Alcohol Use Disorder study: Intravenous Ethanol vs 18F-PF-06445974
Official title Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B)
ClinicalTrials.gov ID: NCT07027839
What this study is testing
What is Intravenous Ethanol?
Intravenous Ethanol is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for alcohol use disorder.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if alcohol raises the activity or amount of a brain protein called phosphodiesterase‑4B (PDE4B).
- Who it's for
- Adults ages 21‑70 who drink socially but do not have alcohol use disorder.
- What's involved
- You will attend up to four clinic visits: a 6‑hour visit for a baseline PET scan with a radioactive tracer and blood draws, a 14‑16‑hour visit for a PET scan after IV alcohol is given to reach the legal driving limit, and a separate visit for a brain MRI that takes about 2 hours.
- Time commitment
- The study lasts several weeks and includes one 6‑hour visit, one 14‑16‑hour visit, and one 2‑hour MRI visit.
- 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
You may be able to join if
- Be enrolled in protocol 14-AA-0181, NIAAA Natural History Protocol.
- Age 21 - 70 years.
- Willingness to complete the study including MRI tests.
- Be in good general health as evidenced by medical history and physical examination.
- Participants must have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or...
You likely can't join if
- History of AUD or SUD. Participants may currently use cannabis recreationally but cannot meet criteria for cannabis use disorder, or present for...
- Current non-drinkers (alcohol-naive individuals or no use of alcohol in the past year), or individuals with no experience drinking 5 or more drinks...
- Current or prior history of alcohol-induced flushing reactions, including rapid reddening of the face, rapid heart rate and breathing, and nausea...
- Clinically significant abnormalities on EKG or laboratory tests: CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen), liver...
- Participants who have taken an antipsychotic or antidepressant medication within two weeks prior to the PET scan #1, with longer washout times of 1...
- Medication exclusion for alcohol: 6a. Use of prescription or OTC medication known to interact with alcohol 2 weeks prior to screening or screening...
See the full eligibility criteria
- Be enrolled in protocol 14-AA-0181, NIAAA Natural History Protocol.
- Age 21 - 70 years.
- Willingness to complete the study including MRI tests.
- Be in good general health as evidenced by medical history and physical examination.
- Participants must have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.
- Able to provide informed consent.
- History of AUD or SUD. Participants may currently use cannabis recreationally but cannot meet criteria for cannabis use disorder, or present for study visits with positive urine drug screen for THC.
- Current non-drinkers (alcohol-naive individuals or no use of alcohol in the past year), or individuals with no experience drinking 5 or more drinks on one occasion in their lifetime.
- Current or prior history of alcohol-induced flushing reactions, including rapid reddening of the face, rapid heart rate and breathing, and nausea after 1 or 2 drinks.
- Clinically significant abnormalities on EKG or laboratory tests: CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen), liver function tests (GGT, AST, ALT, bilirubin).
- Participants who have taken an antipsychotic or antidepressant medication within two weeks prior to the PET scan #1, with longer washout times of 1 month for antidepressants with longer half-lives such as fluoxetine.
- Medication exclusion for alcohol: 6a. Use of prescription or OTC medication known to interact with alcohol 2 weeks prior to screening or screening update visit. These include but may not be limited to: isosorbide
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.