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Completed

NCT Number: NCT03927053

Consequences of Marijuana Use 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.

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Key information

Conditions

Youth With HIV Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year–28 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke UMC, Durham, North Carolina, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of bio-marker pathways that are abnormal.

    Time frame: 24 months

    This is measured by molecular mechanism of chronic macrophage activation.

  2. Plasma levels of sCD163

    Time frame: 24 months

    Chi-square test will be used to compare discrete variables

  3. Neurocognitive function as measured by Trial Making Test (TMT)

    Time frame: 24 months

  4. Neurocognitive function as measured by WAIS-III (5 subtest IQ estimate)

    Time frame: 24 months

  5. Neurocognitive function as measured by Hopkins Verbal Learning Test-R

    Time frame: 24 months

  6. Neurocognitive function as measured by the Brief Visuospatial Memory Test-R

    Time frame: 24 months

  7. Neurocognitive function as measured by the WRAT-4 Word Reading subtest

    Time frame: 24 months

  8. Neurocognitive function as measured by Activities of Daily Living Questionnaire

    Time frame: 24 months

  9. Neurocognitive function as measured by Behavior Rating Inventory of Executive Functioning

    Time frame: 24 months

  10. Neurocognitive function as measured by Grooved Pegboard test

    Time frame: 24 months

  11. Neurocognitive function as measured by Timed Gait Test

    Time frame: 24 months

  12. Neurocognitive function as measured by Verbal Fluency Test

    Time frame: 24 Months

  13. Neurocognitive function as measured by Brief Symptom Inventory

    Time frame: 24 months

  14. Neurocognitive function as measured by Beck Depression Inventory-II

    Time frame: 24 months

  15. Neurocognitive function as measured by ASSIST (substance abuse)

    Time frame: 24 months

  16. Neurocognitive function as measured by Base ATN Adherence Questions

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 25, 2019
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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