Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    32
  • sponsor
    New York State Psychiatric Institute
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Updated on 8 December 2021
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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.

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. Marijuana plant material will be obtained from the National Institutes on Drug Abuse (NIDA). In clinical studies, oral synthetic THC reduced the severity of opioid withdrawal during opioid detoxification. Clinically, cannabinoid drugs like Marinol (oral synthetic THC), Sativex (nabixomols), and Cesamet (nabilone) are used to treat nausea and vomiting, common symptoms of opioid withdrawal. This study will investigate the ability of vaporized marijuana (V-MJ) (0.00, 12.5, and 25 mg: concentration= 11.7% THC + 0.04% CBD) to reduce the severity of opioid withdrawal precipitated by intranasal (IN) NLX (0.0 and 4.0 mg). This trial will recruit healthy participants with opioid use disorder (N=16, completers). Testing will begin following stabilization on oral morphine (120 mg/day), which will continue throughout the trial. During each testing session, a single V-MJ + naloxone dose combination will be assessed (in randomized order), with 48 hours between testing sessions. Laboratory testing sessions will consist of a modified naloxone challenge procedure, which quantifies the severity of naloxone-precipitated opioid withdrawal.

Details
Condition Opioid Overdose
Treatment naloxone, Marijuana
Clinical Study IdentifierNCT05114460
SponsorNew York State Psychiatric Institute
Last Modified on8 December 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

18-55 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

Exclusion Criteria

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
Hypersensitivity to opioids, history of significant adverse reactions to cannabinoids, and allergy or contraindication to any other drugs administered as a part of this investigation
Use of an investigational agent within 30 days
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