Opioid Use DisordersPhase 1NCT07661446
Cannabis and Opioid Use Disorder, Study 2
A Phase 1 study testing Inhaled Cannabis and Intranasal Opioid in people with Opioid Use Disorders and Cannabis Use, run by University of Kentucky at 1 site in United States.
Trial summary
This inpatient study enrolls healthy individuals who have opioid use disorder. Participants live at the University of Kentucky Hospital for approx. 6 weeks. During this time, we will examine how repeated doses of oral cannabis and acute doses of oral and inhaled cannabis 1) modify the intensity and time course of… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Opioid Use Disorders, Cannabis Use
- What is being tested?
- Inhaled Cannabis and Intranasal Opioid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 30 Jan 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with moderate to severe opioid use disorder
Who cannot join
- Individuals who do not use opioids or do not experience opioid withdrawal when they stop using opioids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kentucky
Lexington, Kentucky, 40508
Paul Nuzzo, 859-323-0002, paul.nuzzo@uky.edu
Shanna Babalonis, PhD
About this study
This inpatient study enrolls healthy individuals who have opioid use disorder. Participants live at the University of Kentucky Hospital for approx. 6 weeks. During this time, we will examine how repeated doses of oral cannabis and acute doses of oral and inhaled cannabis 1) modify the intensity and time course of opioid withdrawal, 2) modify the effects of intranasal opioid administration and 3) impact the safety of opioid administration.
- Conditions
- Opioid Use Disorders, Cannabis Use
- Being tested
- Inhaled Cannabis, Intranasal Opioid
- Keywords
- Cannabis, marijuana, opioid, opioid use disorder, opioid withdrawal, opioid interaction
- Medical subject headings
- Opioid-Related Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled CannabisDrug
Participants will receive inhaled cannabis and placebo
Intranasal OpioidDrug
Participants will receive intranasal opioids and placebo
| Study group | Role | What they receive |
|---|---|---|
| Oral cannabis (placebo) | Placebo comparator | Participants will receive placebo oral cannnabis Receives: Drug: Inhaled Cannabis; Drug: Intranasal Opioid |
| Oral cannabis (active) | Experimental | Participants will receive active oral cannabis Receives: Drug: Inhaled Cannabis; Drug: Intranasal Opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid withdrawal severity
Opioid severity is a participant-rated outcome that will be measured on a visual analog scale (0-100)
Measured: This outcome will be assessed regularly from baseline through 6 hours post cannabis dose during experimental sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisordersStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanna Babalonis, PhD, University of Kentucky
- Investigators
- Shanna Babalonis, PhD, Principal investigator, University of Kentucky College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661446
- Sponsor's protocol ID
- 75562-20263
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis and Opioid Use Disorder, Study 2
- ClinicalTrials.gov ID
- NCT07661446
- Acronym / sponsor ID
- 75562-20263
- Conditions
- Opioid Use Disorders, Cannabis Use
- Keywords
- Cannabis, marijuana, opioid, opioid use disorder, opioid withdrawal, opioid interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This inpatient study enrolls healthy individuals who have opioid use disorder. Participants live at the University of Kentucky Hospital for approx. 6 weeks. During this time, we will examine how repeated doses of oral cannabis and acute doses of oral and inhaled cannabis 1) modify the intensity and time course of opioid withdrawal, 2) modify the effects of intranasal opioid administration and 3) impact the safety of opioid administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral cannabis (placebo) | Placebo comparator | Drug: Inhaled Cannabis, Drug: Intranasal OpioidParticipants will receive placebo oral cannnabis |
| Oral cannabis (active) | Experimental | Drug: Inhaled Cannabis, Drug: Intranasal OpioidParticipants will receive active oral cannabis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants with moderate to severe opioid use disorder
Key exclusion criteria (1 listed)
- Individuals who do not use opioids or do not experience opioid withdrawal when they stop using opioids
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 |
|---|---|---|
| Inhaled CannabisParticipants will receive inhaled cannabis and placebo | Drug | Oral cannabis (active), Oral cannabis (placebo) |
| Intranasal OpioidParticipants will receive intranasal opioids and placebo | Drug | Oral cannabis (active), Oral cannabis (placebo) |
Primary outcome
Opioid withdrawal severity
Time frame: This outcome will be assessed regularly from baseline through 6 hours post cannabis dose during experimental sessions.
Opioid severity is a participant-rated outcome that will be measured on a visual analog scale (0-100)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Shanna Babalonis, PhD principal investigator
University of Kentucky College of Medicine
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 Inhaled Cannabis and Intranasal Opioid in people with Opioid Use Disorders and Cannabis Use, run by University of Kentucky 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 1 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: opening soon, as of the sponsor's last update on 9 Oct 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Nuzzo (859-323-0002, paul.nuzzo@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid withdrawal severity (time frame: This outcome will be assessed regularly from baseline through 6 hours post cannabis dose during experimental sessions.). 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 9 Oct 2026.