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Brief Intervention for Alcohol Use Disorder

N/A
Recruiting
Research Sponsored by Western Kentucky University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 to 25
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month follow-up
Awards & highlights

Study Summary

This trialaims to improve a mobile intervention for young adults with heavy drinking & trauma, using coping strategies & peer coaches. Results will show if it reduces alcohol use & is perceived positively.

Who is the study for?
This trial is for young adults aged 18-25 who are college students, have a history of heavy alcohol use and interpersonal trauma. They must speak English, have access to a cell phone, and not be currently receiving therapy or medication for substance use.Check my eligibility
What is being tested?
The study tests a mobile-delivered brief intervention enhanced with coping strategies and peer support against a standard brief intervention and an assessment-only group. Participants will be randomly assigned to one of these groups and followed up at 3 and 6 months post-intervention.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, discussing trauma could potentially cause emotional discomfort or distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 25 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol use
Cannabis use
Cannabis-related problems
+3 more
Secondary outcome measures
Alcohol use motives
Coping self-efficacy
Marijuana use motives
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Trauma-Informed and Peer-Supported Brief Intervention (TIPS-BI)Experimental Treatment1 Intervention
In addition to the components of the standard brief intervention, the TIPS-BI will include personalized feedback about participants use of substances to cope. Additionally, participants will be provided with psychoeducation about the link between substance use, trauma, and coping motives, and information highlighting the iatrogenic effects that substance use has on negative emotions. Participants will also be given a series of evidence-based alternative coping strategies for managing trauma-related distress such as anxiety, depression, and PTSD. Participants will be asked to set goals related to utilization of these alternative coping strategies. Participants will then be informed that a trained peer who is part of the research team will follow up with them via text message at the monthly time points to review adherence to their goals and offer support.
Group II: Standard Brief InterventionExperimental Treatment1 Intervention
Immediately following completion of the baseline assessment, participants will be texted a link to a secure website which contains the participant's personalized feedback. Personalized feedback is automatically presented via a programming algorithm that is based on the participants baseline survey responses. The personalized feedback component will include a personalized substance use profile, information on peer norms, prior substance-related consequences experienced by the participant, practical costs (e.g., money spent on substances, fees for a DUI), and standard protective behavioral strategies to limit substance-related risk.
Group III: Assessment onlyExperimental Treatment1 Intervention
Following the baseline survey, participants in the assessment only group will be texted again 3 and 6 months later to complete follow up assessments. Following the end of the 6-month follow-up, participants will be offered an opportunity to complete the TIPS-BI without peer coach follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard Brief Intervention
2009
Completed Phase 3
~590
Assessment only
2014
N/A
~180

Find a Location

Who is running the clinical trial?

Western Kentucky UniversityLead Sponsor
11 Previous Clinical Trials
1,246 Total Patients Enrolled

Media Library

Standard Brief Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05414344 — N/A
Substance Abuse Research Study Groups: Trauma-Informed and Peer-Supported Brief Intervention (TIPS-BI), Standard Brief Intervention, Assessment only
Substance Abuse Clinical Trial 2023: Standard Brief Intervention Highlights & Side Effects. Trial Name: NCT05414344 — N/A
Standard Brief Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05414344 — N/A

Frequently Asked Questions

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

Is enrollment for this research study limited to those over 70 years of age?

"The lowest age of acceptance into this clinical trial is 18 years old, with the maximum being 25."

Answered by AI

Do I meet the criteria to join this research initiative?

"This clinical trial is seeking 165 participants aged 18-25 who have a history of alcohol consumption."

Answered by AI

Is enrollment for this research experiment currently open?

"This medical experiment, originally posted on September 29th 2022, is actively recruiting participants. Records hosted on clinicaltrials.gov confirm that it was last modified as recently as January 3rd 2023."

Answered by AI

What aims is this experiment hoping to accomplish?

"This research initiative seeks to study the change in Alcohol usage from baseline at 6-month follow up. Secondary measurements include The Brief Cope Inventory, Modified Drinking Motives Questionnaire - Revised, and The Substance Use Motives Measure which all measure different aspects of substance use motivation and coping mechanisms."

Answered by AI

How many people have enrolled in this experiment?

"Affirmative. The clinical trial's information hosted on the website clinicaltrials.gov attests to this study actively looking for individuals, initially posted September 29th 2022 and most recently updated January 3rd 2023. For now, 165 people are in search of enrollment at 1 site."

Answered by AI
~9 spots leftby May 2024