In collaboration with the University of Kentucky Markey Cancer Center, the Cannabis Center is preparing to conduct one of the first double-blind, placebo-controlled, randomized, controlled trials of repeated doses of cannabis in patients with cancer.

Study Overview

• Once daily dosing for four months (cannabis gummy)
• Doses titrated at study start, and tapered at the end
• Daily check-ins with study staff
• Daily data collection with OnTrackA data app
• Observed daily dosing on FaceTime
• Once monthly in-person visits

Principle Investigators

Zin Myint, MD

Shanna Babalonis, PhD

Co-Investigators and Collaborators

Donglin Yan, PhD

Jerod Stapleton, PhD

Jill Kolesar, PhD

Study Progress

Projected Start Date: February 2024

This study is currently under review at UK Markey Cancer Center. After the Markey Cancer Center review, we will submit the protocol for other regulatory reviews (UK Institutional Review Board (IRB), US FDA, and DEA). We have experienced some delays with drug supply; however, we have a new supplier, and anticipate receiving drug supplies in the beginning of 2024.

Barriers and Solutions: 

Drug Supply: We had been working with a cannabis company for over one year to secure drug supply for this study (and other studies). The company's research operation collapsed(Spring 2023) and they were unable to fulfill their supply commitments. Importantly - we did not lose any money (we had not paid them anything per our agreement); however, we lost a great deal of time.

New Drug Supply: We are now working with a highly reputable company, ElSohly Laboratories, to obtain drug supply. The CEO of the company, Mahmoud ElSohly, also serves as the director of the NIDA Marijuana Farm at the University of Mississippi.

Preparing for Study Launch:

Study Staff: We have hired a research nurse (Lelia Andrews, RN, BSN) and a study coordinator (Grayson Fuller, BS, MPH) for this study. UK Center on Drug and AlcoholResearch Project Director, Paul Nuzzo, MA is also contributing to this study. This team meets regularly to develop protocols for drug delivery and security, safety assessments, data collection, and daily dosing.

The Cannabis Center is collaborating with the UK Barnstable Brown Diabetes Center and the division of endocrinology in the UK College of Medicine Internal Medicine Department to conduct the first double-blind, placebo-controlled, randomized trial of daily cannabis doses in patients with pre-diabetes and obesity.

The goal of this study is to determine the safety, tolerability, and initial efficacy of once-daily, oral cannabis for weight-loss and metabolic health in obese individuals. 

Study Rationale

• Kentucky is #2 in the US for the highest rates of adult obesity, with four in 10 adults meeting criteria for obesity.
• Obesity increases the risk of many medical conditions, including stroke, type 2 diabetes, hypertension, heart disease, cancer, and several others.
• The Cannabis Center recognizes that there are FDA-approved treatments for obesity and related conditions; however, additional treatments should be investigated.
• Population-based studies consistently report that frequent cannabis users have lower BMIs and better metabolic health than controls.
• There have been no controlled studies in humans to determine if this protective effect is produced by cannabis use itself, or if this finding may be attributed to another factor.

Study Design

A randomized, double-blind, placebo controlled, between-subject trial of cannabis for the treatment of obesity.

Primary Outcomes

1. Safety and tolerability of daily cannabis doses
2. Changes in body weight

Secondary Outcomes

Cannabis-induced changes in:

• Waist circumference
• Heart rate and blood pressure
• Insulin
• Blood glucose
• Lipids (triglycerides, HDL and LDL cholesterol)
• Omega-6 and omega-3 fatty acids
• Hemoglobin A1C (HbA1c)
• Hunger hormones (leptin, ghrelin, PYY)
• Drug use patterns (licit and illicit drug use)
• Endogenous cannabinoids (AEA, 2-AG)

Investigator Team

Joshua Like, PhD
Principal Investigator

Simon Fisher, MD, PhD
Chief, Division of Endocrinology

Kamyar Asadipooya, MD
Assistant Professor

Christopher Alcorn, DO
Fellow, Department of Internal Medicine

Shanna Babalonis, PhD
Associate Professor

Study Progress

Projected Start Date: February 2024

The study has been approved by the UK Medical IRB. We are preparing applications for additional regulatory reviews (US, FDA, and DEA). The Center experienced some delays with drug supplies; however we anticipate receiving drug supply in the beginning of 2024.

Preparing for Study Launch:

Study Staff and Research Preparation: Karen Shearer from the UK Barnstable Brown Diabetes Center will serve as the lead study coordinator for this study.

Similar to the Cancer Trial, this study will utilize app-base data collection methodology through OnTracka (an encrypted, HIPAA-compliant, secure service).

The research team meets regularly to develop protocols for drug delivery and security, safety assessments, data collection, and daily dosing protocols.

Researchers at the Center on Drug and Alcohol Research and the UK Cannabis Center received an $2.8 million NIH Grant in 2022 (NIH R01 DA 054347)

The team at the UK Cannabis Center and Center on Drug and Alcohol Research have recently completed two NIH-funded research studies. We are presenting an overview of the data here to 1) inform the state of our recent findings and 2) demonstrate the capabilities of our multidisciplinary research team as we expand our cannabis research portfolio.

Key Finding

Data

Cannabidiol (CBD) does not decrease the high or abuse potential of cannabis

• Cannabis containing THC alone and cannabis containing THC+ CBD was tested
• The addition of CBD did not decrease the THC-related high reported by participants
• In some cases, THC+CBD increased the subjective effects relative to THC alone

At high doses, cannabis + opioid combinations produce increased abuse potential

• Inhaled cannabis combined with intranasaloxycodone increases participant ratings of drug liking and feeling high
• This study joins several others with similar findings; these data are potentially concerning for those who use these drugs together for therapeutic or non-medical use

Cannabis did not alter the safety profile of opioids and did not alter opioid analgesia

• Cannabis did not change the physiological risk of opioids - there were no changes in opioid-induced respiratory function
• Cannabis did not alter opioid analgesia, suggesting it may not provide additional benefit to those taking opioids
• These findings suggest these are safe drug combinations to explore for therapeutic effects

Investigators:

Shanna Babalonis, PhD

Michelle Lowfall, MD

Sharon Walsh, PhD

Laura Fanucchi, MD

Kevin Hatton, MD, PhD

Objectives

The goal of this study is to examine the effects of inhaled cannabis across a wide dose range to determine how these doses modulate:

1. opioid withdrawal severity
2. opioid abuse potential
3. opioid physiological effects/safety outcomes

Study Progress

Projected Start Date: February 2024

The study protocol has been approved by all necessary regulatory bodies (UK Medical IRB, FDA, and DEA). The Center experienced some delays with drug supply; however, we anticipate receivingdrug supply in the beginning of 2024