Oral Dronabinol-HIV

Last updated: November 11, 2024
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

1

Condition

Hiv

Treatment

Dronabinol Capsules

Clinical Study ID

NCT06034314
2000035807
1R01DA052846-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

PWH Inclusion Criteria:

  • Current or past Cannabis use.

  • HIV-positive on antiretroviral therapy.

  • Meet criteria of viral suppression (viral load less than approximately 400copies/ml).

  • Good physical and mental health as determined by history, the SCID, collateralinformation, physical and laboratory examinations, ECG, and vital signs.

  • Women of Childbearing Potential: Must agree to use or have their partner use oneacceptable method of birth control throughout the study, at the discretion of theprincipal investigator.

PWoH Inclusion Criteria:

  • Current or past Cannabis use.

  • Good physical and mental health as determined by history, the SCID, collateralinformation, physical and laboratory examinations, ECG, and vital signs.

  • Women of Childbearing Potential: Must agree to use or have their partner use oneacceptable method of birth control throughout the study, at the discretion of theprincipal investigator.

Exclusion

Exclusion Criteria:

  • 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 (orequivalent), 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 forparticipation 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, orsomnolence 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 areassociated with similar cardiac effects (e.g., amphetamines, other sympathomimeticagents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergicagents, amitriptyline, desipramine, other tricyclic antidepressants).

  • Patients with a history of seizures, including those receiving anti-epilepticmedication or with other factors that can lower the seizure threshold.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Dronabinol Capsules
Phase: 1
Study Start date:
September 21, 2023
Estimated Completion Date:
October 01, 2027

Connect with a study center

  • Connecticut Mental Health Center

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

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