We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05114460
Recruitment Status : Recruiting
First Posted : November 10, 2021
Last Update Posted : December 2, 2021
Sponsor:
Information provided by (Responsible Party):
Jermaine Jones, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Opioid Overdose Drug: Naloxone Drug: Marijuana Phase 2

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Ability of Vaped Marijuana to Reduce the Severity of Naloxone-Precipitated Withdrawal
Actual Study Start Date : November 1, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Placebo Comparator: Naloxone 0 mg + MJ 0.0 mg
Intranasal naloxone in combination with vaped marijuana
Drug: Naloxone
Intranasal Naloxone

Drug: Marijuana
Vaped Marijuana

Active Comparator: Naloxone 0 mg + MJ 12.5 mg
Intranasal naloxone in combination with vaped marijuana
Drug: Marijuana
Vaped Marijuana

Active Comparator: Naloxone 0 mg + MJ 25 mg
Intranasal naloxone in combination with vaped marijuana (MJ)
Drug: Marijuana
Vaped Marijuana

Active Comparator: Naloxone 4 mg + MJ 0.0 mg
Intranasal naloxone in combination with vaped marijuana (MJ)
Drug: Naloxone
Intranasal Naloxone

Experimental: Naloxone 4 mg + MJ 12.5 mg
Intranasal naloxone in combination with vaped marijuana (MJ)
Drug: Naloxone
Intranasal Naloxone

Drug: Marijuana
Vaped Marijuana

Experimental: Naloxone 4 mg + MJ 25 mg
Intranasal naloxone in combination with vaped marijuana (MJ)
Drug: Naloxone
Intranasal Naloxone

Drug: Marijuana
Vaped Marijuana




Primary Outcome Measures :
  1. Clinical Opiate Withdrawal Scale (COWS) [ Time Frame: 4-weeks trial ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18-55 years of age.
  2. 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.
  3. Self-reported opioid use for nontherapeutic purposes; and positive urine drug screen for opioids.
  4. Physically healthy.
  5. Normal body weight/Within 20% of body weight (for appropriate frame) according to 1983 Metropolitan Weight tables.
  6. Able to perform study procedures.
  7. Females must be either:

    1. Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or
    2. Women of childbearing potential must agree to use an acceptable double-barrier method of contraception during screening and study participation.
  8. Must smoke < three cannabis cigarettes three times a week (or the vaping equivalent) for the four weeks before screening.

Exclusion Criteria:

  1. Seeking treatment for Opioid Use Disorder.
  2. 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).
  3. Current DSM-V diagnosis of substance use disorders requiring medically managed detoxification, other than OUD (e.g., alcohol or benzodiazepine dependence).
  4. Medical condition resulting in chronic pain (>3 months).
  5. Clinically significant abnormality on physical examination, vital signs, screening laboratory tests, or 12- lead ECG.
  6. Significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, or neurologic disorder.
  7. Any surgical, or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the study drugs.
  8. Baseline hypotension, orthostatic hypotension or syncope, hypertension (blood pressure > 140/90), pulmonary hypertension or heart disease.
  9. Any of the following values for laboratory tests:

    1. positive pregnancy test,
    2. hemoglobin < 12 g/dL in males and < 11 g/dL in females,
    3. neutrophil count < 1.0 × 109/L,
    4. platelet count < 75 × 109/L,
    5. creatinine clearance < 50 ml/min per modified Cockcroft-Gault equation,
    6. aspartate aminotransferase or alanine aminotransferase > 3.0 × upper limit of normal.
  10. 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.
  11. Use of an investigational agent within 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05114460


Contacts
Layout table for location contacts
Contact: Freyon Perez, BA 646 774-6182 freymon.perez@nyspi.columbia.edu

Locations
Layout table for location information
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Jermaine Jones, PhD    646-774-6113    jermaine.jones@nyspi.columbia.edu   
Principal Investigator: Jermaine Jones, PhD         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Layout table for investigator information
Principal Investigator: Jermaine Jones, PhD New York State Psychiatric Institute
Layout table for additonal information
Responsible Party: Jermaine Jones, Principal Investigator, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT05114460    
Other Study ID Numbers: 8061
First Posted: November 10, 2021    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Opiate Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drug Overdose
Opioid-Related Disorders
Narcotic-Related Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents