CBD for Sleep in People With HIV

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will obtain preliminary information about whether, and at what dose, cannabidiol (CBD) may help with insomnia in people living with human immunodeficiency virus (HIV). The study will be a 5-week randomized, double-blind placebo-controlled phase II trial using daily oral CBD doses between 50mg and 600mg. Sleep problems will be measured using a wrist-worn device and by self-report. Performance on tests of thinking skills will be compared before and after CBD/placebo treatment. Positive study results will provide support for the use of CBD as a potential treatment for insomnia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mariana Cherner, PhD
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:

• HIV+ and HIV- adults with complaints of sleep problems

• Ability to provide informed consent;

• Read, speak, and understand English or Spanish as a first language;

• Willingness to stop sedative/hypnotic medication use;

• Willingness to abstain from substance use;

• Willingness to prevent pregnancy.

Exclusion Criteria:

• Inability to provide informed consent;

• Medical conditions other than HIV disease that may confound study results or pose risk when participating in the study;

• Neurologic disorder that could compromise interpretation of study findings, such as seizure disorder, stroke, demyelinating diseases, or head injury with loss of consciousness for greater than 30 minutes or resulting in neurologic complications; and other non-HIV neurological disorders;

• Severe psychiatric disorder that might make the person's participation in the study problematic or unsafe, including psychiatric disorder with psychotic features, severe depression, or suicidality;

• Current sedative/hypnotic use for a non-sleep related indication or abuse within the last 12 months;

• Use of marijuana, CBD, or other natural or synthetic cannabinoids in the last 30 days;

• Any moderate to severe substance use disorder (dependence) in the last 12 months;

• Any mild substance use disorder (abuse) in the last 30 days;

• Pregnancy or lactation, or unwillingness to prevent pregnancy during the trial;

• Compromised liver or kidney function;

• Evidence of cardiovascular risk,

• Uncontrolled hypertension;

• Chronic pulmonary disease;

• Obstructive sleep apnea, narcolepsy, or other non-insomnia sleep diagnosis;

• Overnight-shift work.