CBD for Sleep in People With HIV

NCT05097651 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 201536R21DA053160
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  At baseline before treatment and after completion of the medication phase at 4 weeks

Study Arms (2)

CBD

EXPERIMENTAL

Participants will receive oral liquid cannabidiol

Drug: Cannabidiol oral solution

Placebo

PLACEBO COMPARATOR

Participants will receive an inert oral liquid

Drug: Inert sesame seed oil

Interventions

Cannabidiol oral solution DRUG

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.

CBD

Inert sesame seed oil DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Mariana Cherner, PhD: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of California San Diego School of Medicine

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Parasomnias

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Mariana Cherner, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor IR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 28, 2021
• Study Start: April 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)