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Cannabinoid
Cannabis Components for Bipolar Disorder
Phase < 1
Waitlist Available
Led By William Perry, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
Infections - evidence of skin infection at lumbar puncture site.
To avoid confounding of cognitive testing, a neurological disorder such as seizures, stroke, Parkinson's disease, dementia, or a history of head injury with loss of consciousness for at least 15 minutes will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one day
Awards & highlights
Summary
This trial will study the effects of cannabis on people with bipolar disorder to see if it affects cognition. They will test different doses of two major components of cannabis, cannabidiol and ∆9-tetrahydrocannabinol, and compare them to placebo.
Who is the study for?
This trial is for adults with Bipolar Disorder who use cannabis infrequently (no more than 4 times a month) and have low manic symptoms. They must not be heavy users of other substances, have significant medical conditions, or be pregnant. Participants should not drive after taking the study medication and must agree to birth control measures.Check my eligibility
What is being tested?
The trial tests how different doses of cannabinoids (Dronabinol and Epidiolex) versus placebo affect cognition in Bipolar Disorder patients and healthy volunteers. It also examines the impact on brain chemicals related to mood and perception.See study design
What are the potential side effects?
Potential side effects may include changes in alertness, mood alterations, coordination issues, digestive discomforts, or allergic reactions. Specific risks will depend on individual responses to cannabinoid exposure.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a skin infection where a spinal tap would be performed.
Select...
I do not have a history of major neurological disorders or significant head injuries.
Select...
I can walk on my own without needing a wheelchair and do not have a motor disease.
Select...
I do not have any active infections or cancers needing immediate treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Prepulse Inhibition (PPI)
Score on Iowa Gambling Task
Score on Progressive Ratio Test
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bipolar DisorderExperimental Treatment3 Interventions
adults with bipolar disorder
Group II: Healthy VolunteersActive Control3 Interventions
adults with no psychiatric disease
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dronabinol
2003
Completed Phase 4
~2080
Epidiolex
2020
Completed Phase 2
~380
Placebos
2019
Completed Phase 4
~2030
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,135 Previous Clinical Trials
1,551,225 Total Patients Enrolled
12 Trials studying Bipolar Disorder
1,929 Patients Enrolled for Bipolar Disorder
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,564 Total Patients Enrolled
15 Trials studying Bipolar Disorder
1,636 Patients Enrolled for Bipolar Disorder
William Perry, PhDPrincipal Investigator - UCSD
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Subjects in the BD group must meet DSM-5 criteria for Bipolar Disorder as ascertained by the Structured Clinical Interview for DSM-5 (SCID).Your score on the Young Mania Rating Scale is less than 12, indicating a lower likelihood of manic episodes.I use cannabis no more than 4 times a month.You abstain from cannabis use for a minimum of two days before the study appointment.I do not have serious heart, liver, kidney, blood pressure, or lung problems and am not pregnant or breastfeeding.I have a skin infection where a spinal tap would be performed.I do not have a history of major neurological disorders or significant head injuries.I can walk on my own without needing a wheelchair and do not have a motor disease.I am willing to use birth control during the study.I do not have any active infections or cancers needing immediate treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Bipolar Disorder
- Group 2: Healthy Volunteers
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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