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Feedback Interventions + Text Messages for Alcohol Use Disorder (MC2 Trial)
N/A
Waitlist Available
Led By Mary E Larimer, PhD
Research Sponsored by University of Washington
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 24 months of assessment
Awards & highlights
MC2 Trial Summary
This trial looks at whether it's better to present all parts of a medical intervention at once, or one at a time over several weeks.
Who is the study for?
This study is for individuals who have experienced negative consequences from alcohol use, as measured by specific tests, and engage in heavy drinking episodes. Participants must own a cell phone capable of receiving text messages and be willing to receive them. Those planning international travel soon or unwilling to consent are excluded.Check my eligibility
What is being tested?
The trial is testing two ways of delivering feedback on alcohol use: all at once (traditional) versus over several weeks (sequential). It also examines the effectiveness of follow-up text message boosters in influencing participants' behavior regarding alcohol consumption.See study design
What are the potential side effects?
Since this trial involves personalized feedback and text messaging interventions rather than medication, traditional side effects are not applicable. However, participants may experience discomfort or stress related to self-reflection on their alcohol use.
MC2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months of assessment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months of assessment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Alcohol Use at 12 months
Change from Baseline Alcohol Use at 18 months
Change from Baseline Alcohol Use at 24 months
+1 moreSecondary outcome measures
Alcohol Use during Birthday
Alcohol Use during Spring Break
Alcohol Use on 4th of July
+2 moreMC2 Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Simultaneous Post Feedback Information Delivery +Text MessagesExperimental Treatment2 Interventions
Participants receive all 4 feedback components immediately after providing consent to the Pilot Feasibility Study following the Screening/Baseline Survey. Participants complete a brief 10 minute Post-Feedback Survey and a 3 Week Followup Survey to assess knowledge of the intervention feedback content. Additionally, participants receive the Text Message Booster Component in the days before and during the high risk drinking event celebration(s).
Group II: Simultaneous Post Feedback Information DeliveryExperimental Treatment1 Intervention
Participants receive all 4 feedback components immediately after providing consent to the Pilot Feasibility Study following the Screening/Baseline Survey. Participants complete a brief 10 minute Post-Feedback Survey and a 3 Week Followup Survey to assess knowledge of the intervention feedback content.
Group III: Sequential Post Feedback Information Delivery +Text MessagesExperimental Treatment2 Interventions
Participants receive the first component of their PFI immediately following Baseline and subsequently receive 1 component each week until they receive all 4 components. Participants will complete a Post Feedback Survey and a 3 week follow back and Knowledge assessment. Additionally, participants receive the Text Message Booster Component in the days before and during the high risk drinking event celebration(s).
Group IV: Sequential Post Feedback Information DeliveryExperimental Treatment1 Intervention
Participants receive the first component of their PFI immediately following Baseline and subsequently receive 1 component each week until they receive all 4 components. Participants will complete a Post Feedback Survey and a 3 week follow back and Knowledge assessment.
Group V: Assessment Only ControlActive Control1 Intervention
Participants complete baseline survey, longitudinal follow up assessments, and pre- and post- event surveys.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Text Message Boosters
2018
N/A
~250
Find a Location
Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,364,385 Total Patients Enrolled
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,846,658 Total Patients Enrolled
Mary E Larimer, PhDPrincipal InvestigatorUniversity of Washington
3 Previous Clinical Trials
413 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have consumed a large amount of alcohol in a short period of time at least once in the past month.I am willing to participate in the clinical trial.
Research Study Groups:
This trial has the following groups:- Group 1: Simultaneous Post Feedback Information Delivery +Text Messages
- Group 2: Sequential Post Feedback Information Delivery
- Group 3: Sequential Post Feedback Information Delivery +Text Messages
- Group 4: Simultaneous Post Feedback Information Delivery
- Group 5: Assessment Only Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the principal aim of this experiment?
"This clinical trial, which will be monitored for a 6-month period, seeks to identify changes in alcohol use from baseline at 12 months. Additional objectives include the investigation of differences between groups regarding consumption on Halloween, Spring Break and New Year's Eve/Day."
Answered by AI
Does this research trial open its doors to individuals of advanced age?
"This clinical trial is recruiting adults who have not surpassed 24 years of age and are above the legal age of consent."
Answered by AI
Who is eligible to partake in this clinical research?
"For inclusion in this study, participants must display hazardous drinking behaviour and be between 18 and 24 years old. A total of 1012 people are sought for recruitment."
Answered by AI
Are there still vacancies for this trial available to participants?
"Clinicaltrials.gov indicates that the original posting of this medical trial on November 6th 2019 is not currently recruiting any more participants, however 11 other trials have opened up since then with open enrollment."
Answered by AI
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