RECRUITING

Cannabis, HIV and Mental Processing Systems

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study employs novel methods to identify key determinants and consequences of concurrent HIV infection and regular cannabis use. This study will acquire extensive phenotype data from peripheral and brain markers of immune activation, brain structure, and neuropsychological performance (NP) in persons living with HIV (PLWH) receiving combination anti-retroviral therapy (cART) (80 regular cannabis users and 80 non-users) and HIV uninfected (HIV-) controls (80 regular cannabis users and 80 non-users). This study will provide key insights into the effects of regular cannabis and HIV on peripheral and brain markers of immune function and NP in PLWH and HIV- controls. These insights are critical for cure strategies and ongoing HIV treatment initiatives.

Official Title

Cannabis, HIV and Mental Processing Systems

Quick Facts

Study Start:2022-03-23

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05430490

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants must be 18-70 years old. 2. PLWH must have documented HIV infection for approximately 1 year, be on a cART regimen for approximately ≥3 months, and be virally well-controlled (\< 200 copies/mL). 3. HIV- controls must have confirmed HIV- serostatus. 4. Participants must complete at least 9 years of education. 5. Participants must be able to provide informed consent. 6. Female participants must have a negative pregnancy test or written documentation of tubal ligation, hysterectomy, post-menopausal status, etc. and cannot be breastfeeding. 7. Participants should have no contraindications to an MRI scan. 8. Participants should be willing to have cannabis use history confirmed via clinical interview and urine analysis . 9. All inclusion criteria at PI discretion.	1. History of neurological disorder (e.g., stroke, head injury with loss of consciousness for \>5 minutes, developmental learning disability, etc.). 2. Uncontrolled major affective disorder; history of bipolar disorder or schizophrenia. Major depression controlled with no hospitalizations or suicidal ideation in the past year is allowed. 3. Current substance use disorder (SUD) as defined by DSM-5 criteria besides cannabis use disorder (CUD) (though a past SUD \> 1 year before the time of study enrolment will be allowed). 4. currently prescribed anti-coagulants (only exclusionary if participant will engage in optional LP). 5. an allergy to lidocaine or similar anesthetic (only exclusionary if participant will engage in optional LP). 6. a history of a bleeding disorder (only exclusionary if participant will engage in optional LP). 7. claustrophobia or a pacemaker that would prevent magnetic resonance imaging (MRI) scanning. 8. all exclusion criteria at PI discretion.

Inclusion Criteria

Exclusion Criteria

1. Participants must be 18-70 years old.
2. PLWH must have documented HIV infection for approximately 1 year, be on a cART regimen for approximately ≥3 months, and be virally well-controlled (\< 200 copies/mL).
3. HIV- controls must have confirmed HIV- serostatus.
4. Participants must complete at least 9 years of education.
5. Participants must be able to provide informed consent.
6. Female participants must have a negative pregnancy test or written documentation of tubal ligation, hysterectomy, post-menopausal status, etc. and cannot be breastfeeding.
7. Participants should have no contraindications to an MRI scan.
8. Participants should be willing to have cannabis use history confirmed via clinical interview and urine analysis .
9. All inclusion criteria at PI discretion.

1. History of neurological disorder (e.g., stroke, head injury with loss of consciousness for \>5 minutes, developmental learning disability, etc.).
2. Uncontrolled major affective disorder; history of bipolar disorder or schizophrenia. Major depression controlled with no hospitalizations or suicidal ideation in the past year is allowed.
3. Current substance use disorder (SUD) as defined by DSM-5 criteria besides cannabis use disorder (CUD) (though a past SUD \> 1 year before the time of study enrolment will be allowed).
4. currently prescribed anti-coagulants (only exclusionary if participant will engage in optional LP).
5. an allergy to lidocaine or similar anesthetic (only exclusionary if participant will engage in optional LP).
6. a history of a bleeding disorder (only exclusionary if participant will engage in optional LP).
7. claustrophobia or a pacemaker that would prevent magnetic resonance imaging (MRI) scanning.
8. all exclusion criteria at PI discretion.

Contacts and Locations

Study Contact

Elizabeth Westerhaus

CONTACT

314-747-1125

elizabethwesterhaus@wustl.edu

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Temple University Lewis Katz School of Medicine

Philadelphia, Pennsylvania, 19140

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-23

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2022-03-23

Study Completion Date2025-06-30

Terms related to this study

Additional Relevant MeSH Terms

HIV Infections
Cannabis