Small inpatient trial finds PP-01 eased cannabis withdrawal symptoms

Proof-of-concept trial of PP-01 for mitigating cannabis withdrawal syndrome in participants with cannabis use disorder.

The American journal on addictions • • Highly Relevant
🤖

AI Summary

This Phase 1b/2a randomized, double-blind, placebo-controlled crossover study examined whether PP-01—a combination of the cannabinoid drug nabilone and gabapentin—could reduce cannabis withdrawal symptoms in 14 adults with moderate to severe cannabis use disorder. Participants were monitored during a 5-night inpatient stay after receiving PP-01 or placebo.

Compared with placebo, PP-01 significantly reduced both the severity and bothersomeness of withdrawal symptoms within hours of the first dose. Participants also reported improved sleep quality and reduced cannabis cravings, while objective withdrawal measures improved as well. PP-01 was well tolerated in this study: reported adverse events were mild, and there were no serious adverse events. However, this was a small, short proof-of-concept trial, so the abstract cannot establish whether PP-01 supports long-term abstinence, prevents relapse, or works broadly outside an inpatient setting. This is an abstract-based summary, not a review of the full text.

💡 Key Findings

1
In 14 adults with moderate to severe cannabis use disorder, PP-01 significantly reduced the severity of cannabis withdrawal symptoms compared with placebo within 10 hours of the first dose.
Moderate
55%
2
PP-01 significantly reduced the bothersomeness of withdrawal symptoms within 4 hours of the first dose and improved reported sleep quality and cannabis cravings through discharge.
Moderate
55%
3
PP-01 was well tolerated during the 5-night inpatient study; adverse events were mild, with no serious adverse events reported.
Moderate
55%
4
Because this was a small, short proof-of-concept study, the findings do not establish long-term effectiveness, relapse prevention, or generalizability to outpatient treatment.
High
90%

📄 Original Abstract

BACKGROUND AND OBJECTIVES: Cannabis withdrawal symptoms can be severe and protracted, significantly impeding the ability to abstain from cannabis use, resulting in failed quit attempts and relapse. This clinical trial evaluated safety and efficacy of PP-01, a novel dual‑mechanism of action, investigational agent, for mitigating cannabis withdrawal symptoms in patients with cannabis use disorder (CUD). METHODS: This Phase 1b/2a randomized, double-blind, placebo-controlled, crossover, 5-night, inpatient study evaluated efficacy and safety of PP-01 (nabilone and gabapentin) in 14 adults with moderate to severe CUD. Participants with daily/near daily use of ≥1 gram/day of cannabis and a history of cannabis withdrawal were randomized to PP-01 or placebo. Severity and bothersomeness of withdrawal symptoms were evaluated by patient daily diary. Mixed model repeated measures analysis of variance was used to compare mean differences between PP-01 and placebo. RESULTS: PP-01 significantly reduced severity (p = .0222) and bothersomeness (p = .0063) of cannabis withdrawal symptoms within 10 and 4 h post-first dose of PP-01, respectively. Sleep quality and cannabis cravings significantly improved following first dose through discharge. Objective withdrawal measures also statistically significantly improved. PP-01 was well tolerated; adverse events (AEs) were mild in severity with no serious AEs. DISCUSSION AND CONCLUSIONS: Investigational PP-01 mitigated cannabis withdrawal symptoms in participants with moderate to severe CUD, was safe and well-tolerated in this proof-of-concept study. SCIENTIFIC SIGNIFICANCE: PP-01 is intended as a potential treatment for cannabis withdrawal syndrome (CWS)/CUD, a serious and unmet need for which there is no Food and Drug Administration (FDA)-approved medication.

Explore More Research

Stay informed about the latest cannabis science.

Your stash, decoded.