AlexithymiaPhase 2ACBDNCT05832281
Role of CBD in Improving Alexithymia
A Phase 2 study testing Purysis CBD in people with Alexithymia and HIV, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Alexithymia, HIV
- What is being tested?
- Purysis CBD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
HIV Neurobehavioral Research Center/Center for Medicinal Cannabis Research
San Diego, California, 92103
About this study
Official title: The Role of Cannabidiol in Anandamide-Related Improvement in Alexithymia and Health Outcomes
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.
Read the detailed description
Although HIV disease can be medically well-managed, the chronicity of the disease nevertheless takes a toll on persistent inflammation, comorbid medical and mental health conditions, and poor psychosocial functioning. Therefore, it is necessary to identify barriers to optimal health-related outcomes and quality of life. One such barrier may be alexithymia, which is poor internal emotional awareness that is elevated in the context of many chronic conditions, including HIV. Subsequent persistent dysregulation of negative emotional states and stress has been linked to worse HIV disease progression and management, and poor psychosocial functioning. The present study will evaluate whether treatment with cannabidiol (CBD) will reduce or compensate for elevated alexithymia among people living with HIV (PLWH), and whether targeting alexithymia with CBD treatment twill be associated with improved health-related outcomes in this population. Prior studies suggest that alexithymia can indeed be improved with behavioral intervention, with subsequent benefits for health outcomes. Limited evidence is available for pharmacological intervention. CBD may be a useful therapeutic tool due to its proposed role in enhancing circulating anandamide (AEA), an endogenous cannabinoid associated with social-emotional benefits.
The proposed study is a phase II, double-blind, placebo-controlled clinical trial of CBD for alexithymia and health-related outcomes. The study will enroll 15 HIV+ individuals in each treatment arm (drug vs placebo), and participants will be eligible for the study if they screen positive for elevated alexithymia and are not current cannabis users. They will be evaluated at two time points, five weeks apart, to compare the study outcomes pre- and post-treatment. 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. The pre- and post-treatment assessments will measure alexithymia and health-related outcomes, and samples will be collected (i.e., plasma, cerebrospinal fluid) to measure central and peripheral levels of AEA.
With this approach the investigators will test our hypothesis that treatment with CBD will decrease alexithymia, which will be associated with better organic disease outcomes (e.g., lower inflammation), reduced physical and mental health symptom reporting, and improvement in maladaptive behaviors (e.g., psychosocial functioning). The investigators will also determine whether AEA is indeed associated with alexithymia, and investigate the possibility that CBD reduces alexithymia via increasing circulating AEA.
- Conditions
- Alexithymia, HIV
- Being tested
- Purysis CBD, Placebo
- Medical subject headings
- Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purysis CBDDrug
Also called Synthetic CBD
Participants will receive Purysis, or synthetic CBD, which will be compared to placebo
PlaceboDrug
Also called Purysis Placebo
Placebo for Purysis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Alexithymia Scale-20 Item Version
Range of scores: 20 to 100 (Higher scores reflect greater challenges or impairment)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start12 Mar 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Why it stopped: Original funding period ended and a no-cost extension was not granted. Without funding to continue, the study was stopped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AlexithymiaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- California Department of Cannabis Control (DCC), Center for Medicinal Cannabis Research
- Responsible party
- Principal investigator, Erin Morgan, University of California, San Diego
- Investigators
- Erin E Morgan, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832281
- Sponsor's protocol ID
- 804507
- Acronym
- ACBD
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2023
- Last updated
- 1 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cannabidiol in Anandamide-Related Improvement in Alexithymia and Health Outcomes
- ClinicalTrials.gov ID
- NCT05832281
- Acronym / sponsor ID
- ACBD / 804507
- Conditions
- Alexithymia, HIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original funding period ended and a no-cost extension was not granted. Without funding to continue, the study was stopped.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- California Department of Cannabis Control (DCC), Center for Medicinal Cannabis Research
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Posted 1 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although HIV disease can be medically well-managed, the chronicity of the disease nevertheless takes a toll on persistent inflammation, comorbid medical and mental health conditions, and poor psychosocial functioning. Therefore, it is necessary to identify barriers to optimal health-related outcomes and quality of life. One such barrier may be alexithymia, which is poor internal emotional awareness that is elevated in the context of many chronic conditions, including HIV. Subsequent persistent dysregulation of negative emotional states and stress has been linked to worse HIV disease progression and management, and poor psychosocial functioning. The present study will evaluate whether treatment with cannabidiol (CBD) will reduce or compensate for elevated alexithymia among people living with HIV (PLWH), and whether targeting alexithymia with CBD treatment twill be associated with improved health-related outcomes in this population. Prior studies suggest that alexithymia can indeed be improved with behavioral intervention, with subsequent benefits for health outcomes. Limited evidence is available for pharmacological intervention. CBD may be a useful therapeutic tool due to its proposed role in enhancing circulating anandamide (AEA), an endogenous cannabinoid associated with social-emotional benefits.
The proposed study is a phase II, double-blind, placebo-controlled clinical trial of CBD for alexithymia and health-related outcomes. The study will enroll 15 HIV+ individuals in each treatment arm (drug vs placebo), and participants will be eligible for the study if they screen positive for elevated alexithymia and are not current cannabis users. They will be evaluated at two time points, five weeks apart, to compare the study outcomes pre- and post-treatment. 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. The pre- and post-treatment assessments will measure alexithymia and health-related outcomes, and samples will be collected (i.e., plasma, cerebrospinal fluid) to measure central and peripheral levels of AEA.
With this approach the investigators will test our hypothesis that treatment with CBD will decrease alexithymia, which will be associated with better organic disease outcomes (e.g., lower inflammation), reduced physical and mental health symptom reporting, and improvement in maladaptive behaviors (e.g., psychosocial functioning). The investigators will also determine whether AEA is indeed associated with alexithymia, and investigate the possibility that CBD reduces alexithymia via increasing circulating AEA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Synthetic CBD 4-Week Trial Arm | Active comparator | Drug: Purysis CBDFor 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. |
| Placebo 4-Week Trial Arm | Placebo comparator | Drug: PlaceboFor 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purysis CBDAlso: Synthetic CBDParticipants will receive Purysis, or synthetic CBD, which will be compared to placebo | Drug | Synthetic CBD 4-Week Trial Arm |
| PlaceboAlso: Purysis PlaceboPlacebo for Purysis | Drug | Placebo 4-Week Trial Arm |
Primary outcome
Toronto Alexithymia Scale-20 Item Version
Time frame: 4 weeks
Range of scores: 20 to 100 (Higher scores reflect greater challenges or impairment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin E Morgan, PhD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Purysis CBD in people with Alexithymia and HIV, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Alexithymia Scale-20 Item Version (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.