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Attention Control Text Messaging for Alcohol Consumption (PASSION Trial)

N/A
Waitlist Available
Led By Dominic J Parrott, Ph.D.
Research Sponsored by Georgia State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Consumption of 4 (assigned female at birth) or 5 (assigned male at birth) alcoholic drinks on at least three days in the past year
Both partners must identify as cisgender and sexual minority or at least one partner must identify as a gender minority (i.e., one's gender identity is non-congruent with their sex assigned at birth)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up burst 2, daily for 14 days
Awards & highlights
No Placebo-Only Group

PASSION Trial Summary

This trial will study the effects of stress from the COVID-19 pandemic on heavy drinking and intimate partner violence in sexual and gender minority couples, and test a text messaging intervention to help mitigate these effects.

Eligible Conditions
  • Alcohol Consumption
  • Domestic Violence
  • Stress
  • Aggression

PASSION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have consumed a certain amount of alcohol on multiple occasions in the past year, depending on your gender assigned at birth.
Select...
One or both partners must identify as a sexual or gender minority.

PASSION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~burst 1, daily for 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and burst 1, daily for 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Drinking Episodes (Burst 1)
Drinking Episodes (Burst 2)
Drinking Episodes (Burst 3)
+5 more
Secondary outcome measures
COVID-19 Stress (Burst 1)
COVID-19 Stress (Burst 2)
COVID-19 Stress (Burst 3)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

PASSION Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: No Intervention, CBT Texts (AC)Experimental Treatment1 Intervention
Participants do not receive text messages during Interval 2. Participants receive CBT text messages during Interval 3.
Group II: CBT Texts, No Intervention (CA)Experimental Treatment1 Intervention
Participants receive CBT text messages during Interval 2. Participants do not receive text messages during Interval 3.
Group III: CBT Texts, Attention-Control Texts (CB)Experimental Treatment2 Interventions
Participants receive CBT text messages during Interval 2. Participants receive attention control text messages during Interval 3.
Group IV: Attention-Control Texts, CBT Texts (BC)Experimental Treatment2 Interventions
Participants receive attention control text messages during Interval 2. Participants receive CBT text messages during Interval 3.
Group V: No Intervention, No Intervention (AA)Active Control1 Intervention
Participants do not receive text messages during Interval 2 or Interval 3.
Group VI: Attention-Control Texts, No Intervention (BA)Active Control1 Intervention
Participants receive attention control text messages during Interval 2. Participants do not receive text messages during Interval 3.
Group VII: No Intervention, Attention-Control Texts (AB)Active Control1 Intervention
Participants do not receive text messages during Interval 2. Participants receive attention control text messages during Interval 3.
Group VIII: Attention-Control Texts, Attention-Control Texts (BB)Active Control1 Intervention
Participants receive attention control text messages during Interval 2. Participants receive attention control text messages during Interval 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Attention Control Text Messaging
2020
N/A
~480
CBT Text Messaging
2020
N/A
~480

Find a Location

Who is running the clinical trial?

University of LouisvilleOTHER
334 Previous Clinical Trials
75,539 Total Patients Enrolled
University at BuffaloOTHER
129 Previous Clinical Trials
96,373 Total Patients Enrolled
Georgia State UniversityLead Sponsor
56 Previous Clinical Trials
24,577 Total Patients Enrolled

Media Library

Attention Control Text Messaging Clinical Trial Eligibility Overview. Trial Name: NCT04625465 — N/A
Alcohol Consumption Research Study Groups: No Intervention, No Intervention (AA), No Intervention, CBT Texts (AC), CBT Texts, No Intervention (CA), Attention-Control Texts, No Intervention (BA), No Intervention, Attention-Control Texts (AB), Attention-Control Texts, Attention-Control Texts (BB), Attention-Control Texts, CBT Texts (BC), CBT Texts, Attention-Control Texts (CB)
Alcohol Consumption Clinical Trial 2023: Attention Control Text Messaging Highlights & Side Effects. Trial Name: NCT04625465 — N/A
Attention Control Text Messaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04625465 — N/A

Frequently Asked Questions

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

What is the ultimate purpose of this investigation?

"The principal aim of this experiment, which will be monitored for a fortnight, is to gauge the prevalence of Intimate Partner Violence Events (IPVE). Secondary objectives include assessing stress due to COVID-19 at different points in time and measuring discrimination related to one's sexual or gender identity."

Answered by AI

What is the uppermost participant count for this research endeavor?

"Yes, the clinicaltrials.gov website attests that this research is in need of participants and was first posted on November 12th 2020 with a recent update taking place March 15th 2022. This trial aims to accrue 480 individuals from its single site."

Answered by AI

Are there any vacancies in this clinical trial that are available to those seeking treatment?

"Clinicaltrials.gov reports that this clinical trial is open for enrolment and has been since November 12th 2020. The post was last updated on March 15th 2022."

Answered by AI
~113 spots leftby Feb 2025