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Role of CBD in Improving Alexithymia

NCT05832281 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-01-26

No results posted yet for this study

Summary

Given the treatments that are available today for HIV disease, people living with HIV (PLWH) can generally expect good medical outcomes. However, HIV is still a chronic disease and there are remaining barriers to achieving ideal health status and quality of life. One barrier may be a condition that is common among PLWH, called alexithymia, which can make it difficult for a person to name and describe the emotions that they are feeling. As a result, it is difficult to resolve negative emotional states, which can then lead to worse outcomes over time due to ongoing stress and related problems such as inflammation.

In this study the investigators will try to find out whether taking cannabidiol (CBD) helps PLWH who have alexithymia to resolve those negative emotional states, which may then reduce inflammation in the body as a result. CBD may work by enhancing the body's own chemical messengers that can help to regulate emotions and encourage emotional benefits. The investigators will compare a group of people who take CBD for 4 weeks to those who take a placebo, which is a substance that will closely resemble the CBD but will not contain any active drug. Study participants and the researchers who are working directly with the participants will not be able to tell which is the CBD and which is the placebo. The investigators will evaluate participants before and after the 4-week study period. They will also collect samples, such as blood, so that we can measure inflammation. The investigators will compare the two groups to see if those who took CBD have lower alexithymia and lower inflammation compared to those who took the placebo.

The potential benefit of this study is that CBD may be an effective treatment for alexithymia in PLWH, which may then improve both their emotional and physical health outcomes. This can help to address a remaining barrier to good medical outcomes for PLWH.

Conditions

  • Alexithymia
  • HIV

Interventions

DRUG

Purysis CBD

Participants will receive Purysis, or synthetic CBD, which will be compared to placebo

DRUG

Placebo

Placebo for Purysis

Sponsors & Collaborators

  • California Department of Cannabis Control (DCC)

    collaborator UNKNOWN

  • Center for Medicinal Cannabis Research

    collaborator OTHER

  • University of California, San Diego

    lead OTHER

Principal Investigators

  • Erin E Morgan, PhD · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2025-08-31
Completion
2025-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05832281 on ClinicalTrials.gov