Repurposing Semaglutide for the Treatment of Cocaine Use Disorder

Exclusion Criteria

• •Medical Exclusions
• •Personal or first-degree relative(s) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
• •History or presence of chronic pancreatitis or recent acute pancreatitis.
• •Type 1 or type 2 diabetes mellitus (previously diagnosed or indicated by HbA1C ≥48 mol/mol (6.5%) as measured at screening).
• •Severe gastrointestinal disease (i.e., severe gastroparesis).
• •History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
• •History of severe cardiovascular disease.
• •History of retinopathy.
• •Systolic blood pressure (SBP) \>180 mmHg and/or diastolic blood pressure (DBP) \>105 mmHg)
• •End stage renal disease (ESRD, previously diagnosed or indicated by estimated glomerular filtration rate (eGFR) value of eGFR \< 15 ml/min/1.73 m2 at screening).
• •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times the upper limit of normal range at screening.
• •Known or suspected hypersensitivity to semaglutide, excipients, or related products.
• •History of seizure or elevated risk of seizure.
• •Women who are currently pregnant, or plan to become pregnant, or lactating, or of childbearing potential and are not using medically accepted forms of contraception
• •Have any medical illness or condition which in the opinion of the PI and/or the Study Physician would preclude safe and/or successful completion of the study.
• •Any foreseeable procedure requiring general anesthesia or deep sedation.
• •Psychiatric/Substance Use Exclusions
• •Current ≥ moderate substance use disorder aside from alcohol, nicotine, or marijuana, or a Substance Use Disorder (SUD) requiring medical detoxification (e.g., alcohol, opioid, benzodiazepine)
• •Current or recent suicidal ideation.
• •Homicidal ideation that requires immediate attention.
• •Have any psychiatric illness or condition which in the opinion of the PI and/or the Study Physician would preclude safe and/or successful completion of the study.
• •Weight-Related Exclusions
• •Gained/lost ≥4.5 kg (10 lb.) over the past 6 months (prior to screening).
• •Uncontrolled thyroid disease at screening
• •Medication-Related Exclusions
• •Currently using sincalide, sulfonylureas, insulin and insulin products, or medication used for weight management (i.e., orlistat, naltrexone-bupropion, liraglutide, semaglutide, tirzepatide, phentermine, topiramate, benzphetamine, diethylpropion, phendimetrazine).
• •Any otherwise not specified concomitant medication that could compromise participant safety or treatment in the opinion of the Study Physician and/or the PIs.
• •General Exclusions
• •Current, anticipated, or pending enrollment in another addiction treatment program and/or research study that could potentially affect participant safety and/or the study data/design as determined by the Principal Investigator and/or Study Physician.
• •Not planning to live in the area for the duration of the trial.
• •Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the PI and/or the Study Physician.
• •Unable to communicate (read, write, and speak) fluently in English.