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

Trial Summary

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.

What data supports the effectiveness of the treatment for simultaneous alcohol and marijuana use in young adults?

There is increasing evidence that mobile technology-based interventions can be effective for adults with substance use disorders, suggesting potential benefits for young adults using alcohol and marijuana together. ^{1 2 3 4 5}

Is the mobile intervention for alcohol and marijuana use safe for humans?

The studies reviewed focus on the risks and consequences of using alcohol and marijuana together, such as increased chances of driving under the influence and experiencing negative effects like blackouts and cognitive issues. However, they do not provide specific safety data on the mobile intervention itself. ^{6 7 8 9 10}

How is the Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults different from other treatments?

The Mobile Intervention for Simultaneous Alcohol and Marijuana Use is unique because it specifically targets the simultaneous use of both substances, which is associated with more negative consequences than using either substance alone. This approach may involve using mobile technology to provide real-time support and interventions, making it more accessible and tailored to the individual's daily life compared to traditional treatments. ^{5 7 11 12 13}

What is the purpose of this trial?

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.

Research Team

Kristina Phillips, PhD

Principal Investigator

Kaiser Permanente

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Simultaneous use of marijuana and alcohol: Potential prevention targets among young adults who use alcohol. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

End User-Informed Mobile Health Intervention Development for Adolescent Cannabis Use Disorder: Qualitative Study. [2020]

3. Czech Republic pubmed.ncbi.nlm.nih.gov

Alcohol consumption and marijuana use in young adult Czechs. [2021]

4. England 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. [2021]

5. Australia pubmed.ncbi.nlm.nih.gov

The socio-environmental context of simultaneous alcohol and marijuana use among young adults: Examining day-level associations. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Simultaneous versus concurrent use of alcohol and cannabis in the National Alcohol Survey. [2022]

7. England 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. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Simultaneous Alcohol/Cannabis Use and Driving Under the Influence in the U.S. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Alcohol First, Cannabis Last: Identification of an Especially Risky Use Pattern among Individuals Who Co-Use Alcohol and Cannabis. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Consequences of alcohol and marijuana use among college students: Prevalence rates and attributions to substance-specific versus simultaneous use. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Combined use of alcohol and cannabis: Introduction to the special issue. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Insights into the context of simultaneous alcohol and cannabis use among young adults. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Simultaneous Alcohol and Marijuana Use Among Young Adults: A Scoping Review of Prevalence, Patterns, Psychosocial Correlates, and Consequences. [2023]