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Synthetic CBD 4-Week Trial Arm for Alexithymia (ACBD Trial)
Phase 2
Recruiting
Led By Erin E Morgan, 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
HIV+ and on stable ART
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
ACBD Trial Summary
This trial aims to investigate whether taking cannabidiol (CBD) can help people living with HIV and a condition called alexithymia to improve their emotional state and reduce inflammation. The researchers will
Who is the study for?
This trial is for adults aged 21-65 living with HIV/AIDS, on stable antiretroviral therapy (ART), who can consent and read/write in English. Participants must have clinically elevated alexithymia, which means they struggle to identify and describe their emotions.Check my eligibility
What is being tested?
The study tests if CBD can help people with HIV/AIDS improve their ability to understand and manage emotions by reducing alexithymia. It compares the effects of CBD against a placebo over four weeks, measuring emotional state changes and inflammation levels.See study design
What are the potential side effects?
While not explicitly stated here, common side effects of CBD may include tiredness, diarrhea, changes in appetite/weight. However, since it's being tested in a clinical setting, monitoring for any adverse reactions will be part of the study.
ACBD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HIV positive and on a stable antiretroviral therapy.
ACBD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Toronto Alexithymia Scale-20 Item Version
ACBD Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Synthetic CBD 4-Week Trial ArmActive Control1 Intervention
For one week they will titrate up to the maintenance dose of 600 mg/day of Purysis, a synthetic, liquid form of CBD, which they will continue for 4 weeks. Upon completion of the 4-week trial, they will be re-assessed, followed by one week of titrating down to discontinuation.
Group II: Placebo 4-Week Trial ArmPlacebo Group1 Intervention
For one week they will titrate up to the maintenance dose of 600 mg/day of placebo for Purysis, a synthetic, liquid form of CBD, which they will continue for 4 weeks. Upon completion of the 4-week trial, they will be re-assessed, followed by one week of titrating down to discontinuation.
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,122 Previous Clinical Trials
1,521,014 Total Patients Enrolled
Center for Medicinal Cannabis ResearchOTHER
18 Previous Clinical Trials
599 Total Patients Enrolled
California Department of Cannabis Control (DCC)UNKNOWN
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the 4-week trial segment involving synthetic CBD received approval from the FDA?
"Given that this trial is in Phase 2, our team at Power assigns a safety rating of 2 to the Synthetic CBD 4-Week Trial Arm. While there is limited data supporting its safety, no evidence has been found yet regarding its effectiveness."
Answered by AI
Are researchers currently enrolling participants for this study?
"Indeed, clinicaltrials.gov indicates that this ongoing clinical trial is actively seeking eligible candidates. The initial posting of the trial was on November 28th, 2023, and its most recent update occurred on January 23rd, 2024."
Answered by AI
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