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Cannabinoid

CBD for Sleep Disorder in HIV

Phase 2
Recruiting
Research Sponsored by Mariana Cherner, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willingness to stop sedative/hypnotic medication use
Read, speak, and understand English or Spanish as a first language
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline before treatment and after completion of the medication phase at 4 weeks
Awards & highlights

Study Summary

This trial will test whether CBD can help with insomnia in people with HIV. It will last 5 weeks and use daily doses of CBD between 50mg and 600mg.

Who is the study for?
Adults with HIV and sleep problems who can consent, speak English or Spanish, agree to avoid pregnancy, stop using sedatives/hypnotics and substance use. Excluded are those with certain medical conditions like severe psychiatric disorders, cardiovascular risk, uncontrolled hypertension, other sleep disorders besides insomnia, recent substance abuse or dependence.Check my eligibility
What is being tested?
The trial is testing if CBD helps with insomnia in people living with HIV. Participants will randomly receive either a daily dose of CBD (50mg-600mg) or a placebo for 5 weeks. Sleep quality will be tracked via a wrist device and self-reports; cognitive performance tests will assess any changes pre- and post-treatment.See study design
What are the potential side effects?
Potential side effects of CBD may include tiredness, diarrhea, changes in appetite/weight. However specific side effects related to this study's dosage range aren't detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to stop taking sleep or anxiety medication.
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I am fluent in English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline before treatment and after completion of the medication phase at 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline before treatment and after completion of the medication phase at 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in sleep latency assessed by wrist-worn actigraphy
Secondary outcome measures
Change in neurocognitive function based on a combination of tests that measure thinking skills
Change in sleep quality assessed by the Pittsburgh Sleep Quality Index

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CBDExperimental Treatment1 Intervention
Participants will receive oral liquid cannabidiol
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive an inert oral liquid

Find a Location

Who is running the clinical trial?

Mariana Cherner, PhDLead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,467 Previous Clinical Trials
2,619,107 Total Patients Enrolled

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05097651 — Phase 2
Sleep Disorder Research Study Groups: CBD, Placebo
Sleep Disorder Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05097651 — Phase 2
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05097651 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any additional investigations involving Cannabidiol oral solution?

"Currently, 79 clinical trials related to Cannabidiol oral solution are underway. Of these 16 studies have reached the Phase 3 stage of testing. Most of the research sites for this medication are situated in Ribeirao Preto, Sao Paulo; yet a total 289 study locations exist throughout the world."

Answered by AI

Is it possible to volunteer for this experimentation currently?

"This research venture is no longer enrolling participants; it was first announced on January 1st, 2022 and last amended on December 3rd 2021. If you are seeking other clinical trials, 134 studies are presently in search of patients with parasomnias while 79 investigations focus on Cannabidiol oral solution admission."

Answered by AI

What is the purpose of this research endeavor?

"The primary endpoint of this trial, to be evaluated at baseline and after the 4 week medication phase, is Change in sleep latency as measured by wrist-worn actigraphy. Secondary measures include Neurocognitive function (Change in a summary score based on demographically adjusted neuropsychological tests), Sleep Quality (Pittsburgh Sleep Quality Index scores ranging from 0 to 21) and Neurocognitive Function T-scores between 1-100)."

Answered by AI

How many subjects are included in the scope of this clinical investigation?

"At present, this medical trial is not open for recruitment. It was initially posted on the 1st of January 2022 and last edited on December 3rd 2021. There are currently 134 studies seeking individuals with parasomnias and 79 trials searching for participants to partake in Cannabidiol oral solution experiments that are actively recruiting patients."

Answered by AI

Is the ingestion of Cannabidiol oral solution associated with any adverse effects?

"There is data indicating Cannabidiol's safety, but no evidence that it has any efficacy; this earns the drug a rating of 2 on our 1-3 scale."

Answered by AI

Who else is applying?

What site did they apply to?
University of California San Diego School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
~9 spots leftby Oct 2025