Opioid OverdosePhase 2NCT05114460

Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal

A Phase 2 study testing Naloxone and Marijuana in people with Opioid Overdose, run by New York State Psychiatric Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Opioid Overdose
What is being tested?: Naloxone and Marijuana
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2021to 29 Oct 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

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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.

Who cannot join

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.

Show all 17Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York State Psychiatric Institute
New York, New York, 10032

Other trials in United States

About this study

Official title: The Ability of Vaped Marijuana to Reduce the Severity of Naloxone-Precipitated Withdrawal

Read the 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.

Conditions: Opioid Overdose
Being tested: Naloxone, Marijuana
Medical subject headings: Opiate Overdose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NaloxoneDrug
Intranasal Naloxone
MarijuanaDrug
Vaped Marijuana

Study groups in NCT05114460
Study group	Role	What they receive
Naloxone 0 mg + MJ 0.0 mg	Placebo comparator	Intranasal naloxone in combination with vaped marijuana Receives: Drug: Naloxone; Drug: Marijuana
Naloxone 0 mg + MJ 12.5 mg	Active comparator	Intranasal naloxone in combination with vaped marijuana Receives: Drug: Marijuana
Naloxone 0 mg + MJ 25 mg	Active comparator	Intranasal naloxone in combination with vaped marijuana (MJ) Receives: Drug: Marijuana
Naloxone 4 mg + MJ 0.0 mg	Active comparator	Intranasal naloxone in combination with vaped marijuana (MJ) Receives: Drug: Naloxone
Naloxone 4 mg + MJ 12.5 mg	Experimental	Intranasal naloxone in combination with vaped marijuana (MJ) Receives: Drug: Naloxone; Drug: Marijuana
Naloxone 4 mg + MJ 25 mg	Experimental	Intranasal naloxone in combination with vaped marijuana (MJ) Receives: Drug: Naloxone; Drug: Marijuana

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202129 Oct 2024

First posted10 Nov 2021
Study start1 Nov 2021
Primary completion15 Oct 2024
Study completion29 Oct 2024

Why it stopped: The U.S. Department of Health and Human Services Office of Human Research Protections issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. Recruitment for this trial will not reopen.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid OverdoseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05114460
Sponsor's protocol ID: 8061
Status last verified: Mar 2025
First submitted: 5 Oct 2021
Last updated: 18 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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. 2026 Jun;34(3):318-323. doi: 10.1037/pha0000796. Epub 2025 Aug 21.
PubMed 40839512

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
Overdose, Implementation as Usual

All Opioid Overdose trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Ability of Vaped Marijuana to Reduce the Severity of Naloxone-Precipitated Withdrawal
ClinicalTrials.gov ID: NCT05114460
Acronym / sponsor ID: 8061
Conditions: Opioid Overdose
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The U.S. Department of Health and Human Services Office of Human Research Protections issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. Recruitment for this trial will not reopen.
Enrolment: 2 participants (actual)
Lead sponsor: New York State Psychiatric InstituteUniversity, hospital or other
Study start: 1 Nov 2021 (actual)
Primary completion: 15 Oct 2024 (actual)
Study completion: 29 Oct 2024 (actual)
First posted: 10 Nov 2021 (actual)
Results: Posted 18 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Naloxone 0 mg + MJ 0.0 mg	Placebo comparator	Drug: Naloxone, Drug: MarijuanaIntranasal naloxone in combination with vaped marijuana
Naloxone 0 mg + MJ 12.5 mg	Active comparator	Drug: MarijuanaIntranasal naloxone in combination with vaped marijuana
Naloxone 0 mg + MJ 25 mg	Active comparator	Drug: MarijuanaIntranasal naloxone in combination with vaped marijuana (MJ)
Naloxone 4 mg + MJ 0.0 mg	Active comparator	Drug: NaloxoneIntranasal naloxone in combination with vaped marijuana (MJ)
Naloxone 4 mg + MJ 12.5 mg	Experimental	Drug: Naloxone, Drug: MarijuanaIntranasal naloxone in combination with vaped marijuana (MJ)
Naloxone 4 mg + MJ 25 mg	Experimental	Drug: Naloxone, Drug: MarijuanaIntranasal naloxone in combination with vaped marijuana (MJ)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NaloxoneIntranasal Naloxone	Drug	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
MarijuanaVaped Marijuana	Drug	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

Primary outcome

Clinical Opiate Withdrawal Scale (COWS)
Time frame: 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.

Results and safety

Results posted to the registry on 18 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	1	1

Primary outcome: Clinical Opiate Withdrawal Scale (COWS)

Time frame: 4-week trial: Peak COWS score throughout the testing session for each dose combination.. Number. Unit: units on a scale

Measure	Naloxone 0 mg + MJ 0.0 mg n = 1	Naloxone 0 mg + MJ 12.5 mg n = 1	Naloxone 0 mg + MJ 25 mg n = 1	Naloxone 4 mg + MJ 0.0 mg n = 1	Naloxone 4 mg + MJ 12.5 mg n = 1	Naloxone 4 mg + MJ 25 mg n = 1
Value	2	2	4	27	21	20

Population analysed: Data are only available from 1 participant and the other participant enrolled did not complete any testing sessions.

Adverse events

Time frame: All Study Participants, the 4-week Inpatient testing period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40839512Jones 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. 2026 Jun;34(3):318-323. doi: 10.1037/pha0000796. Epub 2025 Aug 21.
Individual participant dataSharing planned: No

Related trials for Opioid Overdose

Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
Prevention and Rapid Outreach for Treatment, Engagement, and Care Transition From the Emergency Department
Opioid Overdose Prevention, HIV Prevention and Care
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Active, not recruiting
Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jermaine Jones, PhD principal investigator

New York State Psychiatric Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naloxone and Marijuana in people with Opioid Overdose, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Opiate Withdrawal Scale (COWS) (time frame: 4-week trial: Peak COWS score throughout the testing session for each dose combination.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05114460, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.