Adults 18 to 55, any sex, with Opioid Overdose. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clinical Opiate Withdrawal Scale (COWS)Primary· 4-week trial: Peak COWS score throughout the testing session for each dose combination.
Clinical Opiate Withdrawal Scale is an 11-item, clinician-administered measure designed to quantify the severity of opioid withdrawal. The COWS evaluates the severity of the following symptoms on a scale of 0-4 or 5: resting pulse rate, sweating, restlessness, pupil size, bone or joint aches, runny nose or tearing, gastrointestinal upset, tremor, yawning, anxiety, or irritability, and gooseflesh. The score on the COWS ranges from 0 to 48 points with withdrawal ratings between 5-12 considered mild, 13-24 as moderate, 25-36 as moderately severe, and \>36 considered severe.
Group
Value
95% CI
Naloxone 0 mg + MJ 0.0 mg
2
Naloxone 0 mg + MJ 12.5 mg
2
Naloxone 0 mg + MJ 25 mg
4
Naloxone 4 mg + MJ 0.0 mg
27
Naloxone 4 mg + MJ 12.5 mg
21
Naloxone 4 mg + MJ 25 mg
20
Sponsor's own description
The goal of the proposed, proof-of-concept study is to test the combined effects of vaporized marijuana \[Delta-9-tetrahydracannabinol (THC)\] with NLX as a proof of concept towards the possible development of a combined overdose reversal agent with improved tolerability.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by New York State Psychiatric Institute
Last refreshed: 18 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05114460.