Opioid Use DisorderPhase 1NCT07668635
Cannabis Effects on Opioid Self-Administration
A Phase 1 study testing Cannabis, Intranasal Opioid Agonist and Oral Opioid Agonist in people with Opioid Use Disorder and Cannabis Use, run by Shanna Babalonis, PhD at 1 site in United States.
Trial summary
The study will enroll participants with opioid use disorder and participants will reside at the University of Kentucky Hospital for this 6-week inpatient trial. During this time, double-blind doses of cannabis and opioids will be administered. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Opioid Use Disorder, Cannabis Use
- What is being tested?
- Cannabis, Intranasal Opioid Agonist and Oral Opioid Agonist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 30 Jul 2031
- 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 experience opioid withdrawal
- No allergies or adverse reactions to cannabis or opioids
- Willing to stay inpatient at the UK Hospital research center for approx. 6 weeks
Who cannot join
- Individuals seeking treatment for opioid use disorder
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 Center on Drug and Alcohol Research
Lexington, Kentucky, 40508
About this study
Official title: Impact of Cannabis on Opioid Self-Administration
The study will enroll participants with opioid use disorder and participants will reside at the University of Kentucky Hospital for this 6-week inpatient trial. During this time, double-blind doses of cannabis and opioids will be administered. The goal of the project is to determine if cannabis can alter the drive/desire to take opioids.
- Conditions
- Opioid Use Disorder, Cannabis Use
- Being tested
- Cannabis, Placebo Cannabis, Intranasal Opioid Agonist, Oral Opioid Agonist
- Keywords
- opioid use, cannabis
- 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.
CannabisDrug
Cannabis is administered three times daily during the active cannabis treatment period.
Placebo CannabisDrug
Matched placebo cannabis is administered three times daily during the placebo treatment period.
Intranasal Opioid AgonistDrug
Intranasal opioid agonists are administered during sample and self-administration sessions
Oral Opioid AgonistDrug
Oral opioid agonist maintenance doses are administered four times daily throughout study participation.
| Study group | Role | What they receive |
|---|---|---|
| Active Cannabis | Experimental | Participants receive active cannabis three times daily for approximately 16 days during one crossover treatment period. During this period, participants complete sample and self-administration sessions evaluating placebo and active intranasal opioid administration. Receives: Drug: Cannabis; Drug: Intranasal Opioid Agonist; Drug: Oral Opioid Agonist |
| Placebo Cannabis | Placebo comparator | Participants receive placebo cannabis three times daily for approximately 16 days during one crossover treatment period. During this period, participants complete sample and self-administration sessions evaluating placebo and active intranasal opioid administration. Receives: Drug: Placebo Cannabis; Drug: Intranasal Opioid Agonist; Drug: Oral Opioid Agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Opioid Self-Administration Trials Completed
Number of drug-choice trials completed for intranasal opioid agonists during self-administration sessions.
Measured: Up to 6.5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Jul 2031 (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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanna Babalonis, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-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
- NCT07668635
- Sponsor's protocol ID
- 106065
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2026
- Last updated
- 14 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cannabis on Opioid Self-Administration
- ClinicalTrials.gov ID
- NCT07668635
- Acronym / sponsor ID
- 106065
- Conditions
- Opioid Use Disorder, Cannabis Use
- Keywords
- opioid use, cannabis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanna Babalonis, PhDUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 25 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.
The study will enroll participants with opioid use disorder and participants will reside at the University of Kentucky Hospital for this 6-week inpatient trial. During this time, double-blind doses of cannabis and opioids will be administered. The goal of the project is to determine if cannabis can alter the drive/desire to take opioids.
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 |
|---|---|---|
| Active Cannabis | Experimental | Drug: Cannabis, Drug: Intranasal Opioid Agonist, Drug: Oral Opioid AgonistParticipants receive active cannabis three times daily for approximately 16 days during one crossover treatment period. During this period, participants complete sample and self-administration sessions evaluating placebo and active intranasal opioid administration. |
| Placebo Cannabis | Placebo comparator | Drug: Placebo Cannabis, Drug: Intranasal Opioid Agonist, Drug: Oral Opioid AgonistParticipants receive placebo cannabis three times daily for approximately 16 days during one crossover treatment period. During this period, participants complete sample and self-administration sessions evaluating placebo and active intranasal opioid administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants with moderate to severe opioid use disorder who experience opioid withdrawal
- No allergies or adverse reactions to cannabis or opioids
- Willing to stay inpatient at the UK Hospital research center for approx. 6 weeks
Key exclusion criteria (1 listed)
- Individuals seeking treatment for opioid use disorder
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 |
|---|---|---|
| CannabisCannabis is administered three times daily during the active cannabis treatment period. | Drug | Active Cannabis |
| Placebo CannabisMatched placebo cannabis is administered three times daily during the placebo treatment period. | Drug | Placebo Cannabis |
| Intranasal Opioid AgonistIntranasal opioid agonists are administered during sample and self-administration sessions | Drug | Active Cannabis, Placebo Cannabis |
| Oral Opioid AgonistOral opioid agonist maintenance doses are administered four times daily throughout study participation. | Drug | Active Cannabis, Placebo Cannabis |
Primary outcome
Number of Opioid Self-Administration Trials Completed
Time frame: Up to 6.5 Weeks
Number of drug-choice trials completed for intranasal opioid agonists during self-administration sessions.
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 14 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 Cannabis, Intranasal Opioid Agonist and Oral Opioid Agonist in people with Opioid Use Disorder and Cannabis 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 3 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 14 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?
Number of Opioid Self-Administration Trials Completed (time frame: Up to 6.5 Weeks). 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 14 Oct 2026.