CannabisPhase 1THC-ETOH-IIINCT02710331
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III
A Phase 1 study testing Active Dronabinol and Active Ethanol in people with Cannabis and Alcohol Effect, run by Yale University at 1 site in United States.
Trial summary
The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis, Alcohol Effect, Driving Under the Influence of Alcohol and Other Drugs
- What is being tested?
- Active Dronabinol and Active Ethanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2026
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females 21 to 55 years of age (extremes included).
- Exposed to cannabis at least once.
- Exposed to alcohol at least once.
- Able to provide informed consent.
Who cannot join
- Cannabis naïve
- Alcohol naïve
- Positive pregnancy screen
- Hearing deficits
- Sesame oil allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Biological Studies Unit, VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.
Read the detailed description
To study the effects of ethanol clamped at BAC 0.04% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) on driving.
- Being tested
- Active Dronabinol, Placebo, Active Ethanol
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active DronabinolDrug
10 mg capsule of Dronabinol will be administered orally.
PlaceboDrug
Control: no alcohol, administered for ~80 minutes.
PlaceboDrug
Control: Placebo pill (no active cannabinoids) administered orally.
Active EthanolDrug
Target BrAC of 0.04% reached over 20 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 2 drinks over 1 hour. Administered over a total of 80 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Active THC and Placebo Ethanol | Experimental | Not described Receives: Drug: Active Dronabinol; Drug: Placebo |
| Active THC and Active Ethanol | Experimental | Not described Receives: Drug: Active Dronabinol; Drug: Active Ethanol |
| Placebo THC and Active Ethanol | Experimental | Not described Receives: Drug: Placebo; Drug: Active Ethanol |
| Placebo THC and Placebo Ethanol | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline: Road Tracking Error
Measured: baseline, +100, +210 mins after start of dronabinol administration
Secondary outcomes (6)
Change from Baseline: Biphasic Alcohol Effects Scale (BAES)
A scale designed to assess the stimulant and sedative effects associated with alcohol intoxication.
Measured: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Visual Analog Scale (VAS)
Feeling states associated with alcohol and cannabis intoxication will be measured using this self-report scale of feeling states.
Measured: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Cognitive Test Battery
Several computer tasks will be administered to assess alcohol and THC effects on driving related cognition, including:
visual vigilance, visual motor function, attention and working memory, and processing speed.
Measured: baseline, +120 mins after start of dronabinol administration
Change from Baseline: Willingness to Drive Scale
Subjects will be asked to rate their willingness to drive at their current state in the context of various scenarios including willingness to drive from testing facility to a number of destinations that are different driving distances.
Measured: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Number of Joints Scale
Subjects will be asked to rate the number of standard joints that they believe they have been administered.
Measured: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Number of Drinks Scale
Subjects will be asked to rate the number of standard drinks that they believe they have been administered.
Measured: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepak C. D'Souza, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710331
- Sponsor's protocol ID
- 1501015208.C
- Acronym
- THC-ETOH-III
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2016
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III
- ClinicalTrials.gov ID
- NCT02710331
- Acronym / sponsor ID
- THC-ETOH-III / 1501015208.C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Mar 2016 (estimated)
- 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 overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.
Detailed description
To study the effects of ethanol clamped at BAC 0.04% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) on driving.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active THC and Placebo Ethanol | Experimental | Drug: Active Dronabinol, Drug: Placebo |
| Active THC and Active Ethanol | Experimental | Drug: Active Dronabinol, Drug: Active Ethanol |
| Placebo THC and Active Ethanol | Experimental | Drug: Placebo, Drug: Active Ethanol |
| Placebo THC and Placebo Ethanol | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males or females 21 to 55 years of age (extremes included).
- Exposed to cannabis at least once.
- Exposed to alcohol at least once.
- Able to provide informed consent.
Key exclusion criteria (5 listed)
- Cannabis naïve
- Alcohol naïve
- Positive pregnancy screen
- Hearing deficits
- Sesame oil allergy
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 |
|---|---|---|
| Active Dronabinol10 mg capsule of Dronabinol will be administered orally. | Drug | Active THC and Active Ethanol, Active THC and Placebo Ethanol |
| PlaceboControl: no alcohol, administered for ~80 minutes. | Drug | Active THC and Placebo Ethanol, Placebo THC and Placebo Ethanol |
| PlaceboControl: Placebo pill (no active cannabinoids) administered orally. | Drug | Placebo THC and Active Ethanol, Placebo THC and Placebo Ethanol |
| Active EthanolTarget BrAC of 0.04% reached over 20 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 2 drinks over 1 hour. Administered over a total of 80 minutes. | Drug | Active THC and Active Ethanol, Placebo THC and Active Ethanol |
Primary outcome
Change from Baseline: Road Tracking Error
Time frame: baseline, +100, +210 mins after start of dronabinol administration
6 secondary outcomes
Change from Baseline: Biphasic Alcohol Effects Scale (BAES)
Time frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Visual Analog Scale (VAS)
Time frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Cognitive Test Battery
Time frame: baseline, +120 mins after start of dronabinol administration
Change from Baseline: Willingness to Drive Scale
Time frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Number of Joints Scale
Time frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
Change from Baseline: Number of Drinks Scale
Time frame: baseline, +60, +90, +210, +360 mins after start of dronabinol administration
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 27 Apr 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Active Dronabinol and Active Ethanol in people with Cannabis and Alcohol Effect, run by Yale University 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 5 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: under way, not looking for participants, as of the sponsor's last update on 27 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. 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?
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?
Change from Baseline: Road Tracking Error (time frame: baseline, +100, +210 mins after start of dronabinol administration). 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 27 Apr 2026.