Clinical trial NCT06137365: Cannabis for Obesity Trial
Official title: A Randomized, Placebo-Controlled Clinical Trial of Once Daily Oral Cannabis for Weight Loss in Obese Individuals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Obesity
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo and active cannabis groups
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Weight change
timeFrame: weekly for duration of 6-month trial
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: