BridgeMD
New treatment option for Addiction
Official title Semaglutide Therapy for Alcohol Reduction (STAR)
ClinicalTrials.gov ID: NCT06015893
What this study is testing
What is Semaglutide?
Semaglutide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for addiction.
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
- Background: Alcohol use disorder (AUD) is a problematic pattern of alcohol use accompanied by clinically significant medical consequences. Medications can help most people reduce their drinking, but the number is limited, and additional treatment options are needed.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 20 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 110
You may be able to join if
- This study will enroll adult individuals with a current diagnosis of AUD. Participants will be recruited without any preference to sex, race...
- At least 18 years old
- Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., the Mini-International Neuropsychiatric Interview (MINI) or the...
- Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of \> 7 drinks per week for females or \> 14 drinks per week for males...
- Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \< 10
You likely can't join if
- An individual who meets any of the following criteria will be excluded from enrolling in this study:
- BMI \ = 50 kg/m\^2
- Evidence of malnutrition as determined by the Nutrition Risk Screening 2002 (NRS-2002)
- Most recent blood tests: creatinine \>= 2 mg/dL, eGFR \ 500 mg/dl, ALP \> 4x the upper limit of normal, clinically abnormal lipase levels per study...
- Present diagnosis of diabetes mellitus or blood hemoglobin A1c (HbA1c) \>= 6.5 %
- Current (within the past 30 days) use of the following medications with glucose lowering properties: GLP-1 analogues, sulfonylurea, insulin...
See the full eligibility criteria
- This study will enroll adult individuals with a current diagnosis of AUD. Participants will be recruited without any preference to sex, race, religion, or other social variables, but sociodemographic data will be...
- At least 18 years old
- Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., the Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))
- Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of \> 7 drinks per week for females or \> 14 drinks per week for males during the 28-day period prior to screening plus at least four days with...
- Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \< 10
- Able to speak, read, write, and understand English as demonstrated by ability to understand and sign the NIDA screening protocol consent
- Normal or corrected-to-normal (e.g., wearing glasses or contacts) vision and normal or corrected-to-normal (e.g., with the use of a hearing aid) hearing
- An individual who meets any of the following criteria will be excluded from enrolling in this study:
- BMI \ = 50 kg/m\^2
- Evidence of malnutrition as determined by the Nutrition Risk Screening 2002 (NRS-2002)
- Most recent blood tests: creatinine \>= 2 mg/dL, eGFR \ 500 mg/dl, ALP \> 4x the upper limit of normal, clinically abnormal lipase levels per study clinician
- Present diagnosis of diabetes mellitus or blood hemoglobin A1c (HbA1c) \>= 6.5 %
- Current (within the past 30 days) use of the following medications with glucose lowering properties: GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors...
- Current or prior use of semaglutide or tirzepatide
- Current (within the past 30 days) use of weight-lowering medications
- Current (within the past 30 days) use of FDA-approved pharmacotherapy for AUD (oral or intramuscular naltrexone, acamprosate, disulfiram)
- Current (within the past 30 days) use of medications with known interaction with semaglutide
- Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Known ongoing history of alcohol ketoacidosis, gastroparesis, pancreatitis (either acute or chronic), pancreatic carcinoma, gallbladder disease, jaundice, Mallory-Weiss syndrome (esophageal tears secondary to vomiting)...
- Known history of gastric bypass surgery
- Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue
- Known history of suicidal attempts (within the past 24 months) or active suicidal ideation
- Known history of clinically significant vestibular disorders or motion sickness
- Known history of clinically significant noise-induced hearing loss or tinnitus
- Contraindication(s) for brain fMRI
- Unstable cardiovascular conditions (e.g., arrhythmias, clinically significant ECG abnormalities)
- Physical and/or mental health conditions that are clinically unstable, as determined by the study clinicians, including (but not limited to) major depressive disorder or generalized anxiety disorder unstable during the...
- Female who is pregnant, breast-feeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
- Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, 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 - confirm specifics with the study team.
How long does this study last?
The study runs about 20 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 110 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, 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.