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Alcohol Use Disorder population completing Detoxification for Alcoholism (Mu Kappa Trial)

Phase < 1

Recruiting

Led By Kelly Cosgrove, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Healthy subjects will have no current or past diagnosis of AUD or other significant substance use disorder. They will drink less than 5 alcoholic drinks per week with no heavy drinking days (i.e., >4 drinks/day for men; >3 drinks/day for women) in the last 30 days;

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completed on second pkab/cfn imaging day (between 3 to 6 weeks into alcohol cessation)

Awards & highlights

Mu Kappa Trial Summary

This trial aims to use a type of brain imaging called positron emission tomography (PET) to measure certain receptors in the brains of individuals with alcohol use disorder (AUD). The goal is to understand

Who is the study for?

This trial is for adults with Alcohol Use Disorder (AUD) who drink heavily and are diagnosed according to DSM-5 criteria. Men must consume more than 14 drinks weekly, exceeding 4 per day twice a week; women over 7 weekly, exceeding 3 per day twice. Participants must be willing to try quitting alcohol and can read/write English.Check my eligibility

What is being tested?

The study uses PET brain imaging to measure Mu-Opioid and Kappa-Opioid receptors in people with AUD during a quit attempt. It aims to understand how these receptors relate to cravings, mood, withdrawal symptoms, and the time until they lapse back into drinking.See study design

What are the potential side effects?

While specific side effects aren't listed for this observational study using PET scans, common issues might include discomfort at the injection site for tracers used in imaging or temporary anxiety related to undergoing scans.

Mu Kappa Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I don't have a history of alcohol or significant substance abuse and drink less than 5 alcoholic drinks per week.

Mu Kappa Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between 3 to 6 weeks into alcohol cessation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between 3 to 6 weeks into alcohol cessation

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 3 to 6 weeks into alcohol cessation 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 Cue Reactivity Craving

Change in Alcohol Craving

Change in Alcohol Use

+4 more

Secondary outcome measures

Baseline Executive Function

Baseline Verbal Memory

Baseline Visual Attention

+10 more

Mu Kappa Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy Control populationExperimental Treatment2 Interventions

Subjects will be asked to complete both a 90 minute [11C]CFN and a 90 minute [11C]PKAB PET Imaging.

Group II: Alcohol Use Disorder population completing DetoxificationExperimental Treatment3 Interventions

Subjects will be asked to complete both 90 minute [11C]CFN and 90 minute [11C]PKAB PET Imaging after 1-3 days of a detoxification program.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

801 Previous Clinical Trials

1,365,185 Total Patients Enrolled

423 Trials studying Alcoholism

985,608 Patients Enrolled for Alcoholism

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,341 Total Patients Enrolled

84 Trials studying Alcoholism

10,279 Patients Enrolled for Alcoholism

Kelly Cosgrove, PhDPrincipal InvestigatorYale University

7 Previous Clinical Trials

336 Total Patients Enrolled

Frequently Asked Questions

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

What is the overall count of individuals actively participating in this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is actively seeking eligible participants. The trial was initially posted on November 1st, 2023 and recently updated on January 19th, 2024. In order to conduct the study, they aim to recruit a total of 100 individuals from a single designated location."

Answered by AI

Is the enrollment process currently ongoing for this research study?

"Indeed, the information available on clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking eligible patients. The study was initially posted for recruitment purposes on November 1st, 2023 and has since been updated as recently as January 19th, 2024. This particular study aims to enroll a total of 100 patients from a single location."

Answered by AI

Is the age limit for participation in this study restricted to individuals below 70 years old?

"This clinical trial is seeking individuals who are at least 21 years old but less than 70 years of age to participate."

Answered by AI

What are the anticipated results that this research aims to achieve?

"The primary focus of this trial is to evaluate Alcohol Cue Reactivity Craving within the first 3 to 6 weeks following alcohol cessation. Secondary objectives include assessing Visual Learning through a computerized task called One Card Learning Task, measuring Baseline Visual Processing Speed using Cogstate Detection Task, and evaluating Baseline Visual Learning with regards to correctly identified repeat cards in percentage (arcsine% correct)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating the Mu:Kappa Opioid Receptor Imbalance in Alcohol Use Disorder

Kelly Cosgrove 2023. "Investigating the Mu:Kappa Opioid Receptor Imbalance in Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05957159.