RECRUITING

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

Conditions

Alcohol Use Disorder Alcohol Alcohol cessation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this multimodal positron emission tomography (PET) study is to use PET brain imaging to measure both MOR (Mu-Opioid receptors) and KOR (kappa-opioid receptors) in participants with alcohol use disorder (AUD) and to quantify the relationships between MOR and KOR, separately and jointly, to key clinical outcomes (e.g., craving, mood, withdrawal, time to lapse) during a quit attempt.

Official Title

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

Quick Facts

Study Start:2023-11-07

Study Completion:2028-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05957159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants with AUD will have a current diagnosis of AUD according to DSM-5 criteria (i.e., SCID-5 ascertained diagnosis, confirmed by the Principal Investigators); * Participants with AUD will meet the following drinking criteria: males will drink \> 14 drinks per week and exceed 4 drinks per day at least twice per week; females will drink \> 7 drinks per week and exceed 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period within the 90 days prior to intake; * Participants with AUD will indicate willingness to abstain from alcohol and engage in a quit attempt; * 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; * Able to read and write English and to provide voluntary, written informed consent; * Agree to have blood drawn for genotyping of the OPRM1 which has been shown to impact the \[11C\]CFN outcome measure, BPND50.	* Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology that would impact the integrity of the data (note that elevated liver enzymes for individuals with AUD will not be exclusionary); * Past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder; * Current significant psychiatric disorder including severe substance use disorder (other than alcohol or tobacco use disorders\), and past or current psychotic symptoms; Regular use in the past 6 months of any prescription, psychoactive or herbal medications (e.g., antidepressants, antipsychotics, anxiolytics) that would impact the integrity of the data (e.g., naltrexone); No subject will be asked to stop taking medication to participate in the study; * Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or her partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD; * Contraindications to MRI such as claustrophobia or metal in their body; * Subjects whose participation would cause them to exceed yearly radiation limits for research subjects

Inclusion Criteria

Exclusion Criteria

* Participants with AUD will have a current diagnosis of AUD according to DSM-5 criteria (i.e., SCID-5 ascertained diagnosis, confirmed by the Principal Investigators);
* Participants with AUD will meet the following drinking criteria: males will drink \> 14 drinks per week and exceed 4 drinks per day at least twice per week; females will drink \> 7 drinks per week and exceed 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period within the 90 days prior to intake;
* Participants with AUD will indicate willingness to abstain from alcohol and engage in a quit attempt;
* 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;
* Able to read and write English and to provide voluntary, written informed consent;
* Agree to have blood drawn for genotyping of the OPRM1 which has been shown to impact the \[11C\]CFN outcome measure, BPND50.

* Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology that would impact the integrity of the data (note that elevated liver enzymes for individuals with AUD will not be exclusionary);
* Past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder;
* Current significant psychiatric disorder including severe substance use disorder (other than alcohol or tobacco use disorders\*), and past or current psychotic symptoms;
* Regular use in the past 6 months of any prescription, psychoactive or herbal medications (e.g., antidepressants, antipsychotics, anxiolytics) that would impact the integrity of the data (e.g., naltrexone); No subject will be asked to stop taking medication to participate in the study;
* Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or her partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD;
* Contraindications to MRI such as claustrophobia or metal in their body;
* Subjects whose participation would cause them to exceed yearly radiation limits for research subjects

Contacts and Locations

Study Contact

Brittany N LeVasseur

CONTACT

2037375083

brittany.levasseur@yale.edu

Kelly Cosgrove, PhD

CONTACT

2037376969

kelly.cosgrove@yale.edu

Principal Investigator

Kelly Cosgrove, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06519

United States

Collaborators and Investigators

Sponsor: Yale University

Kelly Cosgrove, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-07

Study Completion Date2028-11-01

Study Record Updates

Study Start Date2023-11-07

Study Completion Date2028-11-01

Terms related to this study

Keywords Provided by Researchers

Alcohol
Alcohol cessation

Additional Relevant MeSH Terms

Alcohol Use Disorder