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New treatment option for Alcohol Use Disorder
Official title Investigating the Mu:Kappa Opioid Receptor Imbalance in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT05957159
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Participants with AUD will have a current diagnosis of AUD according to DSM-5 criteria (i.e., SCID-5 ascertained diagnosis, confirmed by the...
- 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...
- Participants with AUD will indicate willingness to abstain from alcohol and engage in a quit attempt;
- Healthy people will have no current or past diagnosis of AUD or other significant substance use disorder. They will drink less than 5 alcoholic...
- Able to read and write English and to provide voluntary, written informed consent;
You likely can't join if
- Current significant medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology that would impact the...
- Past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain...
- Current significant psychiatric disorder including severe substance use disorder (other than alcohol or tobacco use disorders\ ), and past or current...
- Regular use in the past 6 months of any prescription, psychoactive or herbal medications (e.g., antidepressants, antipsychotics, anxiolytics) that...
- 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...
- Contraindications to MRI such as claustrophobia or metal in their body;
See the full eligibility 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...
- Participants with AUD will indicate willingness to abstain from alcohol and engage in a quit attempt;
- Healthy people 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...
- 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...
- 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...
- 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...
- 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...
- Contraindications to MRI such as claustrophobia or metal in their body;
- people whose participation would cause them to exceed yearly radiation limits for research people
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.