HIV-1-infectionEarly Phase 1NCT04883255
Cannabis Use, Cognition, and the Endocannabinoid System in HIV
A Early Phase 1 study testing 10 mg Δ9-tetrahydrocannabinol (THC) and 600 mg cannabidiol (CBD) in people with HIV-1-infection, run by University of California, San Diego at 1 site in United States.
Trial summary
Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- 10 mg Δ9-tetrahydrocannabinol (THC) and 600 mg cannabidiol (CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2023to 30 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-65
- Possess the capacity to provide informed consent to a set of neurobehavioral, neuromedical and cognitive assessment procedures. Individuals unable to provide such consent will not be enrolled into the study.
- Willing to confirm self-reported HIV using a rapid test: HIV status will be determined using the MedMira Rapid Test (Halifax, Nova Scotia, Canada). If the result differs from the participant's self-report a confirmatory Western Blot will be performed.
- Willing to abstain from cannabis for at least 1 week prior to the baseline visit and during the study. Although there is no definitive method for determining abstinence over this period, abstinence will be confirmed as best as possible by using an oral fluid testing device (Draeger 5000) employed by law enforcement officers to detect recent cannabis use. An oral fluid value of > 5ng suggests recent use, although in some cases it has been reported that individuals may show > 5ng up to 20 hours after use. Thus, should the oral fluid sample indicate > 5ng THC, the assessment may be canceled and rescheduled.
Who cannot join
- Inability to provide informed consent
- Significant chronic renal disease (unrelated to HIV), significant chronic pulmonary disease (unrelated to HIV), or Hepatitis C Virus infection
- Head injury with loss of consciousness for greater than 30 minutes or resulting in neurologic complications
- Seizure disorder
- Demyelinating diseases or other non-HIV neurological disorders
- Pregnancy
Show all 10Show fewer
- Acute or recent or previous clinically disabling stroke or previous cerebrovascular events
- Lifetime history of schizophrenia or other psychotic disorders, or bipolar disorder.
- Beck Depression Inventory-II (BDI-II) score is greater than or equal to 29 (severe depression) or suicidal ideas are endorsed on the BDI-II or a Center for Epidemiological Studies-Depression Scale (CES-D) subscale measuring suicidal ideation
- Substance use disorder (mild, moderate or severe) within the last 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Medical Center-Hillcrest
San Diego, California, 92103-8620
About this study
Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreationally, may indicate disease severity, impart therapeutic benefits, or adverse consequences. In fact, cannabis is recommended to those with HIV to alleviate nausea, improve appetite, relieve pain, and lift mood. To-date, the consequences of cannabis use in PWH remain unclear as do potential interactions with HIV treatments. In healthy participants, heavy cannabis use is associated with cognitive deficits e.g., risky decision-making, response disinhibition and inattention, but pro-cognitive effects in PWH may exist at mild use levels due to its anti-inflammatory and anti-excitotoxic properties. Furthermore, little has been done to determine the effects of cannabis use on the endocannabinoid (EC) system in general or in PWH. This study will determine the effects of the two primary cannabis constituents (Δ9-tetrahydrocannabinol [THC], cannabidiol [CBD]) vs. placebo on risky decision-making, response inhibition, reward learning, temporal perception, and motivation, plus EC and homovanillic acid (HVA; a surrogate for dopamine activity) levels in HIV+ and HIV- subjects. Participants with infrequent cannabis use will undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified. They will be randomized to a 5-day course of either THC, CBD, or placebo and return for follow-up testing and re-assaying of ECs and HVA levels.
- Conditions
- HIV-1-infection
- Being tested
- 10 mg Δ9-tetrahydrocannabinol (THC), 600 mg cannabidiol (CBD), Placebo
- Keywords
- cannabis, HIV, THC, cannabidiol
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 mg Δ9-tetrahydrocannabinol (THC)Drug
5-day course of orally-administered THC (dronabinol), 10 mg
600 mg cannabidiol (CBD)Drug
5-day course of orally-administered CBD, 600 mg
PlaceboDrug
5-day course of orally-administered placebo
| Study group | Role | What they receive |
|---|---|---|
| HIV-positive subjects | Experimental | Adult human subjects seropositive for HIV-1 Receives: Drug: 10 mg Δ9-tetrahydrocannabinol (THC); Drug: 600 mg cannabidiol (CBD); Drug: Placebo |
| Healthy Comparison Volunteers | Active comparator | Adult human subjects without HIV Receives: Drug: 10 mg Δ9-tetrahydrocannabinol (THC); Drug: 600 mg cannabidiol (CBD); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Iowa Gambling Task score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect increased risk-taking
Measured: baseline and 5 days after drug initiation
change in Human Temporal Bisection Task score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Scores reflect fast or slow perception of timing.
Measured: baseline and 5 days after drug initiation
change in Probabilistic Learning Task score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect poorer learning.
Measured: baseline and 5 days after drug initiation
change in Progressive Ratio Task score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect lower motivation or willingness to work for a reward.
Measured: baseline and 5 days after drug initiation
change in Continuous Performance Task score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect worse attention.
Measured: baseline and 5 days after drug initiation
change in human Behavioral Pattern Monitor activity and exploration score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Higher scores reflect motor hyperactivity and increased exploration.
Measured: baseline and 5 days after drug initiation
change in prepulse inhibition percentage score from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect worse sensorimotor gating.
Measured: baseline and 5 days after drug initiation
change in cerebrospinal fluid (CSF) anandamide (AEA) quantity from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower AEA signifies less amounts of this endocannabinoid in the central nervous system.
Measured: baseline and 5 days after drug initiation
change in cerebrospinal fluid (CSF) 2-Arachidonoylglycerol (2-AG) quantity from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower 2-AG signifies less amounts of this endocannabinoid in the central nervous system.
Measured: baseline and 5 days after drug initiation
change in cerebrospinal fluid (CSF) homovanillic acid (HVA) quantity from baseline to post-intervention
This is an experimental measure and not a scale with specific anchor points. Lower HVA signifies less amounts of this dopamine metabolite in the central nervous system.
Measured: baseline and 5 days after drug initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start3 May 2023
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Arpi Minassian, University of California, San Diego
- Investigators
- Arpi Minassian, Ph.D., Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883255
- Sponsor's protocol ID
- 210323
- Other IDs
- R01DA051295
- Status last verified
- Oct 2026
- First submitted
- 3 May 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Use, Cognition, and the Endocannabinoid System in HIV
- ClinicalTrials.gov ID
- NCT04883255
- Acronym / sponsor ID
- 210323
- Conditions
- HIV-1-infection
- Keywords
- cannabis, HIV, THC, cannabidiol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 May 2023 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Understanding how co-morbidities in persons with HIV (PWH) such as substance use affect risk-taking, decision-making, and other cognitive behaviors is important given implications for everyday functioning and transmission risk. The high prevalence of cannabis use in PWH, medicinally and recreationally, may indicate disease severity, impart therapeutic benefits, or adverse consequences. In fact, cannabis is recommended to those with HIV to alleviate nausea, improve appetite, relieve pain, and lift mood. To-date, the consequences of cannabis use in PWH remain unclear as do potential interactions with HIV treatments. In healthy participants, heavy cannabis use is associated with cognitive deficits e.g., risky decision-making, response disinhibition and inattention, but pro-cognitive effects in PWH may exist at mild use levels due to its anti-inflammatory and anti-excitotoxic properties. Furthermore, little has been done to determine the effects of cannabis use on the endocannabinoid (EC) system in general or in PWH. This study will determine the effects of the two primary cannabis constituents (Δ9-tetrahydrocannabinol [THC], cannabidiol [CBD]) vs. placebo on risky decision-making, response inhibition, reward learning, temporal perception, and motivation, plus EC and homovanillic acid (HVA; a surrogate for dopamine activity) levels in HIV+ and HIV- subjects. Participants with infrequent cannabis use will undergo baseline cognitive testing and biomarker assays with antiretrovirals (ART) use quantified. They will be randomized to a 5-day course of either THC, CBD, or placebo and return for follow-up testing and re-assaying of ECs and HVA levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-positive subjects | Experimental | Drug: 10 mg Δ9-tetrahydrocannabinol (THC), Drug: 600 mg cannabidiol (CBD), Drug: PlaceboAdult human subjects seropositive for HIV-1 |
| Healthy Comparison Volunteers | Active comparator | Drug: 10 mg Δ9-tetrahydrocannabinol (THC), Drug: 600 mg cannabidiol (CBD), Drug: PlaceboAdult human subjects without HIV |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-65
- Possess the capacity to provide informed consent to a set of neurobehavioral, neuromedical and cognitive assessment procedures. Individuals unable to provide such consent will not be enrolled into the study.
- Willing to confirm self-reported HIV using a rapid test: HIV status will be determined using the MedMira Rapid Test (Halifax, Nova Scotia, Canada). If the result differs from the participant's self-report a confirmatory Western Blot will be performed.
- Willing to abstain from cannabis for at least 1 week prior to the baseline visit and during the study. Although there is no definitive method for determining abstinence over this period, abstinence will be confirmed as best as possible by using an oral fluid testing device (Draeger 5000) employed by law enforcement officers to detect recent cannabis use. An oral fluid value of > 5ng suggests recent use, although in some cases it has been reported that individuals may show > 5ng up to 20 hours after use. Thus, should the oral fluid sample indicate > 5ng THC, the assessment may be canceled and rescheduled.
Key exclusion criteria (10 listed)
- Inability to provide informed consent
- Significant chronic renal disease (unrelated to HIV), significant chronic pulmonary disease (unrelated to HIV), or Hepatitis C Virus infection
- Head injury with loss of consciousness for greater than 30 minutes or resulting in neurologic complications
- Seizure disorder
- Demyelinating diseases or other non-HIV neurological disorders
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 |
|---|---|---|
| 10 mg Δ9-tetrahydrocannabinol (THC)5-day course of orally-administered THC (dronabinol), 10 mg | Drug | HIV-positive subjects, Healthy Comparison Volunteers |
| 600 mg cannabidiol (CBD)5-day course of orally-administered CBD, 600 mg | Drug | HIV-positive subjects, Healthy Comparison Volunteers |
| Placebo5-day course of orally-administered placebo | Drug | HIV-positive subjects, Healthy Comparison Volunteers |
Primary outcome
change in Iowa Gambling Task score from baseline to post-intervention
Time frame: baseline and 5 days after drug initiation
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect increased risk-taking
change in Human Temporal Bisection Task score from baseline to post-intervention
Time frame: baseline and 5 days after drug initiation
This is an experimental measure and not a scale with specific anchor points. Scores reflect fast or slow perception of timing.
change in Probabilistic Learning Task score from baseline to post-intervention
Time frame: baseline and 5 days after drug initiation
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect poorer learning.
change in Progressive Ratio Task score from baseline to post-intervention
Time frame: baseline and 5 days after drug initiation
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect lower motivation or willingness to work for a reward.
change in Continuous Performance Task score from baseline to post-intervention
Time frame: baseline and 5 days after drug initiation
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect worse attention.
change in human Behavioral Pattern Monitor activity and exploration score from baseline to post-intervention
Time frame: baseline and 5 days after drug initiation
This is an experimental measure and not a scale with specific anchor points. Higher scores reflect motor hyperactivity and increased exploration.
change in prepulse inhibition percentage score from baseline to post-intervention
Time frame: baseline and 5 days after drug initiation
This is an experimental measure and not a scale with specific anchor points. Lower scores reflect worse sensorimotor gating.
change in cerebrospinal fluid (CSF) anandamide (AEA) quantity from baseline to post-intervention
Time frame: baseline and 5 days after drug initiation
This is an experimental measure and not a scale with specific anchor points. Lower AEA signifies less amounts of this endocannabinoid in the central nervous system.
change in cerebrospinal fluid (CSF) 2-Arachidonoylglycerol (2-AG) quantity from baseline to post-intervention
Time frame: baseline and 5 days after drug initiation
This is an experimental measure and not a scale with specific anchor points. Lower 2-AG signifies less amounts of this endocannabinoid in the central nervous system.
change in cerebrospinal fluid (CSF) homovanillic acid (HVA) quantity from baseline to post-intervention
Time frame: baseline and 5 days after drug initiation
This is an experimental measure and not a scale with specific anchor points. Lower HVA signifies less amounts of this dopamine metabolite in the central nervous system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Arpi Minassian, Ph.D. principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 10 mg Δ9-tetrahydrocannabinol (THC) and 600 mg cannabidiol (CBD) in people with HIV-1-infection, 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 3 Nov 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in Iowa Gambling Task score from baseline to post-intervention (time frame: baseline and 5 days after drug initiation). The study lists 10 primary outcomes in all. 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 3 Nov 2026.