroimaging, to explore the patterns, motivations, and psychological processes behind alcohol and cannabis co-use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined use of alcohol and cannabis: Introduction to the special issue. Linden-Carmichael, AN., Wardell, JD.[2022]

In a study of 2,221 young adults in the Czech Republic, a significant correlation was found between alcohol consumption and marijuana use, with 21.8% reporting marijuana use in the past year.

Heavy episodic drinking and harmful drinking were strongly associated with higher rates of marijuana use, suggesting that interventions should address both alcohol and cannabis use together to effectively reduce substance-related problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol consumption and marijuana use in young adult Czechs. Csémy, L., Sovinová, H., Procházka, B.[2021]

In a study of 465,090 U.S. individuals aged 12 to 25, less frequent cannabis use (1-20 days/month) was significantly linked to higher rates of alcohol dependence and various alcohol-related problems, indicating that even occasional cannabis users may be at risk for alcohol use disorders.

The research suggests that both frequent and less frequent cannabis use are associated with serious alcohol-related issues, such as heavy drinking and risky behaviors, highlighting the need for careful consideration of cannabis use in alcohol treatment and policy planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of cannabis use and alcohol-associated adverse effects in a representative sample of U.S. adolescents and youth (2002-2014) a cross-sectional study. Ramadan, MM., Banta, JE., Bahjri, K., et al.[2021]

In a study of 8,626 adults, simultaneous use of cannabis and alcohol was found to be almost twice as common as concurrent use, indicating that many individuals tend to consume both substances at the same time.

Simultaneous use significantly increased the risks associated with alcohol, including doubling the odds of drunk driving, social consequences, and self-harm compared to those who only consumed alcohol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous versus concurrent use of alcohol and cannabis in the National Alcohol Survey. Subbaraman, MS., Kerr, WC.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05991882?cond=%22Marijuana%20Use%22&aggFilters=status:not%20rec&rank=7

Mobile Intervention for Simultaneous Alcohol and ... Recent research has shown that SAM use leads to greater negative consequences compared to use of either substance alone.

2. withpower.com withpower.com/trial/phase-alcohol-drinking-9-2023-b4118

Mobile Intervention for Alcohol and Marijuana Use In a study of 1,023 young adults, 20.7% reported simultaneous alcohol and marijuana use (SAM), which is linked to higher risks of binge drinking and impaired ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10530050/

Long-Term RCT outcomes for adolescent alcohol and ... Both interventions significantly reduced cannabis use, with no treatment group differences. When outcomes were examined comparing Hispanic to ...

4. researchprotocols.org researchprotocols.org/2024/1/e58685

Examining the Impact of Simultaneous Alcohol and ... This study was designed to examine naturalistic patterns of alcohol and cannabis use to understand how simultaneous use may impact drinking outcomes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10037905/

Study design to evaluate a web-intervention to prevent ... The current study proposes to evaluate the efficacy of webCHAT among 15.5 to 17-year-old adolescents (n = 150) recruited at driver education ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10810297/

A randomized pilot trial of a mobile phone–based brief ... The current study examined the efficacy of an accessible, low-cost, mobile phone–based brief intervention aimed at reducing DACU and RWCD among college cannabis ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547222001490

A randomized pilot trial of a mobile phone–based brief ... The intervention resulted in significant decreases in driving after cannabis use and riding with a cannabis-impaired driver. •. These findings provide initial ...