Role of CBD in Improving Alexithymia

NCT05832281 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 804507
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Toronto Alexithymia Scale-20 Item Version

  Range of scores: 20 to 100 (Higher scores reflect greater challenges or impairment)

  4 weeks

Study Arms (2)

Synthetic CBD 4-Week Trial Arm

ACTIVE COMPARATOR

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.

Drug: Purysis CBD

Placebo 4-Week Trial Arm

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Purysis CBD DRUG

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

Also known as: Synthetic CBD

Synthetic CBD 4-Week Trial Arm

Placebo DRUG

Placebo for Purysis

Also known as: Purysis Placebo

Placebo 4-Week Trial Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+ and on stable ART
• 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
• possess the ability to provide consent
• possess the ability to read and write in English (given that translations are not available for all tests)
• screen positive for clinically elevated alexithymia.

You may not qualify if:

• 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
• 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
• 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)
• current cannabis use in the last 3 months given that it may confound the effect of the study drug and alter AEA levels
• pregnancy

Sponsors & Collaborators

• University of California, San Diego: lead
• California Department of Cannabis Control (DCC): collaborator
• Center for Medicinal Cannabis Research: collaborator

Study Sites (1)

HIV Neurobehavioral Research Center/Center for Medicinal Cannabis Research

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Affective Symptoms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Erin E Morgan, PhD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: Double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 27, 2023
• Study Start: November 28, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)