Sleep DisturbancePhase 2NCT05097651
CBD for Sleep in People With HIV
A Phase 2 study testing Cannabidiol oral solution and Inert sesame seed oil in people with Sleep Disturbance, run by Mariana Cherner, PhD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Cannabidiol oral solution and Inert sesame seed oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego School of Medicine
San Diego, California, 92103
About this study
Official title: Pilot Trial of Cannabidiol (CBD) for Sleep Problems in People With HIV
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.
Read the detailed description
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.
- Conditions
- Sleep Disturbance
- Being tested
- Cannabidiol oral solution, Inert sesame seed oil
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol oral solutionDrug
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.
Inert sesame seed oilDrug
Placebo will be identical strawberry flavored sesame seed oil-based solution without CBD.
| Study group | Role | What they receive |
|---|---|---|
| CBD | Experimental | Participants will receive oral liquid cannabidiol Receives: Drug: Cannabidiol oral solution |
| Placebo | Placebo comparator | Participants will receive an inert oral liquid Receives: Drug: Inert sesame seed oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline before treatment and after completion of the medication phase at 4 weeks
Secondary outcomes (2)
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.
Measured: 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
Measured: At baseline before treatment and after completion of the medication phase at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Apr 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Why it stopped: Difficulties enrolling eligible participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mariana Cherner, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Mariana Cherner, PhD, University of California, San Diego
- Investigators
- Mariana Cherner, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097651
- Sponsor's protocol ID
- 201536
- Other IDs
- R21DA053160
- Status last verified
- May 2024
- First submitted
- 5 Oct 2021
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Cannabidiol (CBD) for Sleep Problems in People With HIV
- ClinicalTrials.gov ID
- NCT05097651
- Acronym / sponsor ID
- 201536
- Conditions
- Sleep Disturbance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties enrolling eligible participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mariana Cherner, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD | Experimental | Drug: Cannabidiol oral solutionParticipants will receive oral liquid cannabidiol |
| Placebo | Placebo comparator | Drug: Inert sesame seed oilParticipants will receive an inert oral liquid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol oral solutionCannabidiol 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. | Drug | CBD |
| Inert sesame seed oilPlacebo will be identical strawberry flavored sesame seed oil-based solution without CBD. | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Cherner, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol oral solution and Inert sesame seed oil in people with Sleep Disturbance, run by Mariana Cherner, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.