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Cannabis Use, Cognition, and the Endocannabinoid System in HIV

Primary Purpose

HIV-1-infection

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

10 mg Δ9-tetrahydrocannabinol (THC)

600 mg cannabidiol (CBD)

Placebo

About this trial

This is an interventional basic science trial for HIV-1-infection focused on measuring cannabis, HIV, THC, cannabidiol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

Aged 18 and older
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.
HIV Status: 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.
Infrequent use of cannabis, defined as 1-4 times per month. Must have used cannabis at least five times in the past two years without an adverse reaction.
Willing to abstain from cannabis for at least 2 days prior the baseline visit. 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
Alcohol use disorder (moderate or severe) within the last 12 months
For other substances besides alcohol and cannabis, moderate or severe substance use disorder within the past five years or a mild substance use disorder within the past 12 months.

Sites / Locations

UC San Diego Medical Center-HillcrestRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIV-positive subjects

Healthy Comparison Volunteers

Arm Description

Adult human subjects seropositive for HIV-1

Adult human subjects without HIV

Outcomes

Primary Outcome Measures

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04883255

First Posted

May 3, 2021

Last Updated

June 13, 2023

Sponsor

University of California, San Diego

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT04883255

Brief Title

Cannabis Use, Cognition, and the Endocannabinoid System in HIV

Official Title

Cannabis Use, Cognition, and the Endocannabinoid System in HIV

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 3, 2023 (Actual)

Primary Completion Date

January 31, 2026 (Anticipated)

Study Completion Date

January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-1-infection

Keywords

cannabis, HIV, THC, cannabidiol

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIV-positive subjects

Arm Type

Experimental

Arm Description

Adult human subjects seropositive for HIV-1

Arm Title

Healthy Comparison Volunteers

Arm Type

Active Comparator

Arm Description

Adult human subjects without HIV

Intervention Type

Drug

Intervention Name(s)

10 mg Δ9-tetrahydrocannabinol (THC)

Intervention Description

5-day course of orally-administered THC (dronabinol), 10 mg

Intervention Type

Drug

Intervention Name(s)

600 mg cannabidiol (CBD)

Intervention Description

5-day course of orally-administered CBD, 600 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

5-day course of orally-administered placebo

Primary Outcome Measure Information:

Title

change in Iowa Gambling Task score from baseline to post-intervention

Description

This is an experimental measure and not a scale with specific anchor points. Lower scores reflect increased risk-taking

Time Frame