A Study Of Synthetic THC And Sleep

NCT07570953 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-009764
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if oral dronabinol prior to sleep can improve CPAP adherence and sleep quality in humans. We also seek to determine if combination therapy of CPAP and pre-sleep dronabinol is associated with improved BP regulation. We will also explore BP regulatory mechanisms and whether these are impacted differently between traditional CPAP therapy and combination CPAP/dronabinol.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• Number of times subjects complete CPAP therapy

  CPAP therapy is defined as using the therapeutic device for ≥ 4 hours per night

  Baseline

• Apnea-hypopnea index (AHI)

  Apnea-hypopnea index (AHI) an index used to describe the number of apneas experienced during sleep. It is calculated by (Number of hours of sleep/Number of Apneas or hypopneas). This value will then be graded on a scale from Normal (\<5) to Severe (\>30).

  Day 15, Day 29, and Day 42

• International Physical Activity Questionnaire

  International Physical Activity Questionnaire is a 0-10 visual analog scale to assess self-reported sleep quality

  Baseline and Day 42

Secondary Outcomes (2)

• 24-hour blood pressure

  Baseline and Day 42

• Blood Pressure

  Baseline, Day 22, and Day 42

Study Arms (2)

Dronabinol

EXPERIMENTAL

Patients assigned to the Dronabinol arm will be taking the Study drug (Dronabinol) one hour prior to bed each night for 6 weeks.

Drug: Dronabinol

Placebo

PLACEBO COMPARATOR

Patients assigned to the placebo arm will be taking the placebo pill (sugar pill) one hour prior to bed each night for 6 weeks.

Drug: Placebo

Interventions

Dronabinol DRUG

10 mg dose of Dronabinol daily for 6 weeks

Dronabinol

Placebo DRUG

10 mg dose of Placebo daily for 6 weeks

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Biological male or female
• AHI between 15 - 50 events/hour

You may not qualify if:

• BMI \> 35 kg/m2
• Diagnosed psychiatric disorders
• Hypotension
• History of seizures
• History of substance abuse or recreational drug use or positive urine drug screen
• History of uncontrolled disease including:
• Cardiovascular
• Pulmonary
• Gastrointestinal
• Pancreatic
• Hepatic
• Renal
• Hematological
• Endocrine (including Type I Diabetes)
• Neurological

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Virend Somers, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chieko Allgauer

CONTACT

507-422-3499; allgauer.chieko@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)