You are here
Home > News > ‘Cannabis Use Disorder’ Pill Clinical Trial To Begin

‘Cannabis Use Disorder’ Pill Clinical Trial To Begin

Smoking too much cannabis and it’s beginning to affect your life in negative ways? A drug that comes in capsules could soon be available, provided pharmaceutical drug makers get their way.

Segal Trials, a South Florida-based clinical trial network, announced that it would conduct Phase 2B studies to examine AEF0117202, a drug created by Aelis Farma for treating cannabis-use disorder (CUD), in a press release. This is a prospective, multicenter, randomized, placebo-controlled study that examines the effectiveness of drug which reacts to THC’s same receptors.

Under a new pharmacological class of drugs, called sCB1-SSi, AEF0117-202 is the first clinical candidate for the treatment of CUD, which is often defined as the inability to stop using cannabis—even if it’s causing health and social problems.

Is there a limit to how much cannabis you can consume? In this study the CUD criteria is people who use cannabis more than five times per week. One group of participants will get the drug orally, while another group will be administered a placebo. This will allow researchers to determine whether the pill is effective. Researchers will then begin to evaluate the effectiveness of the drug.

Three doses—1.0, 0.3, and 0.1 mg—and a placebo were given to study participants in capsules. “AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis’s effects,” researchers wrote in the summary. In the press release, they explained how their reasoning worked.

“Chronic marijuana use can drastically impact individuals’ social and professional lives in many ways, from poor work or school performance to mood disorders,” said Rishi Kakar, MD, chief scientific officer and medical director at Segal Trials. “This Phase 2B study gets us closer to the prospect of effectively treating people who want to end their reliance on cannabis but don’t have the tools to quit.”

“Addiction” can mean many different things, ranging from severe physical withdrawal symptoms from drugs like opiates or alcohol, or unhealthy psychological patterns. This study’s summary describes cannabis withdrawal symptoms as including irritability, mood and sleep difficulties, decreased appetite, cravings, restlessness, and occasionally physical discomfort.

The Centers for Disease Control and Prevention estimates that about 3 out 10 cannabis users have CUD. A second study found that cannabis users are approximately 10% likely to develop an addiction.

Researchers Blame Potency in Rise of CUD

It is believed that the reason for the increase in cannabis-related disorders has been the growth in marijuana use and the development of stronger and better concentrates.

“The potency of cannabis products has increased significantly over the past twenty years,” which may have contributed to the rise of cannabis-related adverse effects,” said Dr. Kakar. “With no approved drugs available to treat chronic cannabis use, Aelis Farma’s drug has the potential to make a significant, positive impact for millions of marijuana users seeking to end their dependence on cannabis.”

Segal’s team will run the trial in its Center for Psychedelic and Cannabis Research. It was designed using pharmaceutical and regulatory feedback and is structured to ensure patient safety and comfort. 

Noticeably, this team has worked with psychedelics. Segal Trials announced that they were the first to do a large, randomized clinical trials to examine MM120 (LSD D -tartrate), in order to treat Generalized Anxiety Disorder.

Segal is credited with having developed 54 FDA-approved drugs and devices. The company says that its trials focus on psychiatry, neurology, addiction, insomnia, infectious diseases, vaccine development, and women’s health.