RecruitingPhase 2

Cannabis for Obesity Trial

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether cannabis taken by mouth once a day may help people with obesity lose weight. It is for adults ages 18–65 who have a BMI of 30 or higher and are otherwise in good health.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men and women ages 18–65.
  • BMI of 30 or higher. BMI is a measure of weight compared with height.
  • In good health based on a study doctor's review, exam, heart test, and lab tests.
  • Able to speak and read English.
  • Have an Apple or Android phone, or an Android tablet, with Wi-Fi or cell service.
  • Have stable blood pressure and pulse at screening and check-in after resting while lying down for at least 5 minutes.
  • Blood pressure: top number 90–140 and bottom number 50–90.
  • Pulse: 50–100 beats per minute.

Who can't join

  • UK students cannot join. The listing does not explain what “UK” means.
  • Current cannabis or CBD use, a severe bad reaction to cannabis, or an allergy to cannabis-related or gummy products. The rules about lifetime cannabis use are unclear; ask the study team.
  • Weight-loss medicines in the past 90 days, certain diabetes medicines, current insulin use, or type 1 diabetes. Stable metformin use is allowed. The listing also puts stable weight under exclusions; ask the team to clarify.
  • Past stomach or bowel surgery that could affect how the body handles the study drug, or obesity caused by another known medical condition. Some minor surgeries are allowed.
  • A serious mental health condition, certain eating disorders, moderate or severe substance use disorder, or a positive drug test. Certain depression scores or suicidal thoughts or actions in the past month also exclude people.
  • Pregnancy, breastfeeding, or plans to become pregnant. Required highly effective birth control must be used by participants and partners as described by the study.
  • Certain medicines, supplements, or grapefruit juice that may affect safety or study results. These include mental health medicines and drugs that affect blood pressure, pulse, or how the body breaks down the study drug.
  • Certain heart problems, seizures or seizure risks, abnormal thyroid, liver, or kidney tests, or recent serious illness, surgery, or injury. Other concerns about safety or ability to follow study rules may also prevent joining.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 * 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.

Study sites (1)

KY