Understanding Cannabis Use and Depression in Young People with HIV

Recruiting at 1 trial location

Overseen By Zoe Baker

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Psychotropics, Cocaine

Disqualifiers: Pregnancy, Severe illness, CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

280 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking any psychotropic medications (drugs that affect mood, perception, or behavior) for at least 1 month before joining the study, or 3 months for medications with longer half-lives. However, benzodiazepines and sleeping aids taken as needed are allowed, but you must stop them 4 days before any scans.

What data supports the effectiveness of this drug for young people with HIV and depression?

Research suggests that cannabis use in people with HIV may help normalize some brain function disruptions, such as improving brain network organization and reducing abnormal neural activity, which could potentially benefit cognitive function. ^{1 2 3 4 5}

Is cannabis use generally safe for people with HIV?

Research shows that cannabis use among people with HIV does not significantly affect important health markers like CD4 T-cell counts or body mass index, and it does not compromise adherence to antiretroviral therapy. However, cannabis use may be linked to a higher chance of having a detectable viral load, so it's important to discuss its use with a healthcare provider. ^{1 6 7 8 9}

How does cannabis use differ from other treatments for depression in young people with HIV?

Cannabis use in young people with HIV may uniquely affect brain function by potentially normalizing disruptions in brain network organization, which are often observed in individuals with HIV. This effect on brain connectivity is not typically seen with standard depression treatments, making cannabis a novel option for this specific population. ^{1 3 4 5 10}

What is the purpose of this trial?

This trial is studying how using cannabis and having depression together affect young people living with HIV. Researchers believe that these conditions combined might make it harder for them to feel pleasure and could increase their sensitivity to pain. The goal is to see if these effects lead to worse health outcomes over time.

Research Team

Vilma Gabbay, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for young adults aged 18-34 living with HIV in The Bronx, who experience depression and frequently use cannabis but do not have major psychiatric conditions like bipolar or psychotic disorders. Participants must be fluent in English or Spanish, able to consent, and have an IQ over 75. They should not have MRI contraindications like claustrophobia or metallic implants nor severe medical illnesses.

Inclusion Criteria

HIV seropositivity confirmed with lab report, medical records, or HIV testing

Cannabis users: Self-reported use on ≥20 of the prior 30 days and positive THC urine toxicology

Ability to provide informed consent and perform study procedures, including estimated full-scale IQ >75 to ensure understanding

Exclusion Criteria

Pregnancy or lactation

Perinatally acquired HIV infection

Current cocaine use by self-report or urine toxicology

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo neuroimaging and behavioral tests to establish baseline measures

1 week

1 visit (in-person)

Monitoring

Participants are monitored for changes in neural circuitry, depression, and cannabis use over time

12 months

Follow-up

Participants are monitored for safety and effectiveness after the main study period

4 weeks

Treatment Details

Interventions

• MRI study

Trial Overview The study aims to understand how cannabis use affects the brain's reward and pain responses in young adults with HIV. It involves MRI scans for all participants to observe neural activity related to substance abuse disorders and depression.

Participant Groups

Group I: PLWH Experimental Treatment 1 Intervention

All participants will undergo neuroimaging and behavioral tests.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study of 77 participants (48 HIV-positive and 29 HIV-negative), higher marijuana use was linked to smaller brain volumes in specific areas, but HIV status had a more significant impact on brain structure, particularly showing reduced cingulate thickness in HIV-positive individuals.

The interaction between HIV status and marijuana use affected cognitive performance, with HIV-negative individuals performing better than HIV-positive ones at lower levels of marijuana use, but this difference disappeared at higher usage levels (1.43g per week), indicating that marijuana use may mitigate cognitive differences between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marijuana effects on changes in brain structure and cognitive function among HIV+ and HIV- adults. Thames, AD., Kuhn, TP., Williamson, TJ., et al.[2019]

In a study involving 81 participants, including people with HIV (PWH) and controls, chronic cannabis use was linked to a significant reduction in abnormal pre-stimulus gamma activity in the visual cortices of PWH, suggesting a potential normalization of neural function.

Despite PWH showing behavioral deficits in visuospatial processing and altered neural oscillations, those who used cannabis exhibited improvements that brought their neural activity in line with non-using controls, indicating a possible beneficial effect of cannabis on cognitive function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis use impacts pre-stimulus neural activity in the visual cortices of people with HIV. Christopher-Hayes, NJ., Lew, BJ., Wiesman, AI., et al.[2022]

In a study of 78 adults, those with both HIV and marijuana use showed similar brain network organization to healthy controls, suggesting that marijuana may help normalize brain function disruptions caused by HIV.

In contrast, individuals with only HIV or only marijuana use exhibited significant disruptions in brain network organization, indicating that the effects of marijuana on cognition in HIV need further investigation to determine if they are beneficial or harmful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic effects of HIV and marijuana use on functional brain network organization. Hall, SA., Lalee, Z., Bell, RP., et al.[2022]

In a study of 93 adults, it was found that regular marijuana use and HIV infection both independently affect brain activation during cognitive tasks, particularly in regions like the inferior parietal lobules and anterior cingulate cortex.

The combination of HIV and marijuana use led to the most significant changes in brain activation, especially in the left fronto-insular cortex, suggesting that these factors together may complicate cognitive processing in affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synergistic effects of marijuana abuse and HIV infection on neural activation during a cognitive interference task. Meade, CS., Bell, RP., Towe, SL., et al.[2020]

In a study of 340 youth, both perinatally infected with HIV (PHIV+) and uninfected (PHIV-), marijuana use was found to predict the development of behavioral and mood disorders, highlighting a concerning link between substance use and mental health issues.

Interventions aimed at reducing early marijuana use could potentially lower the risk of developing psychiatric disorders, and addressing early behavioral disorders may help prevent subsequent marijuana use in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marijuana Use and Psychiatric Disorders in Perinatally HIV-Exposed Youth: Does HIV Matter? Elkington, KS., Cruz, JE., Warne, P., et al.[2018]

In a study of 1010 HIV-positive adults starting antiretroviral therapy, self-reported cannabis use did not show significant effects on CD4+ T-cell counts or body mass index (BMI).

However, cannabis use was linked to higher odds of having a detectable HIV-1 viral load, suggesting that it may impact viral control in HIV-positive individuals and warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported Cannabis Use and Changes in Body Mass Index, CD4 T-Cell Counts, and HIV-1 RNA Suppression in Treated Persons with HIV. Lee, JT., Saag, LA., Kipp, AM., et al.[2021]

In a study involving 523 HIV-positive illicit drug users, high-intensity cannabis use (at least daily) was not associated with adherence to antiretroviral therapy (ART), indicating that cannabis use may not negatively impact treatment compliance.

The research suggests that people living with HIV/AIDS can use cannabis for medicinal and recreational purposes without compromising their adherence to ART, which is crucial for managing their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity cannabis use and adherence to antiretroviral therapy among people who use illicit drugs in a Canadian setting. Slawson, G., Milloy, MJ., Balneaves, L., et al.[2022]

In a study of 397 people living with HIV, daily cannabis users reported more perceived benefits, such as relief from stress and improved sleep, while being less concerned about risks like addiction and legal issues compared to those who use cannabis less frequently.

Legalization of cannabis did not change the overall frequency of use among participants, but those in Colorado were more likely to view cannabis as beneficial for reducing other medications and less likely to see legal problems as a risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Risks and Benefits and Frequency of Cannabis Use Among People with HIV in Different Legal Environments. Laper, S., Hileman, CO., Block, G., et al.[2023]

In a study of 226 HIV-infected individuals, 38.5% reported current cannabis use, primarily for recreational purposes, with 21.8% using it for medicinal reasons, indicating a significant prevalence of cannabis consumption in this population.

Most cannabis users (80.5%) reported symptom relief, particularly for stress, anorexia, or pain, and the study found no association between cannabis use and adverse psychological outcomes, suggesting potential benefits without negative mental health effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and correlates of cannabis use among individuals with HIV/AIDS in Maritime Canada. Harris, GE., Dupuis, L., Mugford, GJ., et al.[2022]

In a study of 109 participants, those living with HIV showed impaired error-related brain activity, specifically a lack of deactivation in key brain regions, which was linked to poorer medication management abilities.

Chronic cannabis use among HIV-negative participants was associated with reduced brain activity related to error processing, suggesting that both HIV status and cannabis use can negatively impact behaviors crucial for health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV infection is linked with reduced error-related default mode network suppression and poorer medication management abilities. Flannery, JS., Riedel, MC., Salo, T., et al.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Marijuana effects on changes in brain structure and cognitive function among HIV+ and HIV- adults. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Cannabis use impacts pre-stimulus neural activity in the visual cortices of people with HIV. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Synergistic effects of HIV and marijuana use on functional brain network organization. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Synergistic effects of marijuana abuse and HIV infection on neural activation during a cognitive interference task. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Marijuana Use and Psychiatric Disorders in Perinatally HIV-Exposed Youth: Does HIV Matter? [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Self-reported Cannabis Use and Changes in Body Mass Index, CD4 T-Cell Counts, and HIV-1 RNA Suppression in Treated Persons with HIV. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

High-intensity cannabis use and adherence to antiretroviral therapy among people who use illicit drugs in a Canadian setting. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Perceived Risks and Benefits and Frequency of Cannabis Use Among People with HIV in Different Legal Environments. [2023]

9. Egypt pubmed.ncbi.nlm.nih.gov

Patterns and correlates of cannabis use among individuals with HIV/AIDS in Maritime Canada. [2022]

10. England pubmed.ncbi.nlm.nih.gov

HIV infection is linked with reduced error-related default mode network suppression and poorer medication management abilities. [2022]