Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal

NCT05114460 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 8061
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Overdose

Outcome Measures

Primary Outcomes (1)

• Clinical Opiate Withdrawal Scale (COWS)

  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.

  4-week trial: Peak COWS score throughout the testing session for each dose combination.

Study Arms (6)

Naloxone 0 mg + MJ 0.0 mg

PLACEBO COMPARATOR

Intranasal naloxone in combination with vaped marijuana

Drug: Naloxone; Drug: Marijuana

Naloxone 0 mg + MJ 12.5 mg

ACTIVE COMPARATOR

Intranasal naloxone in combination with vaped marijuana

Drug: Marijuana

Naloxone 0 mg + MJ 25 mg

ACTIVE COMPARATOR

Intranasal naloxone in combination with vaped marijuana (MJ)

Drug: Marijuana

Naloxone 4 mg + MJ 0.0 mg

ACTIVE COMPARATOR

Intranasal naloxone in combination with vaped marijuana (MJ)

Drug: Naloxone

Naloxone 4 mg + MJ 12.5 mg

EXPERIMENTAL

Intranasal naloxone in combination with vaped marijuana (MJ)

Drug: Naloxone; Drug: Marijuana

Naloxone 4 mg + MJ 25 mg

EXPERIMENTAL

Intranasal naloxone in combination with vaped marijuana (MJ)

Drug: Naloxone; Drug: Marijuana

Interventions

Naloxone DRUG

Intranasal Naloxone

Naloxone 0 mg + MJ 0.0 mg; Naloxone 4 mg + MJ 0.0 mg; Naloxone 4 mg + MJ 12.5 mg; Naloxone 4 mg + MJ 25 mg

Marijuana DRUG

Vaped Marijuana

Naloxone 0 mg + MJ 0.0 mg; Naloxone 0 mg + MJ 12.5 mg; Naloxone 0 mg + MJ 25 mg; Naloxone 4 mg + MJ 12.5 mg; Naloxone 4 mg + MJ 25 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age.
• Diagnostic criteria for Opioid Use Disorder (OUD) moderate-severe (304.00) as per DSM-V, including physiological dependence and not currently seeking treatment for OUD.
• Self-reported opioid use for nontherapeutic purposes; and positive urine drug screen for opioids.
• Physically healthy.
• Normal body weight/Within 20% of body weight (for appropriate frame) according to 1983 Metropolitan Weight tables.
• Able to perform study procedures.
• Females must be either:
• Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or
• Women of childbearing potential must agree to use an acceptable double-barrier method of contraception during screening and study participation.
• Must smoke \< three cannabis cigarettes three times a week (or the vaping equivalent) for the four weeks before screening.

You may not qualify if:

• Seeking treatment for Opioid Use Disorder.
• Current or history of a psychiatric condition that would affect participants' ability to provide informed consent (e.g., mood disorder with functional impairment or schizophrenia) or make participant hazardous for the participant (e.g., recent suicidal ideation) or staff (e.g., significant history of violence).
• Current DSM-V diagnosis of substance use disorders requiring medically managed detoxification, other than OUD (e.g., alcohol or benzodiazepine dependence).
• Medical condition resulting in chronic pain (\>3 months).
• Clinically significant abnormality on physical examination, vital signs, screening laboratory tests, or 12- lead ECG.
• Significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic disorder.
• Any surgical, or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the study drugs.
• Baseline hypotension, orthostatic hypotension or syncope, hypertension (blood pressure \> 140/90), pulmonary hypertension or heart disease.
• Any of the following values for laboratory tests:
• positive pregnancy test,
• hemoglobin \< 12 g/dL in males and \< 11 g/dL in females,
• neutrophil count \< 1.0 × 109/L,
• platelet count \< 75 × 109/L,
• creatinine clearance \< 50 ml/min per modified Cockcroft-Gault equation,
• aspartate aminotransferase or alanine aminotransferase \> 3.0 × upper limit of normal.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Jones JD, Martinez S, Arout C, Haney M, Castillo F, Manubay J, Perez F, Luba RR, Comer SD. The effects of vaped cannabis on the severity of naloxone-precipitated opioid withdrawal. Exp Clin Psychopharmacol. 2025 Aug 21:10.1037/pha0000796. doi: 10.1037/pha0000796. Online ahead of print.

  PMID: 40839512 DERIVED

MeSH Terms

Conditions

Opiate Overdose

Interventions

Naloxone; nabiximols

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Jermaine Jones PhD: Research Scientist/Associate Professor
• Organization: New York State Psychiatric Institute

jermaine.jones@nyspi.columbia.edu

646 774-6113

Study Officials

• Jermaine Jones, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 10, 2021
• Study Start: November 1, 2021
• Primary Completion: October 15, 2024
• Study Completion: October 29, 2024
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)