Opioid and Cannabinoid Interactions

Interactions of Marijuana and Opioids: Pharmacodynamic Effects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03705559

Enrollment

Registered

2018-10-15

Start date

2019-06-21

Completion date

2024-02-15

Last updated

2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marijuana Usage, Opioid Use

Keywords

marijuana, opioid, opiate, cannabis

Brief summary

This study will examine the effects of doses of marijuana/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

Interventions

DRUGVaporized Marijuana

Active Marijuana administered through vaporizer

DRUGOpioid Agonist

Active Opioid Agonist administered intranasally

DRUGPlacebo

Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Masking description

This is a randomized, double-blind, double-dummy, placebo-controlled design

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Healthy adults ages 18-50 * Current non-medical use of opioids and marijuana

Exclusion criteria

* Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics * Seeking treatment for drug use * Significant medical problems

Design outcomes

Primary

Measure	Time frame	Description
Change in Subject-Rated Outcome - VAS Drug Liking	This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.	Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.

Secondary

Measure	Time frame	Description
Change in Oxygen Saturation	Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.	Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores.
Change in Respiration Rate	Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.	Respiration rate (number of breaths per minute). Raw data transformed to trough scores.
Change in Systolic Blood Pressure	Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.	Systolic blood pressure (mm Hg). Raw data transformed to peak scores.
Change in Diastolic Blood Pressure	Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.	Diastolic blood pressure (mm Hg). Raw data transformed to peak scores.

Countries

United States

Participant flow

Pre-assignment details

Unique, randomized dose orders were created for each participant. The study utilized a within-subject design.

Participants by arm

Arm	Count
Opioid and Cannabinoid Interactions Within subject study. Participants will receive experimental/non-therapeutic doses of active/inactive marijuana in combination experimental/non-therapeutic dose of inactive/active opioids.	9
Total	9

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	COVID Shut down	1

Baseline characteristics

Characteristic	Opioid and Cannabinoid Interactions
Age, Continuous	39.78 years STANDARD_DEVIATION 9.2
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	4 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	4 Participants
Region of Enrollment United States	9 participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk
deaths Total, all-cause mortality	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9
other Total, other adverse events	4 / 9	0 / 9	1 / 9	2 / 9	2 / 9	0 / 9	3 / 9	2 / 9	0 / 9
serious Total, serious adverse events	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9

Outcome results

Primary

Change in Subject-Rated Outcome - VAS Drug Liking

Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.

Time frame: This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.