Cannabis, HIV and Mental Processing Systems

HIV Infections Clinical Trial

— CHAMPS  

Official title:

Cannabis, HIV and Mental Processing Systems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430490
• Other study ID #: 202107149
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Washington University School of Medicine
• Contact: Elizabeth Westerhaus
• Phone: 314-747-1125
• Email: elizabethwesterhaus[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion 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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Cannabis
• HIV Infections
• Marijuana Abuse

Intervention

Procedure:
• MRI
Multimodal neuroimaging on 3T Prisma Fit MRI

Other:
• NeuroPsychological Testing
A series of written, verbal, and motor tasks requiring the participant to follow instructions, remember words and numbers, draw objects, and complete timed actions.

Procedure:
• Blood Draw
Laboratory reports (CMP, CBC, Lipids)

Other:
• Questionnaires
Life history, current behaviors, and substance use surveys

Procedure:
• Lumbar Puncture
Optional procedure which involves obtaining cerebral spinal fluid through a needle in the lower back

Locations

Country	Name	City	State
United States	Temple University Lewis Katz School of Medicine	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of cannabis use on peripheral and brain immune activation and inflammation in virally controlled PLWH on cART.	Validated plasma and cerebrospinal fluid (CSF) markers of immune health and inflammation (e.g., CD14, CD16, Neopterin, etc.), as well as novel neuroimaging methods of neuro-inflammation (e.g., DTI & DBSI, 3T MRI) will be used to evaluate brain inflammation.	Years 1-5
Secondary	Effect of cannabis use on cognitive performance and brain structure in both PLWH/CB+ and CON/CB+.	Neuropsychological assessment results will be normed and converted into Z scores for comparison with brain volumes calculated from the 3T.	Years 1-5