Using CBD to help people with HIV and alexithymia
The Role of Cannabidiol in Anandamide-Related Improvement in Alexithymia and Health Outcomes
This study is testing if CBD can help people with HIV who struggle to understand their emotions feel better and improve their overall health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05832281 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of cannabidiol (CBD) on individuals living with HIV who experience alexithymia, a condition that impairs emotional awareness. The study aims to determine if CBD can help alleviate negative emotional states associated with alexithymia, potentially leading to improved health outcomes and reduced inflammation. It is a phase II, double-blind, placebo-controlled trial enrolling 15 participants who are HIV-positive and on stable antiretroviral therapy. The trial will assess the impact of CBD on emotional regulation and overall health-related quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21-65 who are HIV-positive, on stable antiretroviral therapy, and exhibit clinically elevated alexithymia.
Not a fit: Patients with a history of psychosis, bipolar disorder, or significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic approach to improve emotional well-being and health outcomes for people living with HIV.
How similar studies have performed: While prior studies have shown that behavioral interventions can improve alexithymia, pharmacological approaches like this one using CBD are less explored and may represent a novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. HIV+ and on stable ART 2. adults aged 21-65, due to the inherent complication of providing a cannabis product to individuals under the legal age for cannabis use (i.e., 21 years of age) and the potential for greater sensitivity to CBD in older individuals 3. possess the ability to provide consent 4. possess the ability to read and write in English (given that translations are not available for all tests) 5. screen positive for clinically elevated alexithymia. Exclusion Criteria: 1. history of psychosis, bipolar disorder, or substance use disorder within 6 months (irregular drug/alcohol use not meeting criteria for a substance use disorder will not be exclusionary) 2. history of a significant neurological condition that might affect the central nervous system (e.g., severe head trauma with loss of consciousness, epilepsy) other than HIV 3. current psychiatric treatment or symptoms (i.e., severe distress and/or active suicidality) that may confound results or introduce risk as determined by the PI or study physician 4. medical contraindication for CBD treatment as determined by the study physician's review of potential participants' medical screen and bloodwork, (e.g., cardiovascular, hepatic or renal disease) 5. current cannabis use in the last 3 months given that it may confound the effect of the study drug and alter AEA levels 6. pregnancy
Where this trial is running
San Diego, California
- HIV Neurobehavioral Research Center/Center for Medicinal Cannabis Research — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Erin E Morgan, PhD — UCSD
- Study coordinator: Roberto Gallardo
- Email: hnrprecruitment@ucsd.edu
- Phone: 619-543-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.