Clinical trial for Alcohol Use Disorder (AUD)
Official title Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD)
ClinicalTrials.gov ID: NCT07559500
What this study is testing
What is Tirzepatide?
an investigational once-weekly injectable medicine being studied as a potential treatment for alcohol use disorder (AUD) is designed to activate GLP-1 and GIP receptors, which helps regulate blood sugar and appetite
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 is testing whether a drug called tirzepatide changes how the brain works. It looks at brain activity in people with alcohol use disorder.
- Who it's for
- You may be able to join if you are 21 to 65 and have alcohol use disorder. You must not be looking for treatment right now.
- What's involved
- You would get a shot under the skin once a week for a few weeks. You would also have brain scans and tests for thinking and memory.
- Time commitment
- The study lasts about two months with several visits for scans and tests.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, 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
- Enrollment in 14AA0181.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ages 21-65 years old.
- Ability to understand and willingness to sign a written informed consent document.
- Enrollment in 14AA0181.
You likely can't join if
- All Participants (Healthy Volunteers and AUD)
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard...
- Cannot lie comfortably flat on his/her back for up to 2 hours in the PET/MRI scanner.
- BMI \ 35 (but no more than 500 lbs). The PET/MRI scanner bed is tested to a weight limit of 500 lbs.
- Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual...
- Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 55 or less will undergo a...
See the full eligibility criteria
- Enrollment in 14AA0181.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ages 21-65 years old.
- Ability to understand and willingness to sign a written informed consent document.
- Enrollment in 14AA0181.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ages 21-65 years old.
- Ability to understand and willingness to sign a written informed consent document.
- DSM 5 diagnosis of mild to moderate AUD.
- Have or had any prior experience with stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, or prescription stimulants (prescription or recreational use), whether or not they have had a...
- Minimum 2-year history of heavy drinking (SAMSHA s criteria for heavy drinking: for men 5 or more drinks/day on at least 5 different days per month
- Non treatment seeking AUD participants.
- All Participants (Healthy Volunteers and AUD)
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI
- Cannot lie comfortably flat on his/her back for up to 2 hours in the PET/MRI scanner.
- BMI \ 35 (but no more than 500 lbs). The PET/MRI scanner bed is tested to a weight limit of 500 lbs.
- Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.
- Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 55 or less will undergo a urine pregnancy test and it must be negative to continue participation.
- Women using oral contraceptives (Part 2 of study). Women of childbearing age who are taking oral contraceptives will be required to switch to a non-oral hormonal contraceptive method (ie implants, injections, or IUDs)...
- Severe head trauma with loss of consciousness \> 60 minutes
- Current severe mental illness (schizophrenia, bipolar disorder).
- Montgomery-Asberg depression rating scale (MADRS) total score \> 35 or suicidal thoughts item score \> 3, indicating severe depression or moderate suicidality, respectively.
- Thyroid cancer or family history of thyroid cancer or personal or family history of multiple endocrine neoplasia syndrome type-2 (MEN-2).
- History for cerebral aneurysm.
- Past or present history of chest pain and trouble breathing with activity.
- History of Heart Disease, Hypertension or Cardiovascular disorders.
- History of seizures, anxiety, panic attacks, psychosis or glaucoma which are contraindicated with receiving methylphenidate.
- History of gallbladder disease, pancreatitis, gastroparesis, diabetic retinopathy, acute kidney injury (AKI), as these are contraindicated for Tirzepatide.
- History of allergic reaction to methylphenidate, Tirzepatide or allergic reactions to dyes or preservatives.
- Major medical problems that can permanently impact brain function (e.g., seizures, psychosis, stroke, Alzheimer s disease, Parkinson s disease, traumatic brain injury with loss of consciousness \> 30 minutes, clinically...
- Clinically significant laboratory findings that could impact brain function or study procedures (e.g., active infections, significant EKG results, hepatic or renal failure) will be exclusionary.
- Current DSM-5 diagnosis of a psychiatric disorder that required daily psychoactive medications (antidepressant, antipsychotics, stimulants, opioids, benzodiazepines or barbiturates) in the past two months and that could...
- History of moderate or severe SUD (other than nicotine in HV s, and nicotine, cannabis or alcohol for AUD participants).
- Daily current use (past 2 months) of the following drugs/medications are exclusionary: stimulant or stimulant-like drugs or medications (cocaine, methamphetamine, amphetamine, methylphenidate, modafinil)
- \ Non-English speakers (must also be able to read and comprehend English
- If a subject s breath alcohol (\>0.08%) screen test is positive on days involving imaging (PET/MRI) and NP testing, the procedures will be postponed and rescheduled.
- If urine drug screen is positive for THC-COOH a saliva drug screen will be performed and subject may proceed with study day testing procedures if saliva results for THC are negative.
- If a participants urine drug screen test is positive for cocaine, heroin or methamphetamine after 3 days of rescheduling they will be excluded.
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 65 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.