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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Illinois at Chicago
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
David W. Carley, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01755091
First received: December 18, 2012
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Sleep Apnea, Obstructive
Drug: Dronabinol
Drug: Placebo (for Dronabinol)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cannabimimetic Treatment of Obstructive Sleep Apnea: A Proof of Concept Trial

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Change in apnea/hypopnea index (AHI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment)

  • Change in Epworth Sleepiness Scale (ESS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change in ESS derived as: ESS (end of treatment) minus ESS (pre-treatment)

  • Change in sleep latency: Maintenance of Wakefulness Test (MWT) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change in MWT derived as: MWT (end of treatment) minus MWT (pre-treatment)


Secondary Outcome Measures:
  • Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Adverse Events (AEs) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
    AEs will be evaluated and tracked throughout subject participation (up to 8 weeks)

  • Change in Desaturation Time (DT) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change in DT (total minutes with arterial oxygen saturation below 85% during 8-hour polysomnography) derived as: DT (end of treatment) minus DT (pre-treatment)


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
Placebo, once per day (QD) by mouth, 60 minutes before bedtime for 6 weeks after 1-week run-in
Drug: Placebo (for Dronabinol)
Experimental: 2.5 mg/day
Dronabinol, 2.5 mg QD by mouth, 60 minutes before bedtime for 6 weeks after 1-week placebo run-in
Drug: Dronabinol
Experimental: 10 mg/day
Dronabinol, 10 mg QD by mouth, 60 minutes before bedtime for 4 weeks after 1-week placebo run-in and 2-week dose escalation
Drug: Dronabinol

  Eligibility

Ages Eligible for Study:   21 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755091

Contacts
Contact: Julie Law, BS 312-996-5176 julielaw@uic.edu
Contact: David W Carley, PhD 312-996-3827 dwcarley@uic.edu

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Julie Law, BS    312-996-5176    julielaw@uic.edu   
Sub-Investigator: Bharati Prasad, MD         
Sub-Investigator: Hui Xie, PhD         
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Rosemary Ortiz    312-908-1024    r-ortiz@northwestern.edu   
Contact: Natalie Pace    312-908-0029    natalie.pace@northwestern.edu   
Principal Investigator: Phyllis Zee, MD, PhD         
Sub-Investigator: Kathy Reid, PhD         
Sub-Investigator: Hrayr Attarian, MD         
Sub-Investigator: Roneil Malkani, MD         
Sponsors and Collaborators
University of Illinois at Chicago
Northwestern University
Investigators
Principal Investigator: David W Carley, PhD University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: David W. Carley, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01755091     History of Changes
Other Study ID Numbers: UM1HL112856 2011-06400
Study First Received: December 18, 2012
Last Updated: February 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 18, 2014