Alcohol DrinkingSAFERRNCT05991882
Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults
A study testing Condition 1: Craving daily+PBS daily, Condition 2: Craving daily+PBS trigger and Condition 3: Craving trigger+PBS daily in people with Alcohol Drinking and Cannabis Use, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Alcohol Drinking, Cannabis Use
- What is being tested?
- Condition 1: Craving daily+PBS daily, Condition 2: Craving daily+PBS trigger and Condition 3: Craving trigger+PBS daily
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- any substance use treatment within the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Hawaii, Center for Integrated Health Care Research
Honolulu, Hawaii, 96815
About this study
Official title: Mobile Adaptive Intervention to Reduce Negative Consequences Associated With Simultaneous Alcohol and Marijuana Use in Young Adults in Primary Care
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.
Read the 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.
- Conditions
- Alcohol Drinking, Cannabis Use
- Being tested
- Condition 1: Craving daily+PBS daily, Condition 2: Craving daily+PBS trigger, Condition 3: Craving trigger+PBS daily, Condition 4: Craving trigger+PBS trigger, Condition 5: PBS daily+ PBS trigger
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Condition 1: Craving daily+PBS dailyBehavioural
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 triggerBehavioural
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 dailyBehavioural
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 triggerBehavioural
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 triggerBehavioural
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 triggerBehavioural
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 triggerBehavioural
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 PBSBehavioural
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 group | Role | What they receive |
|---|---|---|
| Condition 1: Craving daily+PBS daily | Experimental | EMA + Introduction Module + Craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily Receives: 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 Receives: 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 Receives: Behavioral: Condition 3: Craving trigger+PBS daily |
| Condition 4: Craving trigger+PBS trigger | Experimental | EMA + Introduction Module + Craving reduction trigger and PBS trigger messages Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Condition 8: No daily or trigger craving or PBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 5 months
Secondary outcomes (8)
Feasibility - study attrition
Number of completed study phases, including six weeks of ecological momentary assessment (EMA), the 4-week a-EMI period, post-intervention assessment, and one- and three-month follow-up assessments.
Measured: Through study completion, an average of 5 months
Feasibility - response rate
Number of completed prompts across 6-week EMA
Measured: Week 7
Feasibility - module completion rate
Completion of introduction module focused on psychoeducation, personalized feedback, and goal setting
Measured: Week 7
Feasibility - acceptability of the intervention
The revised Client Satisfaction Questionnaire (CSQ-8) will assess satisfaction with the intervention, perceptions of format and language of the a-EMI messages, and usability of the a-EMI (e.g., manner in which information was presented, language, question/intervention strategy comprehension, strategy delivery, timing, and study and a-EMI burden).
Measured: Week 7
Feasibility - perceived helpfulness of intervention strategies
A Feedback Measure will assess perceptions of the helpfulness of particular intervention strategies, as well as other useful strategies that could be added.
Measured: Week 7
Feasibility - intervention implementation
Intervention implementation will be examined through a short survey that will assess the ease of app use and accessibility, any challenges requesting strategies when needed, and any problems with the technology.
Measured: Week 7
Feasibility - intervention engagement
Intervention engagement will be assessed by examining participant's use of intervention strategies.
Measured: Week 7
Feasibility - goal attainment
Participants will be asked to report whether they attained or made progress on goals identified in the a-EMI introduction module.
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Apr 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Participants will be randomly assigned to one of eight conditions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kristina Phillips, PhD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991882
- Sponsor's protocol ID
- R34DA056759
- Other IDs
- R34DA056759
- Acronym
- SAFERR
- Status last verified
- Aug 2026
- First submitted
- 1 May 2023
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Adaptive Intervention to Reduce Negative Consequences Associated With Simultaneous Alcohol and Marijuana Use in Young Adults in Primary Care
- ClinicalTrials.gov ID
- NCT05991882
- Acronym / sponsor ID
- SAFERR / R34DA056759
- Conditions
- Alcohol Drinking, Cannabis Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- Participants will be randomly assigned to one of eight conditions
| Arm | Type | Receives |
|---|---|---|
| Condition 1: Craving daily+PBS daily | Experimental | Behavioral: Condition 1: Craving daily+PBS dailyEMA + Introduction Module + Craving reduction and protective behavioral strategy (PBS) messages, each delivered once daily |
| Condition 2: Craving daily+PBS trigger | Experimental | Behavioral: Condition 2: Craving daily+PBS triggerEMA + Introduction Module + Craving reduction messages delivered once daily and PBS trigger messages |
| Condition 3: Craving trigger+PBS daily | Experimental | Behavioral: Condition 3: Craving trigger+PBS dailyEMA + Introduction Module + Craving reduction trigger messages and PBS messages delivered once daily |
| Condition 4: Craving trigger+PBS trigger | Experimental | Behavioral: Condition 4: Craving trigger+PBS triggerEMA + Introduction Module + Craving reduction trigger and PBS trigger messages |
| Condition 5: PBS daily+ PBS trigger | Experimental | Behavioral: Condition 5: PBS daily+ PBS triggerEMA + Introduction Module + PBS delivered once daily and PBS trigger messages |
| Condition 6: Craving daily+Craving trigger | Experimental | Behavioral: Condition 6: Craving daily+Craving triggerEMA + Introduction Module + Craving reduction delivered once daily and craving reduction trigger messages |
| Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger | Experimental | Behavioral: Condition 7: Craving daily+Craving trigger+PBS daily+PBS triggerEMA + Introduction Module + Craving reduction delivered once daily, craving reduction trigger messages, PBS delivered once daily, and PBS trigger messages |
| Condition 8: No daily or trigger craving or PBS | Other | Behavioral: Condition 8: No daily or trigger craving or PBSEMA + Introduction Module + no other messages |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- any substance use treatment within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Condition 1: Craving daily+PBS dailyParticipants 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. | Behavioural | Condition 1: Craving daily+PBS daily |
| Condition 2: Craving daily+PBS triggerParticipants 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. | Behavioural | Condition 2: Craving daily+PBS trigger |
| Condition 3: Craving trigger+PBS dailyParticipants 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. | Behavioural | Condition 3: Craving trigger+PBS daily |
| Condition 4: Craving trigger+PBS triggerParticipants 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. | Behavioural | Condition 4: Craving trigger+PBS trigger |
| Condition 5: PBS daily+ PBS triggerParticipants 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. | Behavioural | Condition 5: PBS daily+ PBS trigger |
| Condition 6: Craving daily+Craving triggerParticipants 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. | Behavioural | Condition 6: Craving daily+Craving trigger |
| Condition 7: Craving daily+Craving trigger+PBS daily+PBS triggerParticipants 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. | Behavioural | Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger |
| Condition 8: No daily or trigger craving or PBSParticipants 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. | Behavioural | Condition 8: No daily or trigger craving or PBS |
Primary outcome
Negative consequences associated with alcohol, marijuana, and simultaneous alcohol and marijuana (SAM) use
Time frame: Through study completion, an average of 5 months
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).
Protective behavioral strategies for alcohol
Time frame: Through study completion, an average of 5 months
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.
Protective behavioral strategies for marijuana
Time frame: Through study completion, an average of 5 months
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.
8 secondary outcomes
Feasibility - study attrition
Time frame: Through study completion, an average of 5 months
Feasibility - response rate
Time frame: Week 7
Feasibility - module completion rate
Time frame: Week 7
Feasibility - acceptability of the intervention
Time frame: Week 7
Feasibility - perceived helpfulness of intervention strategies
Time frame: Week 7
Feasibility - intervention implementation
Time frame: Week 7
Feasibility - intervention engagement
Time frame: Week 7
Feasibility - goal attainment
Time frame: Through study completion, an average of 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Phillips, PhD principal investigator
University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Condition 1: Craving daily+PBS daily, Condition 2: Craving daily+PBS trigger and Condition 3: Craving trigger+PBS daily in people with Alcohol Drinking and Cannabis Use, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.