NCT07661446 Dronabinol Opioid-Related Disorders Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07661446 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 4 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07661446 is a hot trial to watch
Opioid-Related Disorders is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07661446 is notable because it evaluates Dronabinol in a Phase 1 design sponsored by University of Kentucky. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07661446 |
| Official title | Cannabis and Opioid Use Disorder, Study 2 |
| Phase / status | Phase 1 / Not yet recruiting |
| Intervention | Dronabinol |
| Sponsor | University of Kentucky |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Opioid withdrawal severity |
| Endpoint time frame | This outcome will be assessed regularly from baseline through 6 hours post cannabis dose during experimental sessions. |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
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.
Allocation is Randomized, masking is Triple, and the intervention model is Crossover Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Opioid withdrawal severity (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)
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Dronabinol is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: University of Kentucky is resolved to a normalized organization record in FAYETTE COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07661446 provides a focused lens on Opioid-Related Disorders development. Its value will be determined by whether Dronabinol can convert the current Phase 1 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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