Schizophrenia Spectrum DisordersPhase 2NCT03883360
Effects of Cannabidiol on Psychiatric Symptoms, Cognition, and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis
A Phase 2 study testing Cannabidiol (CBD) in people with Schizophrenia Spectrum Disorders and Cannabis Use, run by University of Maryland, Baltimore at 3 sites in United States.
Trial summary
A large proportion of people with a schizophrenia-spectrum disorder, especially in the early stages of the disease, regularly consume cannabis. Cannabis use is associated with poor prognostic outcome; however, there are no effective interventions targeted at reducing cannabis use or its deleterious effects in this… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia Spectrum Disorders, Cannabis Use
- What is being tested?
- Cannabidiol (CBD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2050to Mar 2050
- Phase
- Phase 2
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, and other specified or unspecified schizophrenia spectrum and other psychotic disorder.
- Experienced a first psychotic episode within the last 5 years.
- Self-reported cannabis use at least twice/week for at least the last 4 weeks.
- THCCOOH serum levels of ≥ 5 ng/mL.
- Total score ≥45 on the 18-item version of the Brief Psychiatric Rating Scale.
- Able to give written informed consent.
- Normal or corrected to normal vision.
- If medicated, no change in psychiatric medication within the preceding 4 weeks, with no foreseeable changes.
Who cannot join
- DSM-5 diagnosis of Substance Use Disorder other that cannabis or nicotine within the last year (recreational use is not exclusionary).
- Currently undergoing active treatment for Cannabis Use Disorder other than low-level (once/week or less) psychosocial intervention.
- Uncontrolled hypertension (resting systolic BP above 150 or diastolic above 95 mm Hg).
- Cardiovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, severe arrhythmias, or EKG abnormalities (Wolf-Parkinson-White syndrome, Complete left bundle branch block, PR interval <120 ms or >200 ms, Prolonged QT interval (corrected) >500 ms, Cardiac arrhythmias as defined by PACs >3 per min or PVCs >1 per min).
- History of or current neurological illness, such as stroke, seizure disorders, neurodegenerative diseases, or organic brain syndrome.
- Intellectual disability.
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- Pregnant or lactating.
- Diabetes.
- Significant kidney or liver impairment.
- Any chronic or severe infectious disease, including HIV and hepatitis.
- Cancer.
- Use of any barbiturates, diazepam, diltiazem, verapamil, protease inhibitors, any anticonvulsant medications (including valproate/valproic acid, lamotrigine, carbamazepine, and clobazam), glipizide, glyburide, warfarin, and cyclophosphamide/ ifosfamide, due to potential interaction with CBD at the metabolic level.
- Suicidal ideation currently or within last 6 months (score of >/= 3 on the Columbia Suicide Severity Rating Scale).
- Less than the lower limit of normal hemoglobin and hematocrit at screening.
- Elevated transaminase levels >3 times the ULN, accompanied by elevations in bilirubin >2 times the ULN.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sheppard Pratt Health System
Baltimore, Maryland, 21204
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, 90095
About this study
A large proportion of people with a schizophrenia-spectrum disorder, especially in the early stages of the disease, regularly consume cannabis. Cannabis use is associated with poor prognostic outcome; however, there are no effective interventions targeted at reducing cannabis use or its deleterious effects in this population. The present trial is designed to test whether cannabidiol (CBD), a cannabinoid whose effects are in many ways antagonistic to those of Δ9-tetrahydrocannabinol (THC), can reduce psychiatric symptoms, cognitive deficits, and cannabis use in people with recent-onset psychosis who regularly consume cannabis.
Read the detailed description
This is a double-blind, randomized, placebo-controlled trial, evaluating the effects of a 12-week treatment course with CBD on psychiatric symptoms, cognition, and cannabis consumption in regular cannabis users with recent-onset psychosis. The study will be conducted at the Maryland Psychiatric Research Center (University of Maryland School of Medicine) and associated Early Intervention Programs in Baltimore, at the Sheppard Pratt Health System in Baltimore, and at the Psychosis Clinic of the University of California Los Angeles.
The daily dose of CBD is 600 mg (p.o.), administered as adjunct medication. Any non-exclusionary antipsychotic, antidepressant, anxiolytic, or other medication prescribed prior to the trial will be continued. Participants may, but do not have to be taking conventional antipsychotic medication.
The study will include 84 regular cannabis users with a schizophrenia-spectrum disorder who experienced their first psychotic episode within the last 5 years (90). Participants will be randomized 1:1 to either the CBD or the placebo group.
Outcome measures include psychiatric symptoms, cognition, global functioning, and drug use, and will be assessed at baseline, and every 3 or 6 weeks thereafter (depending on the measure), until the end of treatment at 12 weeks. Outcome will be assessed again at a 3-month follow-up.
- Conditions
- Schizophrenia Spectrum Disorders, Cannabis Use
- Being tested
- Cannabidiol (CBD), Placebo
- Keywords
- schizophrenia, cannabis, cannabidiol, psychosis
- Medical subject headings
- Schizophrenia, Marijuana Abuse, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol (CBD)Drug
Participants receive a single dose of CBD (600 mg p.o.) per day for 12 weeks.
PlaceboDrug
Participants receive a single daily dose of the oil vehicle used to dissolve CBD but without any active ingredient, in the same amount as the CBD group, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Participants receive CBD daily for 12 weeks. Receives: Drug: Cannabidiol (CBD) |
| Placebo | Placebo comparator | Participants receive vehicle not containing any drug daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Psychiatric Rating Scale (BPRS) total score
The BPRS consists of 18 items assessing a broad range of psychiatric symptoms, including positive, negative, and affective symptoms. Each item is scored 1-7. Total scores are the sum of all items and range from 18 to 126, with larger values reflecting worse symptoms. The BPRS total score has been used widely in clinical studies of psychosis and has demonstrated reliability in assessing psychopathology across diverse psychosis populations.
Measured: Baseline and 12 weeks
Change in MATRICS Consensus Cognitive Battery (MCCB) composite score
The MCCB is an FDA-approved assessment tool for trials of cognition-enhancing treatments in people with schizophrenia. The MCCB is comprised of the following domains: 1) Speed of Processing; 2) Attention/Vigilance; 3) Working Memory; 4) Verbal Learning; 5) Visual Learning; 6) Reasoning and Problem Solving; and 7) Social Cognition. The composite score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Higher scores reflect better performance.
Measured: Baseline and 12 weeks
Change in Serum concentrations of THCCOOH
THCCOOH is a THC metabolite and is used to quantify cannabis consumption. It has a long half-life (5-6 days) and thus provides a summary index of cannabis use within the last 1-2 weeks.
Measured: Baseline and 12 weeks
Secondary outcomes (18)
Change in BPRS positive symptoms
The average of four BPRS key positive symptom items (conceptual disorganization, suspiciousness, unusual thought content, and hallucinatory behavior) will be analyzed as an index of antipsychotic effects of CBD. Possible values range from 1 to 7, with larger values reflecting more severe positive symptoms.
Measured: Baseline and 12 weeks
Change in BPRS "Anxiety/Depression" subscale
This subscale will be analyzed separately to obtain an index of the anxiolytic effects of CBD. Possible values range from 1 to 7, with larger values reflecting more anxiety/depression.
Measured: Baseline and 12 weeks
Change in State-Trait Anxiety Inventory (STAI) - State version
The STAI-State provides another probe for potential anxiolytic effects of CBD. The participant rates 20 items about how they feel right now and a scale from 1 (not at all) to 4 (very much so). The total score is derived by adding all values and ranges from 20 to 80, with larger values indicating greater anxiety.
Measured: Baseline and 12 weeks
Change in MCCB Processing Speed subscale
The score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Higher scores reflect better performance.
Measured: Baseline and 12 weeks
Change in MCCB Attention/Vigilance subscale
The score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Higher scores reflect better performance.
Measured: Baseline and 12 weeks
Change in MCCB Working Memory subscale
The score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Higher scores reflect better performance.
Measured: Baseline and 12 weeks
Change in MCCB Verbal Learning subscale
The score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Higher scores reflect better performance.
Measured: Baseline and 12 weeks
Change in MCCB Visual Learning subscale
The score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Higher scores reflect better performance.
Measured: Baseline and 12 weeks
Change in MCCB Reasoning/Problem solving subscale
The score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Higher scores reflect better performance.
Measured: Baseline and 12 weeks
Change in MCCB Social Cognition subscale
The score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Higher scores reflect better performance.
Measured: Baseline and 12 weeks
Change in The UCSD Performance-Based Skills Assessment (UPSA)
Measures ability to perform real-life tasks by standardized role-play. Scores reflect percent correct, i.e. range from 0-100, with larger scores reflecting better performance.
Measured: Baseline and 12 weeks
Change in Serum concentrations of THC
Index of recent cannabis use.
Measured: Baseline and 12 weeks
Change in Self-reported days of cannabis use
The reference period is the last three weeks. Thus, possible values range from 0 to 21.
Measured: Baseline and 12 weeks
Change in Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
The CUDIT-R is an 8-item questionnaire probing cannabis use frequency, amount, loss of control, and adverse consequences in the last 6 months. Each item is rated on a scale from 0 to 4. The total score is derived by summing all answers and ranges from 0 to 32, with larger values representing greater use severity.
Measured: Baseline and 12 weeks
Change in Specific Levels of Functioning scale (SLOF)
An index of real-world, everyday functioning, derived by summing 30 item scores (1-5). Higher scores reflect better functioning.
Measured: Baseline and 12 weeks
Change in Behavior And Symptom Identification Scale (BASIS) - revised
A self-report questionnaire to assess mental health treatment outcomes. Only the first 24 items (probing daily life functioning, social behavior, and mood) are included, each scored on a scale from 0 to 4. The total score is derived by summing individual item scores are re-poling some items, with larger values representing worse outcome.
Measured: Baseline and 12 weeks
Change in Serum concentrations of CBD
To confirm bioavailability of the study drug.
Measured: Baseline and 12 weeks
Change in Serum concentrations of anandamide
Anandamide is an endocannabinoid that has been reported to be down-regulated by cannabis use and up-regulated by CBD.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study startJan 2050 (estimated)
- Primary completionFeb 2050 (estimated)
- Study completionMar 2050 (estimated)
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to either the cannabidiol group or the placebo group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Sheppard Pratt Health System, University of California, Los Angeles
- Responsible party
- Principal investigator, Britta Hahn, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883360
- Sponsor's protocol ID
- HP-00082213
- Status last verified
- Apr 2021
- First submitted
- 14 Mar 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabidiol on Psychiatric Symptoms, Cognition, and Cannabis Consumption in Cannabis Users With Recent-Onset Psychosis
- ClinicalTrials.gov ID
- NCT03883360
- Acronym / sponsor ID
- HP-00082213
- Conditions
- Schizophrenia Spectrum Disorders, Cannabis Use
- Keywords
- schizophrenia, cannabis, cannabidiol, psychosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Sheppard Pratt Health System, University of California, Los Angeles
- Study start
- Jan 2050 (estimated)
- Primary completion
- Feb 2050 (estimated)
- Study completion
- Mar 2050 (estimated)
- First posted
- 20 Mar 2019 (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.
A large proportion of people with a schizophrenia-spectrum disorder, especially in the early stages of the disease, regularly consume cannabis. Cannabis use is associated with poor prognostic outcome; however, there are no effective interventions targeted at reducing cannabis use or its deleterious effects in this population. The present trial is designed to test whether cannabidiol (CBD), a cannabinoid whose effects are in many ways antagonistic to those of Δ9-tetrahydrocannabinol (THC), can reduce psychiatric symptoms, cognitive deficits, and cannabis use in people with recent-onset psychosis who regularly consume cannabis.
Detailed description
This is a double-blind, randomized, placebo-controlled trial, evaluating the effects of a 12-week treatment course with CBD on psychiatric symptoms, cognition, and cannabis consumption in regular cannabis users with recent-onset psychosis. The study will be conducted at the Maryland Psychiatric Research Center (University of Maryland School of Medicine) and associated Early Intervention Programs in Baltimore, at the Sheppard Pratt Health System in Baltimore, and at the Psychosis Clinic of the University of California Los Angeles.
The daily dose of CBD is 600 mg (p.o.), administered as adjunct medication. Any non-exclusionary antipsychotic, antidepressant, anxiolytic, or other medication prescribed prior to the trial will be continued. Participants may, but do not have to be taking conventional antipsychotic medication.
The study will include 84 regular cannabis users with a schizophrenia-spectrum disorder who experienced their first psychotic episode within the last 5 years (90). Participants will be randomized 1:1 to either the CBD or the placebo group.
Outcome measures include psychiatric symptoms, cognition, global functioning, and drug use, and will be assessed at baseline, and every 3 or 6 weeks thereafter (depending on the measure), until the end of treatment at 12 weeks. Outcome will be assessed again at a 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to either the cannabidiol group or the placebo group.
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Drug: Cannabidiol (CBD)Participants receive CBD daily for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive vehicle not containing any drug daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, and other specified or unspecified schizophrenia spectrum and other psychotic disorder.
- Experienced a first psychotic episode within the last 5 years.
- Self-reported cannabis use at least twice/week for at least the last 4 weeks.
- THCCOOH serum levels of ≥ 5 ng/mL.
- Total score ≥45 on the 18-item version of the Brief Psychiatric Rating Scale.
Key exclusion criteria (15 listed)
- DSM-5 diagnosis of Substance Use Disorder other that cannabis or nicotine within the last year (recreational use is not exclusionary).
- Currently undergoing active treatment for Cannabis Use Disorder other than low-level (once/week or less) psychosocial intervention.
- Uncontrolled hypertension (resting systolic BP above 150 or diastolic above 95 mm Hg).
- Cardiovascular disease, such as history of myocardial infarction and ischemia, heart failure, angina, severe arrhythmias, or EKG abnormalities (Wolf-Parkinson-White syndrome, Complete left bundle branch block, PR interval <120 ms or >200 ms, Prolonged QT interval (corrected) >500 ms, Cardiac arrhythmias as defined by PACs >3 per min or PVCs >1 per min).
- History of or current neurological illness, such as stroke, seizure disorders, neurodegenerative diseases, or organic brain syndrome.
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 |
|---|---|---|
| Cannabidiol (CBD)Participants receive a single dose of CBD (600 mg p.o.) per day for 12 weeks. | Drug | Cannabidiol (CBD) |
| PlaceboParticipants receive a single daily dose of the oil vehicle used to dissolve CBD but without any active ingredient, in the same amount as the CBD group, for 12 weeks. | Drug | Placebo |
Primary outcome
Change in Brief Psychiatric Rating Scale (BPRS) total score
Time frame: Baseline and 12 weeks
The BPRS consists of 18 items assessing a broad range of psychiatric symptoms, including positive, negative, and affective symptoms. Each item is scored 1-7. Total scores are the sum of all items and range from 18 to 126, with larger values reflecting worse symptoms. The BPRS total score has been used widely in clinical studies of psychosis and has demonstrated reliability in assessing psychopathology across diverse psychosis populations.
Change in MATRICS Consensus Cognitive Battery (MCCB) composite score
Time frame: Baseline and 12 weeks
The MCCB is an FDA-approved assessment tool for trials of cognition-enhancing treatments in people with schizophrenia. The MCCB is comprised of the following domains: 1) Speed of Processing; 2) Attention/Vigilance; 3) Working Memory; 4) Verbal Learning; 5) Visual Learning; 6) Reasoning and Problem Solving; and 7) Social Cognition. The composite score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Higher scores reflect better performance.
Change in Serum concentrations of THCCOOH
Time frame: Baseline and 12 weeks
THCCOOH is a THC metabolite and is used to quantify cannabis consumption. It has a long half-life (5-6 days) and thus provides a summary index of cannabis use within the last 1-2 weeks.
18 secondary outcomes
Change in BPRS positive symptoms
Time frame: Baseline and 12 weeks
Change in BPRS "Anxiety/Depression" subscale
Time frame: Baseline and 12 weeks
Change in State-Trait Anxiety Inventory (STAI) - State version
Time frame: Baseline and 12 weeks
Change in MCCB Processing Speed subscale
Time frame: Baseline and 12 weeks
Change in MCCB Attention/Vigilance subscale
Time frame: Baseline and 12 weeks
Change in MCCB Working Memory subscale
Time frame: Baseline and 12 weeks
Change in MCCB Verbal Learning subscale
Time frame: Baseline and 12 weeks
Change in MCCB Visual Learning subscale
Time frame: Baseline and 12 weeks
Change in MCCB Reasoning/Problem solving subscale
Time frame: Baseline and 12 weeks
Change in MCCB Social Cognition subscale
Time frame: Baseline and 12 weeks
Change in The UCSD Performance-Based Skills Assessment (UPSA)
Time frame: Baseline and 12 weeks
Change in Serum concentrations of THC
Time frame: Baseline and 12 weeks
Change in Self-reported days of cannabis use
Time frame: Baseline and 12 weeks
Change in Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
Time frame: Baseline and 12 weeks
Change in Specific Levels of Functioning scale (SLOF)
Time frame: Baseline and 12 weeks
Change in Behavior And Symptom Identification Scale (BASIS) - revised
Time frame: Baseline and 12 weeks
Change in Serum concentrations of CBD
Time frame: Baseline and 12 weeks
Change in Serum concentrations of anandamide
Time frame: Baseline and 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol (CBD) in people with Schizophrenia Spectrum Disorders and Cannabis Use, run by University of Maryland, Baltimore at 3 sites 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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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 Brief Psychiatric Rating Scale (BPRS) total score (time frame: Baseline and 12 weeks). The study lists 3 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 19 Apr 2021.