Marijuana UsePhase 1NCT05485012
Reinforcing Effects of Marijuana and Opioids
A Phase 1 study testing Marijuana and Opioid in people with Marijuana Use and Opioid Use, run by Shanna Babalonis, PhD at 1 site in United States.
Trial summary
The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Use, Opioid Use
- What is being tested?
- Marijuana and Opioid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2023to 27 Mar 2025
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-50
- Experience with marijuana and opioids
- General good health
- Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided,
Who cannot join
- Significant medical complications/conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration
The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.
- Conditions
- Marijuana Use, Opioid Use
- Being tested
- Marijuana, Opioid
- Keywords
- marijuana, opioid, healthy participants, laboratory study
- Medical subject headings
- Marijuana Use, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarijuanaDrug
Also called Cannabis
Double-blind administration of marijuana
OpioidDrug
Double-blind administration of an opioid agonist
| Study group | Role | What they receive |
|---|---|---|
| Double-blind marijuana/placebo administration | Experimental | Participants will receive double-blind administration of vaporized marijuana/placebo Receives: Drug: Marijuana; Drug: Opioid |
| Double-blind opioid/placebo administration | Experimental | Participants will receive double-blind administration of intranasal opioid agonist/placebo Receives: Drug: Marijuana; Drug: Opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Administration of Drug Units Earned
The number of units of drug (out of a total of 7) earned in each experimental condition. Participants work for some, none, or all of the available drug dose. For each dose condition, the number of drug units completed for drug was pulled from the raw data and averaged to yield one mean (SEM).
Measured: Through a progressive-ratio self-administration model given once per treatment condition throughout each 6 hour session
Secondary outcomes (2)
Peak End-tidal Carbon Dioxide (EtCO2)
End-tidal Carbon Dioxide (EtCO2): For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). Higher scores indicate greater impairment.
Measured: This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).
Trough Respiration Rate
Respiration rate (number of breaths per minute): For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM). Lower scores indicate greater impairment.
Measured: This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start3 Aug 2023
- Primary completion27 Mar 2025
- Study completion27 Mar 2025
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 UseStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanna Babalonis, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Shanna Babalonis, PhD, University of Kentucky
- Investigators
- Shanna Babalonis, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485012
- Sponsor's protocol ID
- 45017-20221
- Other IDs
- R01DA045700
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2022
- Last updated
- 15 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration
- ClinicalTrials.gov ID
- NCT05485012
- Acronym / sponsor ID
- 45017-20221
- Conditions
- Marijuana Use, Opioid Use
- Keywords
- marijuana, opioid, healthy participants, laboratory study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shanna Babalonis, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Posted 15 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-blind marijuana/placebo administration | Experimental | Drug: Marijuana, Drug: OpioidParticipants will receive double-blind administration of vaporized marijuana/placebo |
| Double-blind opioid/placebo administration | Experimental | Drug: Marijuana, Drug: OpioidParticipants will receive double-blind administration of intranasal opioid agonist/placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18-50
- Experience with marijuana and opioids
- General good health
- Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided,
Key exclusion criteria (1 listed)
- Significant medical complications/conditions
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 |
|---|---|---|
| MarijuanaAlso: CannabisDouble-blind administration of marijuana | Drug | Double-blind marijuana/placebo administration, Double-blind opioid/placebo administration |
| OpioidDouble-blind administration of an opioid agonist | Drug | Double-blind marijuana/placebo administration, Double-blind opioid/placebo administration |
Primary outcome
Self-Administration of Drug Units Earned
Time frame: Through a progressive-ratio self-administration model given once per treatment condition throughout each 6 hour session
The number of units of drug (out of a total of 7) earned in each experimental condition. Participants work for some, none, or all of the available drug dose. For each dose condition, the number of drug units completed for drug was pulled from the raw data and averaged to yield one mean (SEM).
2 secondary outcomes
Peak End-tidal Carbon Dioxide (EtCO2)
Time frame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).
Trough Respiration Rate
Time frame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Marijuana Use
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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 Marijuana and Opioid in people with Marijuana Use 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 4 inclusion and 1 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 15 Apr 2026. 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. 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 15 Apr 2026). 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?
Self-Administration of Drug Units Earned (time frame: Through a progressive-ratio self-administration model given once per treatment condition throughout each 6 hour session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.