Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04883255

Cannabis Use, Cognition, and the Endocannabinoid System in HIV

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HIV-1-infection Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UC San Diego Medical Center-Hillcrest

San Diego, California, 92103-8620, United States

Location status: Recruiting

Location contact

Arpi Minassian, PhD

CONTACT

[email protected]

6195433422

Roberto Gallardo

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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

Placebo

Drug

5-day course of orally-administered placebo

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Crossby Vargas

CONTACT

[email protected]

619-543-5000

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 12, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.