Trial Outcomes & Findings for Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal (NCT NCT05114460)
NCT ID: NCT05114460
Last Updated: 2025-03-18
Results Overview
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.
TERMINATED
PHASE2
2 participants
4-week trial: Peak COWS score throughout the testing session for each dose combination.
2025-03-18
Participant Flow
2 participants were enrolled however, 1 participant withdrew from the study prior to completing any of the testing sessions (i.e., periods).
After enrollment/admission and prior to testing participants were transition from illicit opioids onto a stable daily dose of a prescription opioid.
Participant milestones
| Measure |
All Participants
Randomized, Within-Subjects Design
|
|---|---|
|
Naloxone 0 mg + Marijuana 0.0 mg
STARTED
|
1
|
|
Naloxone 0 mg + Marijuana 0.0 mg
COMPLETED
|
1
|
|
Naloxone 0 mg + Marijuana 0.0 mg
NOT COMPLETED
|
0
|
|
Naloxone 0 mg + Marijuana 12.5 mg
STARTED
|
1
|
|
Naloxone 0 mg + Marijuana 12.5 mg
COMPLETED
|
1
|
|
Naloxone 0 mg + Marijuana 12.5 mg
NOT COMPLETED
|
0
|
|
Naloxone 0 mg + Marijuana 25 mg
STARTED
|
1
|
|
Naloxone 0 mg + Marijuana 25 mg
COMPLETED
|
1
|
|
Naloxone 0 mg + Marijuana 25 mg
NOT COMPLETED
|
0
|
|
Naloxone 4 mg + Marijuana 0.0 mg
STARTED
|
1
|
|
Naloxone 4 mg + Marijuana 0.0 mg
COMPLETED
|
1
|
|
Naloxone 4 mg + Marijuana 0.0 mg
NOT COMPLETED
|
0
|
|
Naloxone 4 mg + Marijuana 12.5 mg
STARTED
|
1
|
|
Naloxone 4 mg + Marijuana 12.5 mg
COMPLETED
|
1
|
|
Naloxone 4 mg + Marijuana 12.5 mg
NOT COMPLETED
|
0
|
|
Naloxone 4 mg + Marijuana 25 mg
STARTED
|
1
|
|
Naloxone 4 mg + Marijuana 25 mg
COMPLETED
|
1
|
|
Naloxone 4 mg + Marijuana 25 mg
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal
Baseline characteristics by cohort
| Measure |
All Study Participants
n=2 Participants
Two participants were enrolled in the within-subjects trial.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4-week trial: Peak COWS score throughout the testing session for each dose combination.Population: Data are only available from 1 participant and the other participant enrolled did not complete any testing sessions.
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.
Outcome measures
| Measure |
Naloxone 0 mg + MJ 0.0 mg
n=1 Participants
Intranasal naloxone in combination with vaped marijuana
Naloxone: Intranasal Naloxone
Marijuana: Vaped Marijuana
|
Naloxone 0 mg + MJ 12.5 mg
n=1 Participants
Intranasal naloxone in combination with vaped marijuana
Marijuana: Vaped Marijuana
|
Naloxone 0 mg + MJ 25 mg
n=1 Participants
Intranasal naloxone in combination with vaped marijuana (MJ)
Marijuana: Vaped Marijuana
|
Naloxone 4 mg + MJ 0.0 mg
n=1 Participants
Intranasal naloxone in combination with vaped marijuana (MJ)
Naloxone: Intranasal Naloxone
|
Naloxone 4 mg + MJ 12.5 mg
n=1 Participants
Intranasal naloxone in combination with vaped marijuana (MJ)
Naloxone: Intranasal Naloxone
Marijuana: Vaped Marijuana
|
Naloxone 4 mg + MJ 25 mg
n=1 Participants
Intranasal naloxone in combination with vaped marijuana (MJ)
Naloxone: Intranasal Naloxone
Marijuana: Vaped Marijuana
|
|---|---|---|---|---|---|---|
|
Clinical Opiate Withdrawal Scale (COWS)
|
2 units on a scale
|
2 units on a scale
|
4 units on a scale
|
27 units on a scale
|
21 units on a scale
|
20 units on a scale
|
Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jermaine Jones PhD: Research Scientist/Associate Professor
New York State Psychiatric Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place