Investigating the Mu:Kappa Opioid Receptor Imbalance in Alcohol Use Disorder (NCT05957159) | Clinical Trial Compass
RecruitingEarly Phase 1
Investigating the Mu:Kappa Opioid Receptor Imbalance in Alcohol Use Disorder
United States100 participantsStarted 2023-11-07
Plain-language summary
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.
Who can participate
Age range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion Criteria:
* 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 l…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Regional binding availability and volume of distribution of (Mu-Opioid receptors)
Timeframe: Within first 6 days of abstinence
2
Regional binding availability and volume of distribution of (Mu-Opioid receptors)
Timeframe: Between 3 to 6 weeks into alcohol cessation
3
Regional binding availability and volume of distribution of (Kappa-Opioid receptors)
Timeframe: Within first 6 days of abstinence
4
Regional binding availability and volume of distribution of (Kappa-Opioid receptors)
Timeframe: Between 3 to 6 weeks into alcohol cessation
5
Alcohol Cue Reactivity Craving
Timeframe: Within first 6 days of abstinence
6
Change in Alcohol Withdrawal
Timeframe: Up to 1 month prior to initial imaging and up to 6 days into alcohol cessation
7
Change in Alcohol Use
Timeframe: Up to 1 month prior to initial imaging and up to 6 days into alcohol cessation