Proof-of-concept trial of PP-01 for mitigating cannabis withdrawal syndrome in participants with cannabis use disorder.
Ashley F Slagle, Jay Constantine, Harvey Kushner et al.
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In 30 seconds
This Phase 1b/2a randomized, double-blind, placebo-controlled crossover trial assessed PP-01, a combination of nabilone and gabapentin, for cannabis withdrawal in 14 adults with moderate to severe cannabis use disorder. During a 5-night inpatient study, PP-01 significantly reduced withdrawal symptom severity (p = .0222) and bothersomeness (p = .0063) compared with placebo, with improvements reported within 10 and 4 h after the first dose, respectively. Sleep quality, cravings, and objective withdrawal measures also improved. PP-01 was well tolerated, with mild adverse events and no serious adverse events.
Key findings
- PP-01 reduced withdrawal symptom severity versus placebo (p = .0222), with improvement within 10 h of the first dose.
- Withdrawal symptom bothersomeness decreased versus placebo (p = .0063), with improvement within 4 h of the first dose.
- Sleep quality, cannabis cravings, and objective withdrawal measures improved following the first dose through discharge.
- Adverse events were mild, and no serious adverse events occurred.
Why it matters
Cannabis withdrawal can impede abstinence and contribute to relapse, while the abstract notes that no FDA-approved medication is available for cannabis withdrawal syndrome or cannabis use disorder. These proof-of-concept findings suggest that PP-01 may reduce withdrawal symptoms and related difficulties during early abstinence, warranting further evaluation before its role in care can be established.
What to keep in mind
The study included only 14 participants and lasted five inpatient nights, limiting the evidence on longer-term safety, effectiveness, and outcomes outside the inpatient setting.