Cannabis for Obesity Trial

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

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Cannabis
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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 Exclusion Criteria 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 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. 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. 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). 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo and active cannabis groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Cannabis gummy, starting at 2.5 mg THC and increased weekly by 2.5 mg increments up to a maximum target dose of 15 mg THC, administered once daily for duration of 6-month trial participation. | Drug: Cannabis<br>* Cannabis gummy product will be prepared using cannabis flower extract.<br>|
| Placebo Comparator: Placebo<br>Placebo cannabis gummy, containing no active THC, administered once daily for duration of 6-month trial participation. | Drug: Placebo<br>* Placebo gummy product will be prepared using the same ingredients as the cannabis gummy but will not contain active cannabinoids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | measured in kg using digital scale | weekly for duration of 6-month trial |