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Cannabinoid

Cannabis Components for Bipolar Disorder

Phase < 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one day
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one day
This trial's timeline: 3 weeks for screening, Varies for treatment, and one day for reporting.

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 more

Trial 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
1,120 Previous Clinical Trials
1,521,491 Total Patients Enrolled
12 Trials studying Bipolar Disorder
1,929 Patients Enrolled for Bipolar Disorder
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,449 Total Patients Enrolled
15 Trials studying Bipolar Disorder
1,636 Patients Enrolled for Bipolar Disorder
William Perry, PhDPrincipal Investigator - UCSD

Media Library

Dronabinol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04231643 — Phase < 1
Bipolar Disorder Research Study Groups: Bipolar Disorder, Healthy Volunteers
Bipolar Disorder Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT04231643 — Phase < 1
Dronabinol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04231643 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research efforts have been undertaken with respect to Dronabinol?

"Currently, 19 trials for Dronabinol are in Phase 3 and 104 studies overall. While Belmont, Massachusetts is a hub of research activity on the compound, 331 sites across the world are currently conducting investigations into its efficacy."

Answered by AI

Does this research program accept elderly participants?

"Per the study's rules, enrolment requires that participants are aged between 18 and 50 years."

Answered by AI

Is joining this research endeavor open to me?

"The qualifications to join this clinical trial are manic disorder and being between 18-50 years old. It is expected that around 144 patients will be admitted into the study."

Answered by AI

Is participation in this clinical research endeavor still available?

"According to clinicaltrials.gov, this research has been ongoing since September 1st 2021 and is currently in search of patients. The most recent update was made on June 23rd 2022."

Answered by AI

What diseases have been alleviated with the application of Dronabinol?

"Dronabinol is largely implemented as a treatment of last resort due to its efficacy in treating multiple sclerosis, pharmacotherapy, and pain."

Answered by AI

To what extent can this research be conducted with test subjects?

"Affirmative, the information available on clinicaltrials.gov shows that this study is in its recruitment phase. It was initialy advertised on September 1st 2021 and recently revised on June 23rd 2022. The research team seeks to enrol 144 patients from a single healthcare centre."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Arizona
How old are they?
18 - 65
What site did they apply to?
UC San Diego Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I’m having such a hard time since 2010 not knowing this is what’s wrong with me and I have paranoia with it.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. UC San Diego Medical Center: < 24 hours
Average response time
  • < 1 Day
~40 spots leftby Apr 2025