A Phase 2 interventional study of Cannabidiol oral solution and Inert sesame seed oil in Sleep Disturbance, sponsored by Mariana Cherner, PhD. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Mariana Cherner, PhD · Phase 2, Interventional, and Treatment
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.
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 100mg/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.
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Exclusion Criteria:
Participants will receive oral liquid cannabidiol
Drug: Cannabidiol oral solution
Participants will receive an inert oral liquid
Drug: Inert sesame seed oil
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 will be identical strawberry flavored sesame seed oil-based solution without CBD.
Change in sleep latency assessed by wrist-worn actigraphy
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.
Time frame: At baseline before treatment and after completion of the medication phase at 4 weeks
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index
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.
Time frame: At baseline before treatment and after completion of the medication phase at 4 weeks
Change in neurocognitive function based on a combination of tests that measure thinking skills
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
Time frame: At baseline before treatment and after completion of the medication phase at 4 weeks
Plan to share: Yes — Data and biospecimens collected in the course of this study will be stored in the joint HIV Neurobehavioral Research Center (HNRP) - Center for Medicinal Cannabis Research (CMCR) Data and Biospecimen Repositories for potential future use. De-identified data and biospecimens may be made available to investigators conducting institutional review board (IRB) approved research. Interested investigators will submit a request for data and/or biospecimens. HNRP-CMCR leadership will be responsible for determining who will have access to the data and biospecimens and will ensure that a Data Use Agreement is signed by the requesting investigator. The data and biospecimens will be stored indefinitely, however, if a research participant decides they no longer want their biospecimens to be used, all efforts will be made to stop any additional studies.
Time frame: The data and biospecimens will become available following publication. Data and biospecimens will be stored indefinitely, however, if a research participant decides they no longer want their biospecimens to be used, all efforts will be made to stop any additional studies.
Access criteria: Investigators whose proposed use of the data and/or biospecimens has been approved by the HNRP-CMCR leadership. HNRP-CMCR leadership will ensure that a Data Use Agreement is signed by the requesting investigator.
Data sharing details ↗ · www.cmcr.ucsd.edu
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This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cannabidiol