NCT01755091

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2013

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 22, 2017

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

3.3 years

First QC Date

December 18, 2012

Results QC Date

October 24, 2017

Last Update Submit

July 27, 2021

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (3)

  • Change in Apnea/Hypopnea Index (AHI)

    Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment)

    Baseline and Week 6

  • Change in Epworth Sleepiness Scale (ESS)

    Change in ESS derived as: ESS (end of treatment) minus ESS (pre-treatment). The ESS scale has a range of 0 to 24, with 0 representing the least degree of sleepiness and 24 the greatest degree of sleepiness. There are no subscales.

    Baseline and Week 6

  • Change in Sleep Latency: Maintenance of Wakefulness Test (MWT)

    Change in MWT derived as: MWT (end of treatment) minus MWT (pre-treatment). The Maintenance of Wakefulness Test measures a person's ability to stay awake in a quiet, dark and nonstimulating room for a period of time.

    Baseline and Week 6

Secondary Outcomes (3)

  • Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.

    Week 6

  • Adverse Events (AEs)

    Up to 8 weeks

  • Change in Desaturation Time (DT)

    6 weeks

Study Arms (3)

Sugar Pill

PLACEBO COMPARATOR

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

Drug: Placebo (for Dronabinol)

2.5 mg/day

EXPERIMENTAL

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

Drug: Dronabinol

10 mg/day

EXPERIMENTAL

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

Interventions

DronabinolDRUG
10 mg/day2.5 mg/day
Placebo (for Dronabinol)DRUG
Sugar Pill

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult 21 to 64 years of age;
  • ≤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).

You may not qualify if:

  • 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;
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • Carley DW, Prasad B, Reid KJ, Malkani R, Attarian H, Abbott SM, Vern B, Xie H, Yuan C, Zee PC. Pharmacotherapy of Apnea by Cannabimimetic Enhancement, the PACE Clinical Trial: Effects of Dronabinol in Obstructive Sleep Apnea. Sleep. 2018 Jan 1;41(1):zsx184. doi: 10.1093/sleep/zsx184.

    PMID: 29121334DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
David W. Carley, PhD
Organization
University of Illinois at Chicago
dwcarley@uic.edu
312-996-3827

Study Officials

  • David W Carley, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 21, 2012

Study Start

February 1, 2013

Primary Completion

June 1, 2016

Study Completion

December 31, 2016

Last Updated

July 29, 2021

Results First Posted

December 22, 2017

Record last verified: 2021-07

Locations

US(2)