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Understanding Cannabis Use and Depression in Young People with HIV
N/A
Recruiting
Led By Vilma Gabbay, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves MRI scans, there are minimal side effects expected. However, some individuals might feel discomfort due to the confined space of the scanner (claustrophobia) or loud noises during scanning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Addiction Severity Index (ASI)
Montgomery Asberg Depression Rating Scale (MADRS) Scale
Neural Circuitry measured by MRI
+1 moreSecondary study objectives
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Beck Depression Inventory-II (BDI-II)
Brief Pain Inventory (BPI)
+11 moreOther study objectives
3-item R-UCLA Loneliness Scale Range 3-9. Higher the lonelier a participant feels
Anxiety
Feeling suicidal (finding)
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PLWHExperimental Treatment1 Intervention
All participants will undergo neuroimaging and behavioral tests.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
955 Previous Clinical Trials
428,568 Total Patients Enrolled
31 Trials studying Depression
10,676 Patients Enrolled for Depression
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,535 Total Patients Enrolled
40 Trials studying Depression
62,627 Patients Enrolled for Depression
Albert Einstein College of MedicineLead Sponsor
296 Previous Clinical Trials
11,689,173 Total Patients Enrolled
8 Trials studying Depression
1,498 Patients Enrolled for Depression
Vilma Gabbay, MDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
520 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a unique pain condition like multiple sclerosis or rheumatoid arthritis.You may have thoughts of harming yourself, but if those thoughts become an immediate danger, you will be removed from the study and receive emergency medical attention.I use medical cannabis or plan to start using it.I do not have severe illnesses like advanced kidney, heart, liver disease, or another cancer.You can have anxiety disorders, OCD, and post-traumatic stress, but only if your main symptom is depression.I am between 18 and 34 years old.My depression score is 12 or higher on the MADRS scale.I can fluently speak English or Spanish.I have a brain condition or injury, or a disease that worsens over time.You have been diagnosed with bipolar disorder, psychotic disorders, or autism spectrum disorders. Additionally, if you have a history of substance abuse, except for cannabis, you will not be able to participate.You do not have any major psychiatric conditions except for cannabis use or disorder.
Research Study Groups:
This trial has the following groups:- Group 1: PLWH
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.