Delta-9-TetrahydroncannabinolPhase 1THC-BDNCT03206463
Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder
A Phase 1 study testing 4 mg Delta-9-THC and 2 mg Delta-9-THC in people with Delta-9-Tetrahydroncannabinol and Bipolar Disorder, run by Yale University at 1 site in United States.
Trial summary
The overarching goal of this study is to characterize the acute cognitive and psychophysiological effects of the main psychoactive constituent of cannabis, 9-delta-tetrahydrocannabinol (THC) in individuals with euthymic bipolar disorder (BD), and to begin probing the mechanisms that may underlie its effects in this… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Delta-9-Tetrahydroncannabinol, Bipolar Disorder, Healthy Controls
- What is being tested?
- 4 mg Delta-9-THC and 2 mg Delta-9-THC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 29 Sep 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
- Men and women aged approximately 18-55 years (extremes included).
- Able to provide informed consent in English.
- No psychiatric diagnoses and in good physical health.
- General exclusion criteria:
- Cannabis naïve
- Unwillingness to remain alcohol-free, cannabis-free for at least 1 week (in infrequent cannabis users) prior to each test day.
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- Evidence of a hearing deficit.
- IQ less than 80.
- Positive pregnancy test, lactation, and refusal to practice birth control.
Who cannot join
None listed.
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 acute cognitive and psychophysiological effects of the main psychoactive constituent of cannabis, 9-delta-tetrahydrocannabinol (THC) in individuals with euthymic bipolar disorder (BD), and to begin probing the mechanisms that may underlie its effects in this illness.
This study is expected to contribute to a better characterization of specific effects of THC in individuals with BD compared to healthy controls (HC).
Read the detailed description
To compare the dose related acute effects of inhaled THC, administered through a vaporizer over approximately 20 minutes, between HC and euthymic BD individuals (referred to as eBD) on a range of subjective and objective parameters as described below:
Primary Aims:
- Verbal memory, measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT) and/or the CogState battery, administered while EEG data is collected.
- Executive functioning measured by the CogState battery and/or Trails Making Test-Part B.
Secondary Aims:
- Attention, measured by the Continuous Performance Test-Identical Pairs (CPT-IP).
- Working memory, measured by the Wechsler Memory Scale-3 Letter-Number Sequencing.
- Mood, measured by the Profile of Mood States (POMS).
- Psychotic-type experiences, measured by the Psychotomimetic States Inventory (PSI) and/or the Clinician Administered Dissociative Symptoms Scale (CADSS).
- Anxiety symptoms, measured by the Visual Analog Scale for Anxiety (VAS-A).
- Impulsivity, measured by the Balloon Analogue Risk Task (BART).
Exploratory aims:
•Serum prolactin, serum ACTH, serum cortisol and serum endocannabinoid levels.
- Being tested
- 4 mg Delta-9-THC, Placebo, 2 mg Delta-9-THC
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mg Delta-9-THCDrug
Subject will have 1/3 chance of receiving 4 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
PlaceboDrug
Subject will have 1/3 chance of receiving the inhaled placebo condition administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. The placebo condition will include no active cannabinoids.
2 mg Delta-9-THCDrug
Subject will have 1/3 chance of receiving 2 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
| Study group | Role | What they receive |
|---|---|---|
| Active 4 mg inhaled THC | Experimental | Subject will have 1/3 chance of receiving 4 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. Receives: Drug: 4 mg Delta-9-THC |
| Active 2 mg inhaled THC | Experimental | Subject will have 1/3 chance of receiving 2 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. Receives: Drug: 2 mg Delta-9-THC |
| Placebo | Placebo comparator | Subject will have 1/3 chance of receiving the inhaled placebo condition administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. The placebo condition will include no active cannabinoids. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Verbal memory
Verbal memory will be measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT) and/or the CogState battery, administered while EEG data is collected.
Measured: baseline and +35 mins after drug administration
Change in Executive functioning
Executive functioning will be measured by the CogState battery and/or Trails Making Test-Part B.
Measured: baseline and +35 mins after drug administration
Secondary outcomes (6)
Attention
Attention will be measured by the Continuous Performance Test-Identical Pairs (CPT-IP).
Measured: baseline and +35 mins after drug administration
Working memory
Working memory will be tested by the Wechsler Memory Scale-3 Letter-Number Sequencing.
Measured: baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Mood
Mood will be measured by the Profile of Mood States (POMS).
Measured: baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Psychotic-type experiences
Psychotic-type experiences will be measured by the Psychotomimetic States Inventory (PSI) and/or the Clinician Administered Dissociative Symptoms Scale (CADSS).
Measured: baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Anxiety symptoms
Anxiety symptoms will be measured by the Visual Analog Scale for Anxiety (VAS-A).
Measured: baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Impulsivity
Impulsivity will be measured by the Balloon Analogue Risk Task (BART).
Measured: baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Aug 2017
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Why it stopped: Feasibility pilot was completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delta-9-TetrahydroncannabinolStudies 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
- Model description
- The study is a double-blind, randomized, placebo-controlled, crossover laboratory evaluation of the acute subjective, cognitive and psychophysiological effects of 2 mg and 4 mg inhaled THC in Healthy Control individuals and individuals with euthymic Bipolar Disorder.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
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
- NCT03206463
- Sponsor's protocol ID
- 2000020272
- Acronym
- THC-BD
- Status last verified
- Jan 2022
- First submitted
- 19 Jun 2017
- Last updated
- 31 Jan 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 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Psychophysiological Effects of Delta-9-Tetrahydrocannabinol in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03206463
- Acronym / sponsor ID
- THC-BD / 2000020272
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility pilot was completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 2 Jul 2017 (actual)
- 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 acute cognitive and psychophysiological effects of the main psychoactive constituent of cannabis, 9-delta-tetrahydrocannabinol (THC) in individuals with euthymic bipolar disorder (BD), and to begin probing the mechanisms that may underlie its effects in this illness.
This study is expected to contribute to a better characterization of specific effects of THC in individuals with BD compared to healthy controls (HC).
Detailed description
To compare the dose related acute effects of inhaled THC, administered through a vaporizer over approximately 20 minutes, between HC and euthymic BD individuals (referred to as eBD) on a range of subjective and objective parameters as described below:
Primary Aims:
- Verbal memory, measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT) and/or the CogState battery, administered while EEG data is collected.
- Executive functioning measured by the CogState battery and/or Trails Making Test-Part B.
Secondary Aims:
- Attention, measured by the Continuous Performance Test-Identical Pairs (CPT-IP).
- Working memory, measured by the Wechsler Memory Scale-3 Letter-Number Sequencing.
- Mood, measured by the Profile of Mood States (POMS).
- Psychotic-type experiences, measured by the Psychotomimetic States Inventory (PSI) and/or the Clinician Administered Dissociative Symptoms Scale (CADSS).
- Anxiety symptoms, measured by the Visual Analog Scale for Anxiety (VAS-A).
- Impulsivity, measured by the Balloon Analogue Risk Task (BART).
Exploratory aims:
•Serum prolactin, serum ACTH, serum cortisol and serum endocannabinoid levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is a double-blind, randomized, placebo-controlled, crossover laboratory evaluation of the acute subjective, cognitive and psychophysiological effects of 2 mg and 4 mg inhaled THC in Healthy Control individuals and individuals with euthymic Bipolar Disorder.
| Arm | Type | Receives |
|---|---|---|
| Active 4 mg inhaled THC | Experimental | Drug: 4 mg Delta-9-THCSubject will have 1/3 chance of receiving 4 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. |
| Active 2 mg inhaled THC | Experimental | Drug: 2 mg Delta-9-THCSubject will have 1/3 chance of receiving 2 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. |
| Placebo | Placebo comparator | Drug: PlaceboSubject will have 1/3 chance of receiving the inhaled placebo condition administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. The placebo condition will include no active cannabinoids. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Men and women aged approximately 18-55 years (extremes included).
- Able to provide informed consent in English.
- No psychiatric diagnoses and in good physical health.
- Cannabis naïve
- Unwillingness to remain alcohol-free, cannabis-free for at least 1 week (in infrequent cannabis users) prior to each test day.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 4 mg Delta-9-THCSubject will have 1/3 chance of receiving 4 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. | Drug | Active 4 mg inhaled THC |
| PlaceboSubject will have 1/3 chance of receiving the inhaled placebo condition administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. The placebo condition will include no active cannabinoids. | Drug | Placebo |
| 2 mg Delta-9-THCSubject will have 1/3 chance of receiving 2 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. | Drug | Active 2 mg inhaled THC |
Primary outcome
Change in Verbal memory
Time frame: baseline and +35 mins after drug administration
Verbal memory will be measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT) and/or the CogState battery, administered while EEG data is collected.
Change in Executive functioning
Time frame: baseline and +35 mins after drug administration
Executive functioning will be measured by the CogState battery and/or Trails Making Test-Part B.
6 secondary outcomes
Attention
Time frame: baseline and +35 mins after drug administration
Working memory
Time frame: baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Mood
Time frame: baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Psychotic-type experiences
Time frame: baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Anxiety symptoms
Time frame: baseline and +20 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Impulsivity
Time frame: baseline, +35 mins after drug administration, +90 mins after drug administration and +210 mins after drug administration
Results and safety
The study was stopped early (reason given: Feasibility pilot was completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
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 Phase 1 study testing 4 mg Delta-9-THC and 2 mg Delta-9-THC in people with Delta-9-Tetrahydroncannabinol and Bipolar Disorder, 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 9 inclusion and 0 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: stopped early, as of the sponsor's last update on 31 Jan 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 was stopped early (reason given: Feasibility pilot was completed). Results are not available in the source record.
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 in Verbal memory (time frame: baseline and +35 mins after drug administration). The study lists 2 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 31 Jan 2022.