PsychosisEarly Phase 1NCT02102113
Probing the Cannabinoid System in Individuals With a Family History of Psychosis
A Early Phase 1 study testing Very Low Dose THC and Low Dose THC in people with Psychosis and Cannabis Use, run by Yale University at 1 site in United States.
Trial summary
The overall purpose of this study is to determine whether a family history of psychosis is associated with an altered cannabinoid system. This will be tested by studying individuals with and without a family history of psychosis and comparing their responses to delta 9-tetrahydrocannabinol (THC), a probe of the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Cannabis Use, THC
- What is being tested?
- Very Low Dose THC and Low Dose THC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2026
- Phase
- Early 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Exposure to cannabis at least once in their lifetime
- Medically and psychiatrically healthy based on screening
- Having one relative with a confirmed psychotic disorder
- Exposure to cannabis at least once in their lifetime
- Medically and psychiatrically healthy based on screening
Who cannot join
- Current or lifetime major DSM-IV Axis I disorder
- Current or lifetime treatment (at least 6 months) with psychotropic medications for major psychiatric or neurological illness
- Major or unstable medical illness that might impact safety of the subject in the study
- Cannabis naive
- IQ less than 85
- Less than a high school diploma or its educational equivalent
Show all 17Show fewer
- Pregnancy or lactation
- Major current or recent (<6 weeks) psychosocial stressors.
- Having a family member with psychosis
- Current or lifetime major DSM-IV Axis I disorder
- Current or lifetime treatment (at least 6 months) with psychotropic medications for major psychiatric or neurological illness
- Major or unstable medical illness that might impact safety of the subject in the study
- Cannabis naive
- IQ less than 85
- Less than a high school diploma or its educational equivalent
- Pregnancy or lactation
- Major current or recent (<6 weeks) psychosocial stressors.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
The overall purpose of this study is to determine whether a family history of psychosis is associated with an altered cannabinoid system. This will be tested by studying individuals with and without a family history of psychosis and comparing their responses to delta 9-tetrahydrocannabinol (THC), a probe of the cannabinoid system. We hypothesize, that compared to controls with no family history of psychoses, individuals with a family history of psychoses will have an altered response to THC.
- Conditions
- Psychosis, Cannabis Use, THC, Marijuana, Schizophrenia
- Being tested
- Placebo, Very Low Dose THC, Low Dose THC
- Medical subject headings
- Psychotic Disorders, Marijuana Abuse, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo
Very Low Dose THCDrug
Also called delta 9-tetrahydrocannabinol
Subjects will receive 0.010mg/kg.
Low Dose THCDrug
Also called delta 9-tetrahydrocannabinol
Subjects will receive 0.018 mg/kg over 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| No Family History of Psychosis (FHN) | Other | Individuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions. Receives: Drug: Placebo; Drug: Very Low Dose THC; Drug: Low Dose THC |
| Family History of Psychosis (FHP) | Experimental | Individuals with a family member with a confirmed diagnosis of psychosis. They will receive the placebo, very low dose THC, and low dose THC interventions. Receives: Drug: Placebo; Drug: Very Low Dose THC; Drug: Low Dose THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Measured: -30 min from administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Measured: +80 min from administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Measured: +150 min of administration of THC
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Measured: +240 min of administration of THC
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-report items and 8 clinician-rated items (0=not at all, 4=extremely). The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.
Measured: -30 min, +15 min, +80 min, +150 min, +240 min
Visual Analog Scale (VAS)
Feeling states associated with cannabis intoxication will be measured using a self-reported visual analogue scale of four feeling states ("high", "anxious", "calm and relaxed", and "tired") associated with cannabis effects. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11 mm line (0=not at all, 100=extremely). These data will be captured to validate that the experiment is relevant to cannabis effects.
Measured: -30 min, +15 min, +80 min, +150 min, +240 min
Hopkins Verbal Learning Test (HVLT)
The HVLT is a 12 word list that is semantically organized. The task consists of 5 trials, an interference list, and free delayed recall and recognition. A different version of the AVLT will be administered on each test day and counterbalanced across subjects.
Measured: +50 min
Psychotomimetic States Inventory (PSI)
The PSI is a measure of drug induced psychotomimetic states. This self-report 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: -30 min, +240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionJun 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 PsychosisStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohini Ranganathan, Yale University
- Investigators
- Mohini Ranganathan, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102113
- Sponsor's protocol ID
- 1310012948
- Status last verified
- Aug 2024
- First submitted
- 26 Mar 2014
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing the Cannabinoid System in Individuals With a Family History of Psychosis
- ClinicalTrials.gov ID
- NCT02102113
- Acronym / sponsor ID
- 1310012948
- Conditions
- Psychosis, Cannabis Use, THC, Marijuana, Schizophrenia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Apr 2014 (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 determine whether a family history of psychosis is associated with an altered cannabinoid system. This will be tested by studying individuals with and without a family history of psychosis and comparing their responses to delta 9-tetrahydrocannabinol (THC), a probe of the cannabinoid system. We hypothesize, that compared to controls with no family history of psychoses, individuals with a family history of psychoses will have an altered response to THC.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Family History of Psychosis (FHN) | Other | Drug: Placebo, Drug: Very Low Dose THC, Drug: Low Dose THCIndividuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions. |
| Family History of Psychosis (FHP) | Experimental | Drug: Placebo, Drug: Very Low Dose THC, Drug: Low Dose THCIndividuals with a family member with a confirmed diagnosis of psychosis. They will receive the placebo, very low dose THC, and low dose THC interventions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Exposure to cannabis at least once in their lifetime
- Medically and psychiatrically healthy based on screening
- Having one relative with a confirmed psychotic disorder
- Exposure to cannabis at least once in their lifetime
- Medically and psychiatrically healthy based on screening
Key exclusion criteria (17 listed)
- Current or lifetime major DSM-IV Axis I disorder
- Current or lifetime treatment (at least 6 months) with psychotropic medications for major psychiatric or neurological illness
- Major or unstable medical illness that might impact safety of the subject in the study
- Cannabis naive
- IQ less than 85
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 |
|---|---|---|
| Placeboplacebo | Drug | Family History of Psychosis (FHP), No Family History of Psychosis (FHN) |
| Very Low Dose THCAlso: delta 9-tetrahydrocannabinolSubjects will receive 0.010mg/kg. | Drug | Family History of Psychosis (FHP), No Family History of Psychosis (FHN) |
| Low Dose THCAlso: delta 9-tetrahydrocannabinolSubjects will receive 0.018 mg/kg over 20 minutes. | Drug | Family History of Psychosis (FHP), No Family History of Psychosis (FHN) |
Primary outcome
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time frame: -30 min from administration of THC
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time frame: +80 min from administration of THC
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time frame: +150 min of administration of THC
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Time frame: +240 min of administration of THC
Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.
4 secondary outcomes
Clinician Administered Dissociative Symptoms Scale (CADSS)
Time frame: -30 min, +15 min, +80 min, +150 min, +240 min
Visual Analog Scale (VAS)
Time frame: -30 min, +15 min, +80 min, +150 min, +240 min
Hopkins Verbal Learning Test (HVLT)
Time frame: +50 min
Psychotomimetic States Inventory (PSI)
Time frame: -30 min, +240 min
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 10 Jun 2025.
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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.
Mohini Ranganathan, 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 Early Phase 1 study testing Very Low Dose THC and Low Dose THC in people with Psychosis and Cannabis Use, 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 5 inclusion and 17 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 10 Jun 2025. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Positive and Negative Symptom Scale for Schizophrenia (PANSS) (time frame: -30 min from administration of THC). The study lists 4 primary outcomes in all. 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 10 Jun 2025.