Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea (PACE)

University of Illinois

Status and phase: Completed; Phase 2

Conditions: Sleep Apnea, Obstructive

Treatments: Drug: Placebo (for Dronabinol); Drug: Dronabinol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01755091

2012-0095

UM1HL112856 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a proof of concept study to determine the safety and efficacy of dronabinol for the treatment of obstructive sleep apnea syndrome (OSA).

Enrollment: 75 patients

Sex: All

Ages: 21 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult 21 to 64 years of age;
• 15≤AHI ≤ 50 on screening polysomnogram (PSG)
• ESS score ≥ 7
• Able to understand and complete informed consent and all study assessments and forms, presented in an English-speaking format;
• Women of child-bearing potential (WCBP) must have a negative urine pregnancy test. In addition sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable or implantable hormonal contraceptive; tubal ligation; intra-uterine devices; barrier contraceptive with spermicide; or vasectomized partner).

Exclusion criteria

• Arterial oxygen saturation < 75% for > 5% of sleep period time on screening PSG;
• Occupation or life situation that may impart risk by study participation (e.g. commercial driver, pilot, police officer, fireman);
• Motor vehicle accident or "near-miss" related to sleepiness (self-report) within 2 years of the first dose of study drug (Day 8);
• Body mass index > 45 kg/m2
• Severe obstructive sleep apnea syndrome (OSAS) that, based on the clinical judgment of the Investigator, precludes delaying positive airway pressure treatment;
• History of shift work or rotating shifts within the month prior to the first dose of study drug (Day 8);
• Prior upper airway surgery for snoring or OSAS as an adult (≥ 18 years of age);
• Prior non-invasive treatment for OSAS within 6 months prior to the first dose of study drug (Day 8);
• Major surgery within 6 months prior to the first dose of study drug (Day 8);
• Bariatric surgery within 2 years prior to the first dose of study drug (Day 8). If post-bariatric surgery, weight must be stable ±5% (self-report) for at least 6 months prior to first dose of study drug (Day 8).
• Any form of medically managed weight loss program within 6 months prior to the first dose of study drug (Day 8);
• Significant defect in nasal patency due to anatomical abnormalities or uncontrolled or recurrent episodes of rhinitis;
• Any clinically significant unstable or progressive medical condition;
• Any primary sleep disorder other than OSAS as determined by history, physical examination, or Visit 2 PSG (after 7-day screening run-in period);
• Clinically significant or uncontrolled: chronic obstructive pulmonary disease (COPD), cardiovascular disease, gastrointestinal, respiratory, pancreatic, hepatic, renal, hematologic, endocrine [including insulin-dependent diabetes mellitus (IDDM)], neurological, urogenital, connective tissue, dermatological, thyroid, or other medical disorder;
• Any clinically significant psychiatric disorder;
• History of seizure disorder;
• Treatment with any prescription antidepressant medication within 1 month prior to the first dose of study drug (Day 8);
• Treatment with sedatives, hypnotics or other psychoactive drugs within 30 days prior to the first dose of study drug (Day 8);
• Any complete blood count (CBC) or liver function test (LFT) laboratory value outside the normal range which, in the clinical judgment of the Investigator renders a subject inappropriate for randomization to treatment;
• Pregnancy [as demonstrated by positive urine human chorionic gonadotropin (hCG) test] or lactation;
• Allergic to cannabinoids or sesame oil;
• History of substance abuse (including alcohol abuse or dependence) or laboratory evidence of drug abuse on the Visit 1 drug-screening panel;
• Use of dietary supplements which in the judgment of the Investigator may impact sleep or breathing behaviors;
• Average daily caffeine consumption > 500 mg/day (~5 cups of coffee);
• Average weekly alcohol consumption > 10 units;
• Unwillingness to abstain from caffeine and alcohol on all days when overnight or daytime testing will be performed;
• Participation in any other investigational protocol within the 30 days prior to the first dose of study drug (Day 8);
• Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he or she were to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

Sugar Pill

Placebo Comparator group

Description:

Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in

Treatment:

Drug: Placebo (for Dronabinol)

2.5 mg/day

Experimental group

Description:

Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in

Treatment:

Drug: Dronabinol

10 mg/day

Experimental group

Description:

Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation

Treatment:

Drug: Dronabinol