TERMINATED

Role of CBD in Improving Alexithymia

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Role of Cannabidiol in Anandamide-Related Improvement in Alexithymia and Health Outcomes

Quick Facts

Study Start:2023-11-28
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05832281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. HIV+ and on stable ART
  2. 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. 3. possess the ability to provide consent
  4. 4. possess the ability to read and write in English (given that translations are not available for all tests)
  5. 5. screen positive for clinically elevated alexithymia.
  1. 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. 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. 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. 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. 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. 6. pregnancy

Contacts and Locations

Principal Investigator

Erin E Morgan, PhD
PRINCIPAL_INVESTIGATOR
UCSD

Study Locations (Sites)

HIV Neurobehavioral Research Center/Center for Medicinal Cannabis Research
San Diego, California, 92103
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Erin E Morgan, PhD, PRINCIPAL_INVESTIGATOR, UCSD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-28
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-11-28
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Alexithymia
  • HIV