Opioid Use DisorderPhase 1NCT05729932
Cannabis and Opioid Use Disorder
A Phase 1 study testing Inhaled vaporized cannabis and Intransal opioid in people with Opioid Use Disorder, run by Shanna Babalonis, PhD at 1 site in United States.
Trial summary
This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Inhaled vaporized cannabis and Intransal opioid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 30 Jun 2027
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current opioid use disorder
Who cannot join
- Current medical conditions that require medical management
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, 1 recruiting
- Recruiting
Center on Drug and Alcohol Research
Lexington, Kentucky, 40508
Paul Nuzzo, MA, 859-323-0002, pnuzz2@email.uky.edu
About this study
Official title: Cannabis Modulation of Outcomes Related to Opioid Use Disorder: Opioid Withdrawal, Abuse Potential and Safety
This study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.
- Conditions
- Opioid Use Disorder
- Being tested
- Inhaled vaporized cannabis, Intransal opioid
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled vaporized cannabisDrug
Double-blind cannabis and placebo doses, administered through vaporizer
Intransal opioidDrug
Double-blind opioid and placebo doses, administered intranasal route
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Opioid Agonist | Experimental | Participants will receive non-therapeutic, experimental doses of an opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intransally (snorting). Receives: Drug: Inhaled vaporized cannabis; Drug: Intransal opioid |
| Vaporized cannabis | Experimental | Participants will receive non-therapeutic, experimental doses of active or placebo vaporized cannabis. Active cannabis/placebo will be administered once per session and will be administered via a vaporizer. Receives: Drug: Inhaled vaporized cannabis; Drug: Intransal opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)
Subjective ratings of opioid withdrawal severity on visual analog scale (scale 0-100; 0 = not at all, 100 = extremely)
Measured: Change from baseline
Secondary outcomes (2)
Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS)
Subjective ratings of drug liking on visual analog scale (scale 0-100, 0 = not at all, 100 = extremely)
Measured: Change from baseline
Change from Baseline - Respiration
Physiological monitoring of respiration rate (breaths per minute)
Measured: Change from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start10 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies 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
- 15 participants (estimated)
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
- NCT05729932
- Sponsor's protocol ID
- 75562-20242
- Other IDs
- 1R01DA054347
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Modulation of Outcomes Related to Opioid Use Disorder: Opioid Withdrawal, Abuse Potential and Safety
- ClinicalTrials.gov ID
- NCT05729932
- Acronym / sponsor ID
- 75562-20242
- Conditions
- Opioid Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanna Babalonis, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Feb 2023 (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 study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.
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 |
|---|---|---|
| Intranasal Opioid Agonist | Experimental | Drug: Inhaled vaporized cannabis, Drug: Intransal opioidParticipants will receive non-therapeutic, experimental doses of an opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered intransally (snorting). |
| Vaporized cannabis | Experimental | Drug: Inhaled vaporized cannabis, Drug: Intransal opioidParticipants will receive non-therapeutic, experimental doses of active or placebo vaporized cannabis. Active cannabis/placebo will be administered once per session and will be administered via a vaporizer. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Current opioid use disorder
Key exclusion criteria (1 listed)
- Current medical conditions that require medical management
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 vaporized cannabisDouble-blind cannabis and placebo doses, administered through vaporizer | Drug | Intranasal Opioid Agonist, Vaporized cannabis |
| Intransal opioidDouble-blind opioid and placebo doses, administered intranasal route | Drug | Intranasal Opioid Agonist, Vaporized cannabis |
Primary outcome
Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS)
Time frame: Change from baseline
Subjective ratings of opioid withdrawal severity on visual analog scale (scale 0-100; 0 = not at all, 100 = extremely)
2 secondary outcomes
Change from Baseline - Opioid Drug Liking - Visual Analog Scale (VAS)
Time frame: Change from baseline
Change from Baseline - Respiration
Time frame: Change from baseline
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 18 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Opioid Use Disorder
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder
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
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 vaporized cannabis and Intransal opioid in people with Opioid Use Disorder, 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 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: looking for participants now, as of the sponsor's last update on 18 Jun 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?
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, MA (859-323-0002, pnuzz2@email.uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline - Opioid Withdrawal Severity - Visual Analog Scale (VAS) (time frame: Change from baseline). 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 18 Jun 2026.