Alcohol Use Disorder study: [F-18]BCPP-EF vs [F-18]FDG
Official title Imaging Mitochondrial Complex-I in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT07825818
What this study is testing
What is [F-18]BCPP-EF?
An investigational radiotracer being studied for use in alcohol use disorder (AUD) research.
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 researchers want to see if mitochondrial Complex‑I function and brain glucose metabolism differ between those with alcohol use disorder and healthy people.
- Who it's for
- Adults who have alcohol use disorder and healthy adults matched for age and sex.
- What's involved
- Participants will undergo brain imaging scans that measure mitochondrial Complex‑I activity and glucose metabolism.
- 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 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Alcohol use disorders (AUD)
- Males or females between 18 and 55 years old
- fulfill DSM-5 criteria for alcohol use disorder
- History of NIAAA heavy drinking (for males, routinely consuming more than 4 drinks on any day or more than 14 drinks per week
- No other major DSM-5 psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, developmental disorders, or current...
See the full eligibility criteria
- Alcohol use disorders (AUD)
- Males or females between 18 and 55 years old
- fulfill DSM-5 criteria for alcohol use disorder
- History of NIAAA heavy drinking (for males, routinely consuming more than 4 drinks on any day or more than 14 drinks per week
- No other major DSM-5 psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, developmental disorders, or current depressive disorders (unless they are related to alcohol intoxication...
- No other DSM-5 substance use disorders including opioids, cocaine, amphetamines, sedative-hypnotics, hallucinogens, and inhalants.
- people not currently on psychotropic or medical medications that can influence binding to MC-I (e.g., metformin) or CGM (e.g., insulin, GLP-1 agonists), or increase the risks associated with an arterial line (e.g...
- No medical disorders that can influence the PET outcome measures (for example, MC-I binding is altered in Parkinson's disease, mild or major neurocognitive disorders, and mitochondrial disorders
- Not currently pregnant or breast-feeding
- Not currently employed as a radiation worker; or has participated in a radiation-related research protocol within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the...
- No medical or psychiatric contraindications to undergo an MRI scan (such as ferromagnetic tattoos/piercings, implants, medical equipment, history of gunshot, and claustrophobia). Healthy controls (HC)
- Males or females between 18 and 55 years old
- No current or past DSM-5 psychiatric or substance use disorders other than tobacco use disorder
- No history of heavy drinking as defined using NIAAA criteria in the past year
- 5 to 10 above.
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, 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, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburgh, Pennsylvania, 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.