BridgeMD
New treatment option for Alcohol Use Disorder
Official title Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
ClinicalTrials.gov ID: NCT06405607
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, 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
- This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 65
You may be able to join if
- Weight between 50kg and 150kg
- No known allergies to rescue medication
- For people capable of becoming pregnant, not pregnant and using contraception
- Not currently breastfeeding
- Meets criteria for DSM-V moderate to severe AUD.
You likely can't join if
- Drug/medication assessment that yields: nonprescription medication use, nutritional supplement, or herbal supplement (except when approved by the...
- Psychiatric assessment that yields:1) history of severe suicide attempt, 2) current suicidality 3) first-degree relative with schizophrenia or...
- Medical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation [QTc \> .045]), serious...
- MRI contraindication (pacemaker, etc.)
See the full eligibility criteria
- Weight between 50kg and 150kg
- No known allergies to rescue medication
- For people capable of becoming pregnant, not pregnant and using contraception
- Not currently breastfeeding
- Meets criteria for DSM-V moderate to severe AUD.
- Have at least 4 heavy drinking days (5 or more standard drinks in a day) in the past 30 days.
- Not currently participating in formal treatment for AUD.
- No history of a of cerebrovascular accident, asthma, or significant alcohol withdrawal history
- No seizure disorder, coronary artery disease, heart failure, uncontrolled hypertension, insulin-dependent diabetes, pancreatitis, liver disease
- No hallucinogen or ketamine use in past 12 months
- No self-reported, personal, or familial history of specific psychotic disorders/episodes.
- No serious traumatic brain injury (TBI) in the past 2 years
- No substance use disorder other than AUD over the past 12 months
- If taking a GLP-1 agonist, stable dosage for past 3 months
- Family member/friend for pick-up, overnight post-drug session monitoring.
- No MRI contraindications
- Drug/medication assessment that yields: nonprescription medication use, nutritional supplement, or herbal supplement (except when approved by the study investigators), medically unstable, current medication use that has...
- Psychiatric assessment that yields:1) history of severe suicide attempt, 2) current suicidality 3) first-degree relative with schizophrenia or schizoaffective disorder, 4) comorbid substance use disorder including...
- Medical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation [QTc \> .045]), serious abnormalities of complete blood count or chemistries, medical conditions...
- MRI contraindication (pacemaker, etc.)
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, 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.