Status:
COMPLETED
The Efficacy of Suvorexant in Treatment of Patients With Substance Use Disorder and Insomnia: A Pilot Open Trial
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Sleep Disturbance
Craving
Eligibility:
All Genders
21-64 years
Phase:
PHASE2
PHASE3
Brief Summary
Insomnia is an extremely common and poorly treated problem in patients with substance use disorders (SUD)s undergoing rehabilitation treatment in a residential facility. The persistence of insomnia in...
Detailed Description
Insomnia is an extremely common and poorly treated problem in patients with substance use disorders (SUD)s patients undergoing rehabilitation treatment in residential facility. The persistence of inso...
Eligibility Criteria
Inclusion
- Sex: male or female
- Age: 21-64 (inclusive) years old
- Caron Foundation residential alcohol or opioid dependent patients that have a history of daily or near daily substance use for the month prior to admittance.
- Group 1: at least five days post medically assisted withdrawal for alcohol dependence, and complain of problems falling asleep, remaining asleep after sleep onset, or poor sleep quality on current sleep medication (antidepressant/melatonin).
- Group 2: at least five days post medically assisted withdrawal for opioid dependence and complain of problems falling asleep, remaining asleep after sleep onset, or poor sleep quality on current sleep medication (antidepressant/melatonin).
- Fluent in written and spoken English.
Exclusion
- Patients who are concurrently receiving a psychoactive drug for the treatment of an Axis I disorder excluding sedating antidepressants that have been prescribed for the treatment of sleep disturbance.
- Patients with current major depressive disorder, schizophrenia, bipolar disorder, post traumatic stress disorder, or a history of traumatic brain injury.
- Patients with a history of narcolepsy or REM related phenomenon.
- Patients with chronic respiratory problems including asthma, COPD, or other respiratory issues that can lead to sleep disturbances at night.
- Patients with current suicidal ideation, or a history of previous suicide attempts.
- Patients with severe liver impairment.
- Women who are pregnant or breastfeeding.
- Patients who are severely obese.
- Decisional impairment
- Prisoners or under legal mandate.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03412591
Start Date
July 1 2019
End Date
January 7 2023
Last Update
February 13 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Richard J Caron Foundation
Wernersville, Pennsylvania, United States, 19567