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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the interaction between cannabis use and depression in young people living with HIV. Researchers seek to understand how these factors might affect the brain's reward and pain systems, potentially leading to worse health outcomes over time. Participants will undergo MRI scans and behavioral tests to gather insights. Individuals with HIV who frequently use cannabis and experience depression might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding complex health interactions and potentially improve future treatments.

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 prior data suggests that this MRI study is safe for participants?

Research has shown that MRI, a scan that uses magnets and radio waves to take pictures of the inside of the body, is generally safe. No harmful effects from the magnetic fields or radio waves used in MRI have been identified. People have undergone MRIs for many years without serious problems. Some individuals might feel uncomfortable in the small space of the machine, but this is usually manageable.

In this study, the MRI examines how cannabis (marijuana) use and depression affect the brain in people living with HIV. No other treatments are being tested, so the focus remains on the MRI procedure itself. Overall, this type of brain imaging is well-tolerated and has been safely used in many research studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses MRI technology to explore the brain's response to cannabis use in young people with HIV who experience depression. Unlike traditional treatments for depression, which often focus on medication or therapy, this study aims to uncover the neural underpinnings of depression through advanced imaging techniques. By identifying specific brain patterns associated with cannabis use and depression, researchers hope to open new avenues for targeted treatments that could be more effective and personalized.

What evidence suggests that this MRI study is effective for understanding cannabis use and depression in young people with HIV?

Research has shown that cannabis use can change brain function in people living with HIV (PLWH), particularly in areas related to pleasure and pain. Studies have found that cannabis might alter how the brain processes these sensations, which is crucial for understanding depression. Cannabis use can sometimes reduce pain, but it might also diminish enjoyment of everyday activities. This combination suggests that cannabis use alongside depression could worsen mental health over time. The trial will explore these effects by having all participants undergo neuroimaging and behavioral tests over 12 months. Understanding these brain changes could aid in developing better treatments for depression and substance use in PLWH.

Who Is on the Research Team?

Vilma Gabbay, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Neural Underpinnings of Depression Group Experimental Treatment 1 Intervention

All participants will undergo neuroimaging and behavioral tests. during the course of the study (12 months).

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+

Published Research Related to This Trial

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 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 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 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 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 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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05453513?tab=history&a=6

Record History | ver. 6: 2023-07-13 | NCT05453513 The focus is on young adults (ages 18-34) to minimize HIV chronicity effects and due to the high rates of SUD and reduced adherence to HIV treatments in this ...

2. withpower.com withpower.com/trial/phase-marijuana-abuse-5-2022-d62ec

Understanding Cannabis Use and Depression in Young ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7680275/

Reciprocal Influences of HIV and Cannabinoids on the Brain ... This review summarizes existing research on how early and chronic cannabis use might render individuals more vulnerable to HIV-associated neuropathology, and ...

4. ahajournals.org ahajournals.org/doi/10.1161/STR.0000000000000396

Use of Marijuana: Effect on Brain Health This scientific statement reviews the safety of cannabis use from the perspective of brain health, describes mechanistically how cannabis may cause cognitive ...

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1505440/full

Neurological impact of HIV/AIDS and substance use alters ... This review aims to highlight the comorbid effects of HIV and substance use in specific brain regions and cell types involved in the persistence of HANDs.