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CBD for Sleep in People With HIV

NCT05097651 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-05-10

No results posted yet for this study

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.

Conditions

  • Sleep Disturbance

Interventions

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.

DRUG

Inert sesame seed oil

Placebo will be identical strawberry flavored sesame seed oil-based solution without CBD.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Mariana Cherner, PhD

    lead OTHER

Principal Investigators

  • Mariana Cherner, PhD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-08-31
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05097651 on ClinicalTrials.gov