NCT06137365招募中2 期
A Randomized, Placebo-Controlled Clinical Trial of Once Daily Oral Cannabis for Weight Loss in Obese Individuals
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Weight change
研究概览
简要总结
The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Only investigator-level study personnel will have access to group assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo cannabis "gummy", containing no active THC, administered once daily for duration of 6-month trial participation.
干预措施: Placebo (Drug)
Active
Experimental
Cannabis "gummy", starting at 5 mg THC and increased every three weeks by 5 mg increments up to a maximum target dose of 15 mg THC, administered once daily for duration of 6-month trial participation.
干预措施: Cannabis (Drug)
结局指标
主要结局
Weight change
时间窗: weekly for duration of 6-month trial
measured in kg using digital scale
次要结局
未报告次要终点
研究者
Joshua A. Lile, Ph.D.
Professor
University of Kentucky
研究点 (1)
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