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Behavioral Cues for Alcoholism
N/A
Waitlist Available
Led By Martin H Plawecki, MD, PhD
Research Sponsored by Indiana University
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 in two infusion sessions, to occur approximately 1-2 weeks apart
Awards & highlights
Study Summary
This trial will test if a laboratory model of human seeking despite aversion can be used as an early marker for disease onset and help identify effective treatments.
Who is the study for?
This trial is for right-handed individuals who can understand English, have a BMI between 18.5 and 32, and vary in their alcohol consumption history. It's not for those seeking substance abuse treatment, with positive drug or alcohol tests, on certain medications, with specific medical conditions, pregnant or breastfeeding women, or anyone actively suicidal within the last year.Check my eligibility
What is being tested?
The study examines how people seek alcohol even when faced with negative consequences. Participants will be exposed to aversive cues (unpleasant stimuli) and neutral cues while their reactions are observed to identify early signs of problematic drinking behavior.See study design
What are the potential side effects?
Since this trial involves psychological assessments rather than medication or invasive procedures, side effects may include discomfort from IV placement and potential distress from exposure to aversive cues during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ in two infusion sessions, to occur approximately 1-2 weeks apart
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in two infusion sessions, to occur approximately 1-2 weeks apart
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
IV alcohol self-administration
Trial Design
3Treatment groups
Experimental Treatment
Group I: Resting state connectivityExperimental Treatment2 Interventions
Some participants will also complete a functional magnetic resonance imaging (fMRI) session to determine resting state connectivity. All participants in this Arm will have completed both of the iv alcohol self-administration sessions (Aversive cue, Neutral cue).
Group II: Lower lifetime alcohol drinkingExperimental Treatment2 Interventions
Half of the participants will have a history of lower lifetime alcohol consumption; all will participate in both interventions (Aversive cue, Neutral cue).
Group III: Higher lifetime alcohol drinkingExperimental Treatment2 Interventions
Half of the participants will have a history of higher lifetime alcohol consumption; all will participate in both interventions (Aversive cue, Neutral cue).
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,855 Total Patients Enrolled
9 Trials studying Alcoholism
1,270 Patients Enrolled for Alcoholism
Purdue UniversityOTHER
224 Previous Clinical Trials
72,548 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
800 Previous Clinical Trials
1,362,781 Total Patients Enrolled
423 Trials studying Alcoholism
985,492 Patients Enrolled for Alcoholism
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are comfortable with having an IV placed.Your body mass index (BMI) falls between 18.5 and 32.I don't have any health issues that could impact the study's safety or results.You cannot participate if you are left-handed or can use both hands equally well (for the fMRI arm of the study only).You have a history of drinking too much or too little alcohol over your lifetime.You have had thoughts of hurting or killing yourself in the past year.You are pregnant or currently breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Resting state connectivity
- Group 2: Lower lifetime alcohol drinking
- Group 3: Higher lifetime alcohol drinking
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.
Does this research include testing on individuals over 35 years old?
"This research is open to anyone over the age of 21 and younger than 55."
Answered by AI
Are participants still being approved for this research project?
"That is correct. At the moment, the trial detailed on clinicaltrials.gov is looking for participants. The listing was first posted on April 1st, 2018 with the most recent update on March 28th, 2022. They are admitting a total of 100 patients at just 1 site."
Answered by AI
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