Marijuana UsagePhase 1NCT03705559

Opioid and Cannabinoid Interactions

A Phase 1 study testing Vaporized Marijuana and Opioid Agonist in people with Marijuana Usage and Opioid Use, run by Shanna Babalonis, PhD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Marijuana Usage, Opioid Use
What is being tested?: Vaporized Marijuana and Opioid Agonist
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 21 Jun 2019to 15 Feb 2024
Phase: Phase 1
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kentucky
Lexington, Kentucky, 40508

Other trials in United States

About this study

Official title: Interactions of Marijuana and Opioids: Pharmacodynamic Effects

Conditions: Marijuana Usage, Opioid Use
Being tested: Vaporized Marijuana, Opioid Agonist, Placebo
Keywords: marijuana, opioid, opiate, cannabis
Medical subject headings: Marijuana Abuse

What participants receive

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

Vaporized MarijuanaDrug
Also called Cannabis, THC
Active Marijuana administered through vaporizer
Opioid AgonistDrug
Also called Oxycodone
Active Opioid Agonist administered intranasally
PlaceboDrug
Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)

Study groups in NCT03705559
Study group	Role	What they receive
Vaporized Marijuana	Experimental	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. Receives: Drug: Vaporized Marijuana; Drug: Placebo
Opioid Agonist	Experimental	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). Receives: Drug: Opioid Agonist; Drug: Placebo
Opioid Agonist/Marijuana Combination	Experimental	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. Receives: Drug: Vaporized Marijuana; Drug: Opioid Agonist
Placebo	Placebo comparator	Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Receives: Drug: Placebo

What is being measured

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

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.
Measured: 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.

Secondary outcomes (4)

Change in Oxygen Saturation
Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores.
Measured: 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.
Change in Respiration Rate
Respiration rate (number of breaths per minute). Raw data transformed to trough scores.
Measured: 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.
Change in Systolic Blood Pressure
Systolic blood pressure (mm Hg). Raw data transformed to peak scores.
Measured: 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.
Change in Diastolic Blood Pressure
Diastolic blood pressure (mm Hg). Raw data transformed to peak scores.
Measured: 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.

Timeline

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

21 Jun 201915 Feb 2024

First posted15 Oct 2018
Study start21 Jun 2019
Primary completion15 Feb 2024
Study completion15 Feb 2024

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.
Other trials for Marijuana UsageStudies 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03705559
Sponsor's protocol ID: 45017
Other IDs: R01DA045700
Status last verified: Mar 2025
First submitted: 3 Oct 2018
Last updated: 10 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: We have no plans to share individual participant data with other researchers.

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

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All Marijuana Usage trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interactions of Marijuana and Opioids: Pharmacodynamic Effects
ClinicalTrials.gov ID: NCT03705559
Acronym / sponsor ID: 45017
Conditions: Marijuana Usage, Opioid Use
Keywords: marijuana, opioid, opiate, cannabis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Shanna Babalonis, PhDUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 21 Jun 2019 (actual)
Primary completion: 15 Feb 2024 (actual)
Study completion: 15 Feb 2024 (actual)
First posted: 15 Oct 2018 (actual)
Results: Posted 10 Apr 2025

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Vaporized Marijuana	Experimental	Drug: Vaporized Marijuana, Drug: PlaceboParticipants 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.
Opioid Agonist	Experimental	Drug: Opioid Agonist, Drug: PlaceboParticipants 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/Marijuana Combination	Experimental	Drug: Vaporized Marijuana, Drug: Opioid AgonistParticipants 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.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

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
Vaporized MarijuanaAlso: Cannabis, THCActive Marijuana administered through vaporizer	Drug	Opioid Agonist/Marijuana Combination, Vaporized Marijuana
Opioid AgonistAlso: OxycodoneActive Opioid Agonist administered intranasally	Drug	Opioid Agonist, Opioid Agonist/Marijuana Combination
PlaceboExperimental, non-therapeutic administration of inactive opioid or marijuana dose(s)	Drug	Opioid Agonist, Placebo, Vaporized Marijuana

Primary outcome

Change in Subject-Rated Outcome - VAS Drug Liking
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.
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.

4 secondary outcomes

Change in Oxygen Saturation
Time frame: 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.
Change in Respiration Rate
Time frame: 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.
Change in Systolic Blood Pressure
Time frame: 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.
Change in Diastolic Blood Pressure
Time frame: 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.

Results and safety

Results posted to the registry on 10 Apr 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
Opioid and Cannabinoid Interactions	10	9

Primary outcome: Change in Subject-Rated Outcome - VAS Drug Liking

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.. Mean (Standard Error). Unit: score on a scale

Measure	Placebo/Placebo n = 9	THC 10mg/Placebo Opioid n = 9	THC 30mg/Placebo Opioid n = 9	Oxycodone 15mg/Placebo Marijuana n = 9	Oxycodone 30mg/Placebo Marijuana n = 9	TCH 10mg/Oxycodone 15mg n = 9	TCH 10mg/Oxycodone 30mg n = 9	TCH 30mg/Oxycodone 15mg n = 9	TCH 30mg/Oxycodone 30mg n = 9
Value	3 (1.83)	53.33 (10.03)	58.89 (9.09)	38.78 (8.29)	35.22 (8.54)	48.67 (10.68)	48.00 (8.82)	65.22 (8.02)	72.11 (8.04)

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

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo/Placebo	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9
THC 10mg/Placebo Opioid	0 of 9 (0%)	0 of 9 (0%)	0 of 9
THC 30mg/Placebo Opioid	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9
Oxycodone 15mg/Placebo Marijuana	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Oxycodone 30mg/Placebo Marijuana	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
TCH 10mg/Oxycodone 15mg	0 of 9 (0%)	0 of 9 (0%)	0 of 9
TCH 10mg/Oxycodone 30mg	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
TCH 30mg/Oxycodone 15mg	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
TCH 30mg/Oxycodone 30mg	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. We have no plans to share individual participant data with other researchers.

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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.

Shanna Babalonis, PhD principal investigator

University of Kentucky

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vaporized Marijuana and Opioid Agonist in people with Marijuana Usage and Opioid Use, run by Shanna Babalonis, PhD 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 10 Apr 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 10 Apr 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?

Change in Subject-Rated Outcome - VAS Drug Liking (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.). 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 NCT03705559.

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 10 Apr 2025.