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Cannabis Effects on Antiretroviral Therapy Pharmacokinetics and Neurotoxicity

NCT04800159 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-15

No results posted yet for this study

Summary

This study will address whether cannabis affects antiretroviral therapy (ART) drug concentrations, mood, and thinking. The project will have two phases. Phase 1 is an observational study, in which 120 people will be assessed to evaluate the effects of chronic cannabis use on ART drug concentrations, mood, and thinking. In Phase 2, the study will administer cannabis (or placebo) to 40 people to examine its acute effects on ART drug concentrations.

Conditions

  • HIV
  • Cannabis Use

Interventions

DRUG

THC Cannabis

Vaporization of cannabis

DRUG

CBD Cannabis

Vaporization of cannabis

DRUG

Placebo

Vaporization of placebo

Sponsors & Collaborators

Principal Investigators

  • Scott Letendre, MD · UCSD

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-19
Primary Completion
2025-10-30
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04800159 on ClinicalTrials.gov