HealthyPhase 1THC-PregNCT02576912
Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone
A Phase 1 study testing Active Delta-9-THC 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 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 Delta-9-THC and Active Pregnenolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 24 Jun 2019
- 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 naive
- Individuals with a documented reaction/allergy to Pregnenolone
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 THC.
- Conditions
- Healthy
- Being tested
- Active Delta-9-THC, Active Pregnenolone, Placebo
- Keywords
- Cannabis, Marijuana, THC, Pregnenolone, Psychotic Disorders, PREG
- 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 Delta-9-THCDrug
Active Delta-9-THC (0.036 mg/kg) given intravenously.
Active PregnenoloneDrug
A dose given sublingually.
PlaceboDrug
A placebo dose given sublingually.
PlaceboDrug
Placebo dose given intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Active Delta-9-THC and Placebo Pregnenolone | Experimental | Not described Receives: Drug: Active Delta-9-THC; Drug: Placebo |
| Active Delta-9-THC and Active Pregnenolone | Experimental | Not described Receives: Drug: Active Delta-9-THC; Drug: Active Pregnenolone |
| Placebo Delta-9-THC and Active Pregnenolone | Experimental | Not described Receives: Drug: Active Pregnenolone; Drug: Placebo |
| Placebo Delta-9-THC and Placebo Pregnenolone | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS.
Measured: Baseline, +110, +180, and +240 minutes after start of THC Infusion
Secondary outcomes (4)
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; +15, +110, +180, and +240 minutes after start of THC infusion
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. These data will be captured to validate that the experiment is relevant to cannabis effects.
Measured: Baseline; +15, +110, +180, and +240 minutes after start of THC infusion
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; +110, +180, and +240 minutes after start of THC infusion
Cognitive Test Battery
Several computer tasks will be administered in order to evaluate the effects of cannabis on verbal learning and memory, visual recognition, spatial working memory, and working memory. The battery consists of five computer tasks that lasts no longer than 20 minutes in total.
Measured: 25 minutes after start of THC infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
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
- 38 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 C D'Souza, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576912
- Sponsor's protocol ID
- 1501015242
- Acronym
- THC-Preg
- Status last verified
- Aug 2023
- First submitted
- 24 Mar 2015
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. 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
- ClinicalTrials.gov ID
- NCT02576912
- Acronym / sponsor ID
- THC-Preg / 1501015242
- Conditions
- Healthy
- Keywords
- Cannabis, Marijuana, THC, Pregnenolone, Psychotic Disorders, PREG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 15 Oct 2015 (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 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 Delta-9-THC and Placebo Pregnenolone | Experimental | Drug: Active Delta-9-THC, Drug: Placebo |
| Active Delta-9-THC and Active Pregnenolone | Experimental | Drug: Active Delta-9-THC, Drug: Active Pregnenolone |
| Placebo Delta-9-THC and Active Pregnenolone | Experimental | Drug: Active Pregnenolone, Drug: Placebo |
| Placebo Delta-9-THC and Placebo Pregnenolone | Placebo comparator | Drug: Placebo |
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 (2 listed)
- Cannabis naive
- Individuals with a documented reaction/allergy to Pregnenolone
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 Delta-9-THCActive Delta-9-THC (0.036 mg/kg) given intravenously. | Drug | Active Delta-9-THC and Active Pregnenolone, Active Delta-9-THC and Placebo Pregnenolone |
| Active PregnenoloneA dose given sublingually. | Drug | Active Delta-9-THC and Active Pregnenolone, Placebo Delta-9-THC and Active Pregnenolone |
| PlaceboA placebo dose given sublingually. | Drug | Active Delta-9-THC and Placebo Pregnenolone, Placebo Delta-9-THC and Placebo Pregnenolone |
| PlaceboPlacebo dose given intravenously. | Drug | Placebo Delta-9-THC and Active Pregnenolone, Placebo Delta-9-THC and Placebo Pregnenolone |
Primary outcome
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: Baseline, +110, +180, and +240 minutes after start of THC Infusion
Positive, negative, and general symptoms will be assessed using the positive, negative, and general symptom subscales of the PANSS.
4 secondary outcomes
Clinician Administered Dissociative Symptoms Scale (CADSS)
Time frame: Baseline; +15, +110, +180, and +240 minutes after start of THC infusion
Visual Analog Scale (VAS)
Time frame: Baseline; +15, +110, +180, and +240 minutes after start of THC infusion
Psychotomimetic States Inventory (PSI)
Time frame: Baseline; +110, +180, and +240 minutes after start of THC infusion
Cognitive Test Battery
Time frame: 25 minutes after start of THC infusion
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 7 Aug 2023.
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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 C D'Souza, MD principal investigator
Yale University
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 Delta-9-THC 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 2 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 7 Aug 2023. 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?
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) (time frame: Baseline, +110, +180, and +240 minutes after start of THC Infusion). 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 7 Aug 2023.