Cannabis for Obesity Trial

Launched by UNIVERSITY OF KENTUCKY · Nov 13, 2023

Keywords

ClinConnect Summary

The Cannabis for Obesity Trial is a clinical study aimed at finding out if taking cannabis once a day can help people who are obese lose weight. This trial is looking for adults aged 18 to 65 who have a body mass index (BMI) of 30 or higher, which means they fall into the obese category. To participate, individuals must be in generally good health and able to read and speak English. It's important to note that those currently using cannabis or certain weight-loss medications won't be eligible for this study.

Participants in this trial can expect to undergo some health screenings to ensure they meet the necessary criteria. If eligible, they will take cannabis daily to see if it helps them lose weight over the study period. The study is not yet recruiting participants, so it’s still in the planning stages. If you or someone you know is interested in this trial, keep an eye out for more information as it becomes available!

Gender

ALL

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.