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Behavioural Intervention

Condition 7: Craving daily+Craving trigger+PBS daily+PBS trigger for Alcohol Consumption (SAFERR Trial)

N/A

Recruiting

Led By Kristina Phillips, PhD

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 5 months

Awards & highlights

SAFERR Trial Summary

This trial aims to develop an intervention for young adults who use marijuana and alcohol. The researchers will test different strategies to see which ones work best in reducing negative consequences and promoting protective behaviors. The study will

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this is a behavioral intervention involving mobile prompts rather than medication, traditional physical side effects are not expected. However, participants may experience psychological discomfort or stress due to self-monitoring or changes in behavior.

SAFERR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Protective behavioral strategies for alcohol

Protective behavioral strategies for marijuana

Secondary outcome measures

Feasibility - acceptability of the intervention

Feasibility - goal attainment

Feasibility - intervention engagement

+5 more

SAFERR Trial Design

8Treatment groups

Experimental Treatment

Group I: Condition 8: No daily or trigger craving or PBSExperimental Treatment1 Intervention

EMA + Introduction Module + no other messages

Group II: Condition 7: Craving daily+Craving trigger+PBS daily+PBS triggerExperimental Treatment1 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 triggerExperimental Treatment1 Intervention

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

Group IV: Condition 5: PBS daily+ PBS triggerExperimental Treatment1 Intervention

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

Group V: Condition 4: Craving trigger+PBS triggerExperimental Treatment1 Intervention

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

Group VI: Condition 3: Craving trigger+PBS dailyExperimental Treatment1 Intervention

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

Group VII: Condition 2: Craving daily+PBS triggerExperimental Treatment1 Intervention

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

Group VIII: Condition 1: Craving daily+PBS dailyExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

539 Previous Clinical Trials

24,113,276 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,595 Total Patients Enrolled

Kristina Phillips, PhDPrincipal InvestigatorKaiser Permanente Hawaii

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to enroll in this ongoing trial?

"According to the details on clinicaltrials.gov, this investigation is presently enrolling volunteers. The trial was first listed on April 1st, 2024 and underwent its latest revision on April 7th, 2024."

Answered by AI

What is the current number of individuals enrolled as participants in this medical study?

"Indeed, as per the details on clinicaltrials.gov, this current trial is actively seeking candidates. Originally shared on April 1st, 2024 and most recently revised on April 7th, 2024, the study aims to enroll a total of 136 participants from one designated site."

Answered by AI

Can individuals who have not reached the age of 70 participate in this medical study?

"Individuals aged over 18 years and under 30 years are eligible for participation in this study."

Answered by AI

Who is eligible to participate in this medical investigation?

"The trial aims to enroll 136 individuals aged between 18 and 30 who engage in alcohol consumption. Eligible participants must have utilized services at Kaiser Permanente Hawaii within the last year, disclosed marijuana use along with heavy drinking habits, reported concurrent usage of alcohol and marijuana, be residents of Hawai'i residing on O'ahu, expressed confidence in employing protective behavioral strategies, acknowledged experiencing a minimum of three adverse outcomes from recent alcohol or marijuana use, and possess a smartphone device."

Answered by AI

What is the primary aim of this investigation?

"Throughout the trial duration, set at an average of 5 months, the primary focus is on evaluating the adverse effects linked to alcohol consumption, marijuana use, and concurrent use of both substances. Secondary objectives include assessing response rates within a 6-week EMA framework, completion rates for educational modules with personalized feedback and goal setting components, as well as gauging participants' opinions on intervention strategies through a Feedback Measure tool."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults

2024. "Mobile Intervention for Simultaneous Alcohol and Marijuana Use in Young Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05991882.

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