CBD for Sleep in People With HIV
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|ClinicalTrials.gov Identifier: NCT05097651|
Recruitment Status : Not yet recruiting
First Posted : October 28, 2021
Last Update Posted : December 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disturbance||Drug: Cannabidiol oral solution Drug: Inert sesame seed oil||Phase 2|
Sleep problems are highly prevalent in people with HIV, and traditional treatment with sedative/hypnotic medications can compound neurocognitive dysfunction. A treatment option without cognitive side effects would be highly desirable for use with this vulnerable population. Cannabidiol (CBD) is a phytocannabinoid component of the marijuana plant that is considered devoid of euphoriant or other psychoactive properties. A small literature demonstrates a broad range of CBD doses at which sleepiness is reported to occur, and also not occur, which indicates the need for controlled studies to ascertain the lowest efficacious dose, as well as the sustainability of effects over a period of repeated use. The proposed clinical trial will seek to 1) Ascertain the dose range of CBD that is useful in managing symptoms of insomnia and improving sleep quality, and 2) determine whether CBD use has any next-morning cognitive sequelae measured objectively with a neuropsychological test battery.
In the proposed five-week clinical trial, investigators will use a liquid solution that is 100 mg/mL of CBD formed from semi synthetic CBD powder suspended in sesame oil. Eligible participants will be randomized into either a CBD or Placebo group. At the baseline visit, participants will be fitted with a wrist-worn actigraph to measure activity and light exposure, which they were wear for 5 weeks to estimate their rest/ activity cycle.
After a 7-day baseline period, participants will be instructed to take 50mg of CBD/placebo to begin the titration phase. They will slowly increase their daily dose by 50mg/day until they achieve relief from symptoms of insomnia. This includes the option to remain on the minimum study dose of 50 mg daily to a maximum medication limit of 600 mg daily. Participants will return weekly to monitor vital signs, download actigraphy data, and receive the next allotment of study medication. Clinical labs, self-reported sleep, fatigue, and mood, as well neuropsychological test performance will be be measured at baseline and at the end of the medication maintenance phase. Participants will also be instructed to use a daily diary to record sleep and other health related items, as well as adherence to the study regimen for the duration of the study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Trial of Cannabidiol (CBD) for Sleep Problems in People With HIV|
|Estimated Study Start Date :||January 2022|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||December 2023|
Participants will receive oral liquid cannabidiol
Drug: Cannabidiol oral solution
Cannabidiol 100mg/mL in a sesame seed oil, strawberry flavored solution, taken orally at bedtime in self-titrated dose between 50mg and 600mg. Once a dose that results in relief of symptoms is reached, it will remain as the maintenance dose, not to exceed 600mg.
Placebo Comparator: Placebo
Participants will receive an inert oral liquid
Drug: Inert sesame seed oil
Placebo will be identical strawberry flavored sesame seed oil-based solution without CBD.
- Change in sleep latency assessed by wrist-worn actigraphy [ Time Frame: At baseline before treatment and after completion of the medication phase at 4 weeks ]We will determine whether the study drug affects how quickly people fall asleep using a motion/activity sensor called an actigraph that is worn on the wrist.
- Change in sleep quality assessed by the Pittsburgh Sleep Quality Index [ Time Frame: At baseline before treatment and after completion of the medication phase at 4 weeks ]We will determine whether the study drug affects self-reported sleep quality using a paper-and-pencil measure called the Pittsburgh Sleep Quality Index. Scores can range from 0 to 21, with higher score indicating more sleep problems.
- Change in neurocognitive function based on a combination of tests that measure thinking skills [ Time Frame: At baseline before treatment and after completion of the medication phase at 4 weeks ]Change in a summary score based on a combination of demographically adjusted neuropsychological tests with known sensitivity to effects of HIV and the Fluid Composite T-score on the Cognition module of the NIH Toolbox for the Assessment of Neurological and Behavioral Function. T-scores can range between 1-100, with higher scores reflecting better performance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05097651
|Contact: Robert Bryanfirstname.lastname@example.org|
|United States, California|
|University of California San Diego School of Medicine|
|San Diego, California, United States, 92103|
|Contact: Robert Bryan 619-543-5000 email@example.com|
|Principal Investigator: Mariana Cherner, PhD|
|Principal Investigator:||Mariana Cherner, PhD||University of California, San Diego|