Trial Outcomes & Findings for Opioid and Cannabinoid Interactions (NCT NCT03705559)

Last Updated: 2025-04-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

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.

Results posted on

2025-04-10

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	10
Overall Study Placebo/Placebo	10
Overall Study THC 10mg/Placebo Opioid	9
Overall Study THC 30mg/Placebo Opioid	10
Overall Study Oxycodone 15mg/Placebo Marijuana	9
Overall Study Oxycodone 30mg/Placebo Marijuana	9
Overall Study TCH 10mg/Oxycodone 15mg	9
Overall Study TCH 10mg/Oxycodone 30mg	9
Overall Study TCH 30mg/Oxycodone 15mg	9
Overall Study TCH 30mg/Oxycodone 30mg	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study COVID Shut down	1

Baseline Characteristics

Opioid and Cannabinoid Interactions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Opioid and Cannabinoid Interactions n=9 Participants Within subject study. Participants will receive experimental/non-therapeutic doses of active/inactive marijuana in combination experimental/non-therapeutic dose of inactive/active opioids.
Age, Continuous	39.78 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	4 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Population: Per Protocol population, defined as participants completing the experimental drug conditions.

Outcome measures

Outcome measures
Measure	Placebo/Placebo n=9 Participants Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	THC 10mg/Placebo Opioid n=9 Participants Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	THC 30mg/Placebo Opioid n=9 Participants Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	Oxycodone 15mg/Placebo Marijuana n=9 Participants Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	Oxycodone 30mg/Placebo Marijuana n=9 Participants Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	TCH 10mg/Oxycodone 15mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 10mg/Oxycodone 30mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 30mg/Oxycodone 15mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 30mg/Oxycodone 30mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally
Change in Subject-Rated Outcome - VAS Drug Liking	3 score on a scale Standard Error 1.83	53.33 score on a scale Standard Error 10.03	58.89 score on a scale Standard Error 9.09	38.78 score on a scale Standard Error 8.29	35.22 score on a scale Standard Error 8.54	48.67 score on a scale Standard Error 10.68	48.00 score on a scale Standard Error 8.82	65.22 score on a scale Standard Error 8.02	72.11 score on a scale Standard Error 8.04

SECONDARY outcome

Timeframe: 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.

Population: Per Protocol population, defined as participants completing the experimental drug conditions.

Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores.

Outcome measures

Outcome measures
Measure	Placebo/Placebo n=9 Participants Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	THC 10mg/Placebo Opioid n=9 Participants Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	THC 30mg/Placebo Opioid n=9 Participants Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	Oxycodone 15mg/Placebo Marijuana n=9 Participants Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	Oxycodone 30mg/Placebo Marijuana n=9 Participants Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	TCH 10mg/Oxycodone 15mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 10mg/Oxycodone 30mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 30mg/Oxycodone 15mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 30mg/Oxycodone 30mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally
Change in Oxygen Saturation	96.56 percentage of oxygen saturation Standard Error 0.29	96.44 percentage of oxygen saturation Standard Error 0.18	96.44 percentage of oxygen saturation Standard Error 0.18	96.44 percentage of oxygen saturation Standard Error 0.24	96.11 percentage of oxygen saturation Standard Error 0.11	96.22 percentage of oxygen saturation Standard Error 0.15	96.28 percentage of oxygen saturation Standard Error 0.30	95.83 percentage of oxygen saturation Standard Error 0.31	96.00 percentage of oxygen saturation Standard Error 0.19

SECONDARY outcome

Timeframe: 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.

Population: Per Protocol population, defined as participants completing the experimental drug conditions.

Respiration rate (number of breaths per minute). Raw data transformed to trough scores.

Outcome measures

Outcome measures
Measure	Placebo/Placebo n=9 Participants Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	THC 10mg/Placebo Opioid n=9 Participants Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	THC 30mg/Placebo Opioid n=9 Participants Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	Oxycodone 15mg/Placebo Marijuana n=9 Participants Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	Oxycodone 30mg/Placebo Marijuana n=9 Participants Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	TCH 10mg/Oxycodone 15mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 10mg/Oxycodone 30mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 30mg/Oxycodone 15mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 30mg/Oxycodone 30mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally
Change in Respiration Rate	11.89 number of breaths per minute Standard Error 0.68	11.44 number of breaths per minute Standard Error 0.56	12.44 number of breaths per minute Standard Error 0.85	11.22 number of breaths per minute Standard Error 0.60	10.22 number of breaths per minute Standard Error 0.36	10.89 number of breaths per minute Standard Error 0.35	10.44 number of breaths per minute Standard Error 0.44	10.56 number of breaths per minute Standard Error 0.53	10.89 number of breaths per minute Standard Error 0.42

SECONDARY outcome

Timeframe: 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.

Population: Per Protocol population, defined as participants completing the experimental drug conditions.

Systolic blood pressure (mm Hg). Raw data transformed to peak scores.

Outcome measures

Outcome measures
Measure	Placebo/Placebo n=9 Participants Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	THC 10mg/Placebo Opioid n=9 Participants Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	THC 30mg/Placebo Opioid n=9 Participants Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	Oxycodone 15mg/Placebo Marijuana n=9 Participants Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	Oxycodone 30mg/Placebo Marijuana n=9 Participants Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	TCH 10mg/Oxycodone 15mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 10mg/Oxycodone 30mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 30mg/Oxycodone 15mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally	TCH 30mg/Oxycodone 30mg n=9 Participants Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally
Change in Systolic Blood Pressure	133.56 mm Hg Standard Error 2.18	134.06 mm Hg Standard Error 3.50	140.56 mm Hg Standard Error 3.72	136.33 mm Hg Standard Error 3.98	134.33 mm Hg Standard Error 3.36	138.11 mm Hg Standard Error 2.87	139.39 mm Hg Standard Error 3.27	147.04 mm Hg Standard Error 5.26	147.56 mm Hg Standard Error 4.46

SECONDARY outcome

Population: Per Protocol population, defined as participants completing the experimental drug conditions.

Diastolic blood pressure (mm Hg). Raw data transformed to peak scores.