Consequences of Marijuana Use in HIV-infected Youth

Consequences of Marijuana Use on Inflammatory Pathways in HIV-Infected Youth

Proposed study focuses on Youth With HIV (YWH) recruited from the University of North Carolina using a cross sectional assessment of blood samples, clinical, demographic, behavioral, [including substance use and frequency], and neurocognitive data will be evaluated from YWH treated before CD4 T cell decline.

Study Overview

• Status: Active, not recruiting
• Conditions: Youth With HIV

Detailed Description

The long-term goal for the proposed research is to apply a systems biology approach to discover evidence that provides the basis for understanding the complex and at times conflicting roles for marijuana in chronic inflammation in HIV-infected youth. To achieve the goal, a systems biology approach with two aims is designed:

Aim 1. To identify inflammatory immune pathways perturbed by recreational marijuana with or without concomitant use of tobacco products by applying a deep sequencing approach to define global transcriptome of peripheral blood cells from HIV-infected virally suppressed youth.

Aim 2. To develop biomarker profiles associated with pro- or anti-inflammatory pathways perturbed by marijuana and to discover biomarker profiles linked to neurocognitive impairment that are impacted by marijuana and tobacco use by YWH

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Enrollment will consist of approximately 61 HIV-infected youth meeting the below entry criteria who are receiving antiretroviral therapy with undetectable viral levels at the time of entry (based on viral load assay within 1 year of enrollment) Recruitment will include Youth Age 21-28

• Youth who use marijuana only [targeted number 20 participants]
• Youth who use tobacco products only [targeted number 24 participants]
• Youth who use marijuana and tobacco [targeted number 7 participants]
• Youth who do not use substances [targeted number 10 participants]

Description

Inclusion Criteria:

• Age 21 years 0 days - less than28 years 364 days
• Currently treated with stable ART and no ART changes for >6months.
• Willingness to participate in CASI questionnaire of self-reported substance use
• Documented behavioral transmission of HIV infection based on CLIA approved HIV antibody/antigen based testing method in medical record -HIV diagnosis greater than or equal to years. Viral load LESS THAN 50 COPIES/ML for the past 6 months. --

Patients may have had single blips in viral load to greater than 50 but less than 1000 copies/ml within the year prior to screening.

• Current Substance profile by chart review or phone screening:
• Marijuana use defined as marijuana use by any route at least 3 times per week in the absence of tobacco. N= 20.
• Tobacco use only based on report of regular (at least 3 times per week smoking). N=24
• Tobacco plus marijuana use defined as regular smoking and marijuana (at least 3 times per week) N =7
• No substance use of any type (alcohol, tobacco, marijuana or other recreational drugs in the past 90 days). N = 10
• Able to provide written informed consent in English and to adhere to protocol schedule

Exclusion Criteria:

• History of AIDS defining illness
• Pregnancy at any time during the study
• Use of substances that would interfere with the ability to complete the study
• History of significant cognitive or motor impairment or other chronic condition that would interfere with the ability to complete the study and impact neurocognitive testing
• Acute psychiatric symptoms (e.g. suicidality, mania, psychosis or severe depression)
• Other neurological disorder (e.g. multiple sclerosis, seizure disorder, etc.) requiring ongoing treatment or active outpatient evaluation
• Severe mental illness (requiring antipsychotic or mood stabilizing medications and/or inpatient hospitalization in past year)
• History of CNS infection (AIDS opportunistic (e.g. toxoplasmosis) or non-opportunistic (bacterial meningitis) with lasting or permanent neurological sequelae)
• Underlying and/or uncontrolled medical illnesses that may result in chronic inflammation , (e.g. SLE or autoimmune disease) as determined by the PI
• Nursing mothers
• Unable to read and write in English

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
HIV infected youth who use marijuana only
HIV infected youth who use tobacco only
HIV infected youth who use tobacco and marijuana
HIV infected youth with no substance use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of bio-marker pathways that are abnormal.	This is measured by molecular mechanism of chronic macrophage activation.	24 months
Plasma levels of sCD163	Chi-square test will be used to compare discrete variables	24 months
Neurocognitive function as measured by Trial Making Test (TMT)		24 months
Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate)		24 months
Neurocognitive function as measured by Hopkins Verbal Learning Test-R		24 months
Neurocognitive function as measured by the Brief Visuospatial Memory Test-R		24 months
Neurocognitive function as measured by the WRAT-4 Word Reading subtest		24 months
Neurocognitive function as measured by Activities of Daily Living Questionnaire		24 months
Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning		24 months
Neurocognitive function as measured by Grooved Pegboard test		24 months
Neurocognitive function as measured by Timed Gait Test		24 months
Neurocognitive function as measured by Verbal Fluency Test		24 Months
Neurocognitive function as measured by Brief Symptom Inventory		24 months
Neurocognitive function as measured by Beck Depression Inventory-II		24 months
Neurocognitive function as measured by ASSIST (substance abuse)		24 months
Neurocognitive function as measured by Base ATN Adherence Questions		24 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: John W sleasman, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2019
• Primary Completion (Actual): January 26, 2023
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: substance use
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Marijuana Use
• Other Study ID Numbers: Pro00100780

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No