SchizophreniaEarly Phase 1NCT00982982
Effects of Delta-9-THC and Iomazenil in Healthy Humans
A Early Phase 1 study testing THC and Iomazenil in people with Schizophrenia and Mental Disorders, run by Yale University at 1 site in United States.
Trial summary
The study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity of the brain (EEG). THC is the active ingredient of marijuana, cannabis, "ganja", or "pot". Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Mental Disorders, Psychotic Disorders
- What is being tested?
- THC and Iomazenil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2009to 22 Feb 2013
- Phase
- Early 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Exposed to cannabis at least once in their lifetime
Who cannot join
- Cannabis naïve
- History of hearing deficit
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis
The study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity of the brain (EEG). THC is the active ingredient of marijuana, cannabis, "ganja", or "pot". Iomazenil is a drug that works opposite to drugs like valium. The purpose of this study is to determine whether the administration of iomazenil will alter the effects of THC.
- Conditions
- Schizophrenia, Mental Disorders, Psychotic Disorders
- Being tested
- THC and Iomazenil, Placebo (control)
- Keywords
- Schizophrenia, Mental Disorders, Psychotic Disorders, Schizophrenia and Disorders with Psychotic Features, Cannabis
- Medical subject headings
- Schizophrenia, Mental Disorders, Psychotic Disorders, Schizophrenia Spectrum and Other Psychotic Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC and IomazenilDrug
- Iomazenil: 3.7 μg/kg intravenously over 10 minutes
- Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes.
Placebo (control)Drug
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC
| Study group | Role | What they receive |
|---|---|---|
| THC and Iomazenil | Active comparator | * Iomazenil: 3.7 μg/kg intravenously over 10 minutes
* Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes Receives: Drug: THC and Iomazenil |
| Placebo | Placebo comparator | Control: small amount of alcohol intravenous (quarter teaspoon), with no THC Receives: Drug: Placebo (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered Dissociative Symptoms Scale
Measured: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Positive and Negative Symptom Scale
Measured: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Visual Analog Scale
Measured: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Auditory Verbal Learning Test
Measured: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Perceptual Aberration Scale
Measured: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study start11 Feb 2009
- Primary completion22 Feb 2013
- Study completion22 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 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, M.D, Principal investigator, Yale University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982982
- Sponsor's protocol ID
- 0901004662
- Status last verified
- Dec 2022
- First submitted
- 18 Aug 2009
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis
- ClinicalTrials.gov ID
- NCT00982982
- Acronym / sponsor ID
- 0901004662
- Conditions
- Schizophrenia, Mental Disorders, Psychotic Disorders
- Keywords
- Schizophrenia, Mental Disorders, Psychotic Disorders, Schizophrenia and Disorders with Psychotic Features, Cannabis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 11 Feb 2009 (actual)
- Primary completion
- 22 Feb 2013 (actual)
- Study completion
- 22 Feb 2013 (actual)
- First posted
- 23 Sep 2009 (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 study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity of the brain (EEG). THC is the active ingredient of marijuana, cannabis, "ganja", or "pot". Iomazenil is a drug that works opposite to drugs like valium. The purpose of this study is to determine whether the administration of iomazenil will alter the effects of THC.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THC and Iomazenil | Active comparator | Drug: THC and Iomazenil* Iomazenil: 3.7 μg/kg intravenously over 10 minutes * Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes |
| Placebo | Placebo comparator | Drug: Placebo (control)Control: small amount of alcohol intravenous (quarter teaspoon), with no THC |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Exposed to cannabis at least once in their lifetime
Key exclusion criteria (2 listed)
- Cannabis naïve
- History of hearing deficit
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 |
|---|---|---|
| THC and Iomazenil* Iomazenil: 3.7 μg/kg intravenously over 10 minutes * Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes. | Drug | THC and Iomazenil |
| Placebo (control)Control: small amount of alcohol intravenous (quarter teaspoon), with no THC | Drug | Placebo |
Primary outcome
Clinician Administered Dissociative Symptoms Scale
Time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Positive and Negative Symptom Scale
Time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Visual Analog Scale
Time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Auditory Verbal Learning Test
Time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Perceptual Aberration Scale
Time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
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 5 Dec 2022.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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, M.D principal investigator
Yale University Medical School
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 THC and Iomazenil in people with Schizophrenia and Mental Disorders, 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 5 Dec 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?
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?
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?
Clinician Administered Dissociative Symptoms Scale (time frame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min). The study lists 5 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 5 Dec 2022.