HealthyPhase 1THC-PREG-INCT02811939
Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I
A Phase 1 study testing Active Dronabinol and Active Pregnenolone in people with Healthy, run by Yale University at 1 site in United States.
Trial summary
The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG, and then assessing their responses to Dronabinol (THC). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Active Dronabinol and Active Pregnenolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2016to 9 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Exposed to cannabis at least once in lifetime
Who cannot join
- Cannabis naïve
- Individuals with a documented reaction/allergy to Pregnenolone
- Individuals with a documented reaction/allergy to Sesame oil
Trial locations and contacts
1 site in 1 country.
United States1 site
Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
West Haven, Connecticut, 06516
About this study
The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG, and then assessing their responses to Dronabinol (THC).
- Conditions
- Healthy
- Being tested
- Active Dronabinol, Active Pregnenolone, Placebo Dronabinol, Placebo Pregnenolone
- Keywords
- Cannabis, Marijuana, THC, Dronabinol, Pregnenolone, PREG, Psychotic Disorders
- Medical subject headings
- Marijuana Abuse, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active DronabinolDrug
20 mg capsule of Dronabinol will be administered orally
Active PregnenoloneDrug
1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)
Placebo DronabinolDrug
Control: Placebo pill (no active cannabinoids) administered orally
Placebo PregnenoloneDrug
Control: Placebo given sublingually (under the tongue)
| Study group | Role | What they receive |
|---|---|---|
| Active THC and Placebo Pregnenolone | Experimental | Not described Receives: Drug: Active Dronabinol; Drug: Placebo Pregnenolone |
| Active THC and Active Pregnenolone | Experimental | Not described Receives: Drug: Active Dronabinol; Drug: Active Pregnenolone |
| Placebo THC and Active Pregnenolone | Experimental | Not described Receives: Drug: Active Pregnenolone; Drug: Placebo Dronabinol |
| Placebo THC and Placebo Pregnenolone | Placebo comparator | Not described Receives: Drug: Placebo Dronabinol; Drug: Placebo Pregnenolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline: Positive and Negative Syndrome Scale (PANSS)
Positive, negative and general symptoms will be assessed using the positive, negative, and general symptom subscale of the PANSS.
Measured: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Secondary outcomes (4)
Change from Baseline: Clinician Administered Dissociative Symptoms Scale (CADSS)
Perceptual alterations will be measured using the CADSS. This is a scale consisting of 19 self-reported items, and 9 clinician-rated items. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.
Measured: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Change from Baseline: Visual Analog Scale (VAS)
Feeling states associated with cannabis intoxication will be measured using a self-reported visual analog scale of feeling states associated with cannabis effects (ex. "high, "calm", "anxious"). Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11mm line. This data will be captured to validate the experiment is relevant to cannabis effect.
Measured: Baseline; 30 minutes and 10 minutes prior to administration of oral dronabinol or placebo; 20, 90, 110, 150, 180, and 240 minutes after the administration of oral dronabinol/placebo
Change from Baseline: Psychotomimetic States Inventory (PSI)
The PSI is a measure of drug induced psychotomimetic states. This self-reported scale consists of 28 items rated 0 (not at all) to 3 (extremely) and will facilitate the characterization of a wide range of dissociative/hallucinatory phenomena as well as cognitive disorganization associated with the administration of THC.
Measured: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Cognitive Test Battery
Several computer tasks will be administered in order to evaluate the effects of cannabis on verbal learning and memory. The battery consists of five computer tasks that last no longer than 20 minutes in total.
Measured: 25 minutes after Dronabinol is given orally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start7 Apr 2016
- Primary completion9 Jun 2017
- Study completion9 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepak C. D'Souza, Yale University
- Investigators
- Deepak Cyril D'Souza, MD, Principal investigator, Yale Univerisity, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811939
- Sponsor's protocol ID
- 1501015242.A
- Acronym
- THC-PREG-I
- Status last verified
- Feb 2022
- First submitted
- 15 Mar 2016
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I
- ClinicalTrials.gov ID
- NCT02811939
- Acronym / sponsor ID
- THC-PREG-I / 1501015242.A
- Conditions
- Healthy
- Keywords
- Cannabis, Marijuana, THC, Dronabinol, Pregnenolone, PREG, Psychotic Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 9 Jun 2017 (actual)
- Study completion
- 9 Jun 2017 (actual)
- First posted
- 23 Jun 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 overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG, and then assessing their responses to Dronabinol (THC).
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 Pregnenolone | Experimental | Drug: Active Dronabinol, Drug: Placebo Pregnenolone |
| Active THC and Active Pregnenolone | Experimental | Drug: Active Dronabinol, Drug: Active Pregnenolone |
| Placebo THC and Active Pregnenolone | Experimental | Drug: Active Pregnenolone, Drug: Placebo Dronabinol |
| Placebo THC and Placebo Pregnenolone | Placebo comparator | Drug: Placebo Dronabinol, Drug: Placebo Pregnenolone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Exposed to cannabis at least once in lifetime
Key exclusion criteria (3 listed)
- Cannabis naïve
- Individuals with a documented reaction/allergy to Pregnenolone
- Individuals with a documented reaction/allergy to Sesame oil
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 Dronabinol20 mg capsule of Dronabinol will be administered orally | Drug | Active THC and Active Pregnenolone, Active THC and Placebo Pregnenolone |
| Active Pregnenolone1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue) | Drug | Active THC and Active Pregnenolone, Placebo THC and Active Pregnenolone |
| Placebo DronabinolControl: Placebo pill (no active cannabinoids) administered orally | Drug | Placebo THC and Active Pregnenolone, Placebo THC and Placebo Pregnenolone |
| Placebo PregnenoloneControl: Placebo given sublingually (under the tongue) | Drug | Active THC and Placebo Pregnenolone, Placebo THC and Placebo Pregnenolone |
Primary outcome
Change from Baseline: Positive and Negative Syndrome Scale (PANSS)
Time frame: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Positive, negative and general symptoms will be assessed using the positive, negative, and general symptom subscale of the PANSS.
4 secondary outcomes
Change from Baseline: Clinician Administered Dissociative Symptoms Scale (CADSS)
Time frame: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Change from Baseline: Visual Analog Scale (VAS)
Time frame: Baseline; 30 minutes and 10 minutes prior to administration of oral dronabinol or placebo; 20, 90, 110, 150, 180, and 240 minutes after the administration of oral dronabinol/placebo
Change from Baseline: Psychotomimetic States Inventory (PSI)
Time frame: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Cognitive Test Battery
Time frame: 25 minutes after Dronabinol is given orally
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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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.
Deepak Cyril D'Souza, MD principal investigator
Yale Univerisity, School 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 Active Dronabinol and Active Pregnenolone in people with Healthy, 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 2 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Positive and Negative Syndrome Scale (PANSS) (time frame: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo). 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 2 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.