Cannabis for Obesity Trial

Официальное название

A Randomized, Placebo-Controlled Clinical Trial of Once Daily Oral Cannabis for Weight Loss in Obese Individuals

Обзор

The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals.

Вмешательства

• Препарат Cannabis
  Cannabis gummy product will be prepared using cannabis flower extract.
• Препарат Placebo
  Placebo gummy product will be prepared using the same ingredients as the cannabis gummy but will not contain active cannabinoids.

Первичные конечные точки

• Weight change [Срок оценки: weekly for duration of 6-month trial]

Критерии участия

Критерии включения

• Male or female.
• Age 18-65 years.
• BMI >=30 kg/m2 (i.e., obese).
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in as assessed by one of the MD study personnel.
• Able to speak and read English.
• Apple or Android phone, or Android tablet with wi-fi or cellular service.
• Vital signs at Screening and Check-in as per the following ranges and stable (measured in a supine position after a minimum of 5 minutes of rest):

• Systolic blood pressure ≥ 90 and ≤ 140 mmHg
• Diastolic blood pressure ≥ 50 and ≤ 90 mmHg
• Pulse rate ≥ 50 and ≤ 100 bpm

Критерии исключения

• UK Students cannot participant
• Current cannabis use (e.g., past month; negative test for cannabinoids during screening) and no more than 15 self-reported lifetime uses.
• Self-reported current use of CBD.
• Severe past negative experience with cannabis or cannabinoid use (e.g., panic attack, anxiety).
• Use of any anti-obesity medication in the past 90 days. Specifically GLP-1 agonists (e.g., liraglutide, semaglutide, tirzepatide), SGLT-2 inhibitors (e.g., canagliflozin, dapagliflozin, empagliflozin, ertugliflozin), sulfonylureas (e.g., glimepiride, glipizide), medlitinides (e.g., repaglinide, nateglinide), Contrave, phentermine (alone or combination product such as Qsymia) or Orlistat. Stable use of metformin is permitted.
• Current treatment with insulin.
• History of type 1 diabetes.
• Stable body weight over the past 3 months. No changes greater than 5 kg.
• History of stomach or intestinal surgery or resection for obesity or otherwise (such as gastric bypass, sleeve-gastrectomy, bowel or small bowel resection) that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair > 6 months prior to Screening will be allowed).
• Obesity secondary to a known genetic, endocrine, or medical condition, such as polycystic ovarian syndrome, hypothyroidism, Cushing's syndrome, growth hormone deficiency, insulinoma, hypothalamic disorders (e.g., Froelich syndrome, Bardet-Biedl syndrome, Prader-Willi syndrome)
• Moderate or Severe Substance Use Disorder according to DSM-5 criteria; urine test positive for recent use of an abused drug.
• History of significant psychiatric disorder (e.g., bipolar, schizophrenia, depression, history of panic attacks).
• Current use of psychiatric medications (e.g., antipsychotics, antidepressants, anxiolytics).
• Current use of medications associated with hemodynamic instability (e.g., amphetamines, other sympathomimetic agents, atropine, scopolamine, other anticholinergic agents).
• Current use of medications that are inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) or CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice).
• A score of 15 or more on the Patient Health Questionnaire (PHQ-9).
• Current or past year history of one or more of the following disorders associated with overeating: rumination disorder, bulimia nervosa, severe/extreme binge eating disorder (>7 episodes per week) or other specified/unspecified feeding/eating disorder that would increase risk to the participant or complicate interpretation of the data. Individuals who report mild to moderate (<7 episodes per week) binge eating disorder are eligible.
• Female participant who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
• Male participant who is not using a highly effective contraceptive method or who has a female partner who is not using a highly effective contraceptive method.
• Any clinically important uncontrolled illness, medical/surgical procedure, or major trauma within 8 weeks prior to dose administration on Day 1.
• History of congestive heart failure or arrhythmias.
• Any of the following cardiovascular events in the past 3 months

• acute myocardial infarction
• cerebrovascular accident (stroke)
• unstable angina
• Lab-Screening Exclusion:

• Thyroid-stimulating hormone (TSH) level outside of the normal range, confirmed on repeat testing
• AST, ALT, or alkaline phosphatase >2x ULN
• EGFR <60 ml/min as calculated using the Cockroft-Gault equation.
• History of significant hypersensitivity, intolerance, or allergy to a cannabinoid or "gummy" product.
• Current use of any medications or supplement which would either compromise the validity of the study or the safety of the participant.
• History of seizure or predisposing factors for seizure (head trauma resulting in unconsciousness in past six months or CNS tumors).
• Meeting the following criteria from the Columbia Suicide Severity Rating Scale (C-SSRS):

• "yes" to Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or
• "yes" to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) or
• "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) and
• the ideation or behavior occurred within the past month.
• Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in an investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Kentucky — Lexington

Идентификаторы

NCT: NCT06137365 · 86131

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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