Trial Outcomes & Findings for The Efficacy of Suvorexant in Treatment of Patients With Substance Use Disorder and Insomnia: A Pilot Open Trial (NCT NCT03412591)

NCT ID: NCT03412591

Last Updated: 2024-02-13

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

28 participants

Primary outcome timeframe

7 days

Results posted on

2024-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.	Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
Overall Study STARTED	6	22
Overall Study COMPLETED	5	13
Overall Study NOT COMPLETED	1	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.	Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
Overall Study Withdrawal by Subject	1	8
Overall Study Adverse Event	0	1

Baseline Characteristics

The Efficacy of Suvorexant in Treatment of Patients With Substance Use Disorder and Insomnia: A Pilot Open Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder n=6 Participants It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.	Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder n=22 Participants It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.	Total n=28 Participants Total of all reporting groups
Age, Continuous	35.00 years STANDARD_DEVIATION 10.95 • n=5 Participants	40.91 years STANDARD_DEVIATION 12.49 • n=7 Participants	39.64 years STANDARD_DEVIATION 12.24 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	22 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	22 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Outcome measures
Measure	Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder n=4 Participants It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.	Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder n=14 Participants It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
Change in Total Sleep Time as Measured by Actigraphy and Sleep Logs Relative to Baseline Over the Course of 7 Days of Treatment With Suvorexant in Substance Use Disorder Patients.	-43.25 minutes Standard Deviation 61.96	12.68 minutes Standard Deviation 41.42

SECONDARY outcome

Timeframe: 7 days

Saliva samples were collected at five time points each day for four days, two days at baseline (Days 1 and 2) and two days at study end (Days 7 and 8). Baseline cortisol calculated as average of Days 1 and 2; endpoint cortisol calculated as average of Days 7 and 8.

Outcome measures

Outcome measures
Measure	Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder n=5 Participants It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.	Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder n=13 Participants It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
Relative to a Baseline, Change in Total Daily Salivary Cortisol Over the Course of 7 Days of Treatment With Suvorexant in Substance Use Disorder Patients.	1.85 ng/ml Standard Deviation 9.82	-0.58 ng/ml Standard Deviation 6.55

SECONDARY outcome

Timeframe: 7 days

The data were collected via Motorola Droid smart phones that are programmed to elicit the participants' response four times per day, during each of the 9 full study days. Change in Modified Desire for Drug Scale measured on a 100-point Likert scale (0 = no craving, 100 = maximal craving). A negative change score indicates a decrease in craving across study time.

Outcome measures

Outcome measures
Measure	Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder n=5 Participants It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.	Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder n=11 Participants It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
Relative to a Baseline, Change in Daily Reports of Craving Using Ecological Momentary Assessment (EMA Data) Over the Course of 7 Days of Treatment With Suvorexant in Substance Use Disorder Patients.	-14.47 score on a scale Standard Deviation 18.43	-8.70 score on a scale Standard Deviation 13.18

SECONDARY outcome

Timeframe: 7 days

Endorsement of scale items associated with abuse liability 30 minutes after drug administration or the following morning. Change in Modified Abuse Liability Item Scores (0 = no change in abuse liability, 4 = maximal change in abuse liability).

Outcome measures

Outcome measures
Measure	Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder n=5 Participants It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.	Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder n=14 Participants It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
Change in Scale Items on a Modified Abuse Liability Assessment Battery Relative to Baseline. Modified Liability Score (0-4 scale)	0.29 score on a scale Standard Deviation 0.36	0.10 score on a scale Standard Deviation 0.17
Change in Scale Items on a Modified Abuse Liability Assessment Battery Relative to Baseline. Abuse Liability Question (use drug to get high)	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0
Change in Scale Items on a Modified Abuse Liability Assessment Battery Relative to Baseline. Abuse Liability Question (buy drug illegally)	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0

Adverse Events

Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder n=6 participants at risk It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.	Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder n=22 participants at risk It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
Nervous system disorders Cataplexy-like event	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.

Other adverse events

Additional Information

Dr. Scott Bunce

Penn State College of Medicine

Phone: 2155108295

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Open Label Trial of Suvorexant in Individuals With Opioid Use Disorder n=6 participants at risk It is an open label trial to study the efficacy of suvorexant in a group of patients with opioid use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.	Open Label Trial of Suvorexant in Individuals With Alcohol Use Disorder n=22 participants at risk It is an open label trial to study the efficacy of suvorexant in a group of patients with alcohol use disorder. Suvorexant 20 mg: Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
General disorders feeling cold	16.7% 1/6 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	0.00% 0/22 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
General disorders tachycardia with other general disorder symptoms	16.7% 1/6 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	0.00% 0/22 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
General disorders vivid dreams	33.3% 2/6 • Number of events 2 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	0.00% 0/22 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
General disorders nightmares	16.7% 1/6 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	0.00% 0/22 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
General disorders inability to move	16.7% 1/6 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	0.00% 0/22 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
Cardiac disorders tachycardia alone	16.7% 1/6 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	0.00% 0/22 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
Musculoskeletal and connective tissue disorders tingling in legs	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
General disorders sleepiness	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
General disorders headache	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
Musculoskeletal and connective tissue disorders increased leg cramps	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
Musculoskeletal and connective tissue disorders increased elbow pain	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
Infections and infestations runny nose	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
Infections and infestations post-nasal drip	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
Infections and infestations headache as part of cold	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
Infections and infestations feeling tired	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
Infections and infestations ear pain	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.
Musculoskeletal and connective tissue disorders lower back pain	0.00% 0/6 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.	4.5% 1/22 • Number of events 1 • 10 days Subjects were routinely questioned about adverse events from nursing staff during each nightly administration.