PP-01 for Cannabis Withdrawal
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new treatment, PP-01, can reduce withdrawal symptoms for individuals trying to quit cannabis. Participants will receive either a high or low dose of PP-01, a placebo, or other known treatments such as nabilone or gabapentin. The trial targets those with moderate to severe Cannabis Use Disorder (CUD) who are attempting to reduce their cannabis use and experience significant withdrawal symptoms. Individuals who have used cannabis heavily almost every day and wish to manage withdrawal symptoms while quitting may find this trial suitable. As a Phase 2 trial, this research measures the effectiveness of PP-01 in an initial, smaller group, providing an opportunity to contribute to significant findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on stable psychotropic medication for at least 3 months, you may be included at the investigator's discretion.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that PP-01 is neither toxic nor harmful. Previous safety data indicate no major risks to people or the environment. It is neither irritating nor corrosive, making it generally safe to handle.
The trial also includes nabilone and gabapentin as treatments. Nabilone, a synthetic version of THC (the active ingredient in cannabis), is already approved for other uses, such as alleviating nausea in chemotherapy patients, suggesting its safety for humans. Gabapentin, commonly used for nerve pain and seizures, is well-known and generally safe when used as directed.
Overall, these findings suggest that the treatments in the trial are well-tolerated. However, like any treatment, side effects may occur, so discussing potential risks with the study team or a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Most treatments for Cannabis Withdrawal Syndrome, like nabilone and gabapentin, focus on alleviating symptoms without directly addressing the underlying withdrawal process. However, PP-01 is unique because it potentially targets the brain's cannabinoid receptors differently, offering a novel mechanism of action that could more effectively manage withdrawal symptoms. Researchers are particularly excited about PP-01 because of its potential to be titrated to high or low doses, offering flexibility based on individual patient needs. Additionally, the treatment's oral administration over a relatively short period (34 days) could enhance patient compliance and convenience compared to traditional therapies.
What evidence suggests that this trial's treatments could be effective for Cannabis Use Disorder?
Researchers are still conducting studies to determine how well PP-01 works for Cannabis Withdrawal Syndrome, and specific data from human studies remains limited. However, the mechanism of PP-01 appears promising. It likely helps by adjusting brain chemicals involved in withdrawal symptoms. Early studies on similar treatments suggest that targeting these brain pathways can reduce withdrawal effects. The ongoing trial will test various doses of PP-01, including high and low doses, to confirm its effectiveness in easing withdrawal symptoms in heavy cannabis users.678910
Who Is on the Research Team?
Jay Constantine, MD
Principal Investigator
PleoPharma, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive study medication for 34 days to mitigate cannabis withdrawal symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PP-01
Find a Clinic Near You
Who Is Running the Clinical Trial?
PleoPharma, Inc.
Lead Sponsor