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Marijuana for Opioid Overdose

Phase 2
Waitlist Available
Led By Jermaine Jones, PhD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-weeks trial
Awards & highlights

Study Summary

This trial will test the combined effects of marijuana and NLX as a possible treatment for overdose.

Eligible Conditions
  • Opioid Overdose

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-weeks trial
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-weeks trial for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Opiate Withdrawal Scale (COWS)

Side effects data

From 2021 Phase 1 & 2 trial • 15 Patients • NCT03253926
40%
Gastrointestinal upset
20%
Headache
13%
Trouble sleeping
13%
Eye dryness/discomfort
7%
Anxiety/Jittery
7%
Body pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lorcaserin + Marijuana
Placebo + Marijuana

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Naloxone 4 mg + MJ 25 mgExperimental Treatment2 Interventions
Intranasal naloxone in combination with vaped marijuana (MJ)
Group II: Naloxone 4 mg + MJ 12.5 mgExperimental Treatment2 Interventions
Intranasal naloxone in combination with vaped marijuana (MJ)
Group III: Naloxone 0 mg + MJ 12.5 mgActive Control1 Intervention
Intranasal naloxone in combination with vaped marijuana
Group IV: Naloxone 0 mg + MJ 25 mgActive Control1 Intervention
Intranasal naloxone in combination with vaped marijuana (MJ)
Group V: Naloxone 4 mg + MJ 0.0 mgActive Control1 Intervention
Intranasal naloxone in combination with vaped marijuana (MJ)
Group VI: Naloxone 0 mg + MJ 0.0 mgPlacebo Group2 Interventions
Intranasal naloxone in combination with vaped marijuana
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone
2014
Completed Phase 3
~1240
Marijuana
2008
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,875 Total Patients Enrolled
2 Trials studying Opioid Overdose
501 Patients Enrolled for Opioid Overdose
Jermaine Jones, PhDPrincipal InvestigatorNew York State Psychiatric Institute
1 Previous Clinical Trials
18 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks and benefits should be considered when using cannabis medicinally?

"In view of the available data, our team at Power estimates that marijuana is moderately safe and assigned it a score of 2. This Phase 2 trial has established some safety evidence but cannot yet confirm efficacy."

Answered by AI

What is the total enrollment size for this experiment?

"Affirmative. According to the clinicaltrials.gov platform, this medical trial is actively looking for volunteers after first being posted on November 1st 2021 and edited lastly on December 1st 2021. 32 patients are expected to be recruited from a single facility."

Answered by AI

Is the minimum age requirement for this experiment eighteen or greater?

"This medical investigation is only accepting individuals aged between 18 and 55 years."

Answered by AI

Is it possible for me to become part of this research endeavor?

"This experiment is searching for 32 individuals who have experienced an opiate overdose, aged between 18 and 55. Aspiring participants must meet the following criteria: smoking three or fewer cannabis cigarettes (or its vaping equivalent) in the four weeks prior to screening; a body weight within 20% of what's expected according to 1983 Metropolitan Weight tables; physical healthiness; self-reported opioid use that isn't medically prescribed; and having a positive urine drug screen for opioids. Furthermore, they should be able to endure the trial's procedures adequately."

Answered by AI

Is this research study accepting new participants at present?

"Data hosted on clinicaltrials.gov indicates that this medical trial is actively seeking patients with the last update being posted on December 1st 2021 since its original posting in November of the same year."

Answered by AI

Could you provide information on any prior studies that have analyzed the effects of Cannabis?

"Presently, there are 67 studies into Cannabis with 12 trials in their final phase. Providence, Rhode island is one of the key locations hosting these medical investigations but other centres across 163 cities are also collecting research data."

Answered by AI

In what cases are physicians prescribing Cannabis?

"Cannabis is a viable solution for managing pain, opioid consumption, and pruritus."

Answered by AI

Who else is applying?

What state do they live in?
New York
Alabama
How old are they?
18 - 65
What site did they apply to?
New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal
Jermaine D. Jones 2021. "Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05114460.
~5 spots leftby Sep 2024
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