ACTIVE_NOT_RECRUITING

Oral Dronabinol-HIV

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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

The purpose of this study is to define the mechanisms of cannabis on the genome of people with HIV who use cannabis. The investigator aims to better understand the effect of Dronabinol on immune and inflammatory functions, and whether these changes are HIV-status dependent. This research may better inform public health policy regarding cannabis use. Depending on the results, additional studies may also build upon this research to develop more effective and specific treatments for cannabis use associated disorders.

Official Title

Investigation of the Effects of Cannabis on the Immune-genome in People With HIV

Quick Facts

Study Start:2023-09-21

Study Completion:2028-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06034314

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Current or past Cannabis use. * HIV-positive on antiretroviral therapy. * Meet criteria of viral suppression (viral load less than approximately 400 copies/ml). * Good physical and mental health as determined by history, the SCID, collateral information, physical and laboratory examinations, ECG, and vital signs. * Women of Childbearing Potential: Must agree to use or have their partner use one acceptable method of birth control throughout the study, at the discretion of the principal investigator.	* Cannabis naïve individuals. * Under the age of 18 years. * Unable to provide written informed consent. * Unable to read or write in English. * Unable to tolerate the effects of smoking approximately half a joint of cannabis (or equivalent), at the discretion of the principal investigator. * Major or clinically unstable medical conditions (e.g., myocardial infarction, hypertension, clinically significant head injury or loss of consciousness). * IQ less than 80. * Diagnosis of psychosis confirmed by SCID. * Other medical, psychiatric, or psychosocial history that is deemed unsuitable for participation in study per PI. * Has donated blood within the last 8 weeks. * Sesame oil allergy. * Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants (e.g., barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants). * Patients with cardiac disorders or concomitant use of other drugs that are associated with similar cardiac effects (e.g., amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, other tricyclic antidepressants). * Patients with a history of seizures, including those receiving anti-epileptic medication or with other factors that can lower the seizure threshold.

Inclusion Criteria

Exclusion Criteria

* Current or past Cannabis use.
* HIV-positive on antiretroviral therapy.
* Meet criteria of viral suppression (viral load less than approximately 400 copies/ml).
* Good physical and mental health as determined by history, the SCID, collateral information, physical and laboratory examinations, ECG, and vital signs.
* Women of Childbearing Potential: Must agree to use or have their partner use one acceptable method of birth control throughout the study, at the discretion of the principal investigator.

* Cannabis naïve individuals.
* Under the age of 18 years.
* Unable to provide written informed consent.
* Unable to read or write in English.
* Unable to tolerate the effects of smoking approximately half a joint of cannabis (or equivalent), at the discretion of the principal investigator.
* Major or clinically unstable medical conditions (e.g., myocardial infarction, hypertension, clinically significant head injury or loss of consciousness).
* IQ less than 80.
* Diagnosis of psychosis confirmed by SCID.
* Other medical, psychiatric, or psychosocial history that is deemed unsuitable for participation in study per PI.
* Has donated blood within the last 8 weeks.
* Sesame oil allergy.
* Concomitant use of other drugs that cause dizziness, confusion, sedation, or somnolence such as CNS depressants (e.g., barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, scopolamine, antihistamines, tricyclic antidepressants, other anticholinergic agents, muscle relaxants).
* Patients with cardiac disorders or concomitant use of other drugs that are associated with similar cardiac effects (e.g., amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, other tricyclic antidepressants).
* Patients with a history of seizures, including those receiving anti-epileptic medication or with other factors that can lower the seizure threshold.

Contacts and Locations

Principal Investigator

Ke Xu, MD, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Connecticut Mental Health Center

New Haven, Connecticut, 06511

United States

Collaborators and Investigators

Sponsor: Yale University

Ke Xu, MD, PhD, PRINCIPAL_INVESTIGATOR, Yale University

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 Date2023-09-21

Study Completion Date2028-10-01

Study Record Updates