Cannabis for Obesity Trial
ConditionObesity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJoshua A. Lile, Ph.D.
About this trial
The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Cannabis
DrugCannabis gummy product will be prepared using cannabis flower extract.
Placebo
DrugPlacebo gummy product will be prepared using the same ingredients as the cannabis gummy but will not contain active cannabinoids.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ActiveExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weight change
measured in kg using digital scale
Time frame
weekly for duration of 6-month trialSponsors and contacts
Click on the lead sponsor to view all of their trials.
Joshua A. Lile, Ph.D.
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov