A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Suvorexant for the Treatment of Insomnia in Participants with Opioid Use Disorder (MK-4305-098)

Date Added
July 18th, 2025
PRO Number
Pro00146129
Researcher
Allison Wilkerson

List of Studies


Keywords
Drug Studies, Sleep Disorders
Summary

This research is being done to see if the drug suvorexant is effective as treatment for insomnia in people who have opioid use disorder and who are utilizing stable medications for opioid use disorder (MOUD). It is a 13-week study, and the study drug will be compared to a placebo.

Institution
MUSC
Recruitment Contact
Kyle Williams
843-876-6399
kyw210@musc.edu

Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons

Date Added
December 3rd, 2024
PRO Number
Pro00141060
Researcher
Sara Witcraft

List of Studies

Keywords
Anxiety, Mental Health, Pregnancy, Psychiatry, Sleep Disorders, Substance Use, Women's Health
Summary

This study involves testing how useful a technology-enhanced, skill building intervention is for pregnant people prescribed buprenorphine for the treatment of opioid use disorder, compared to medication monitoring. Participants are randomized to one of the conditions. Participants randomized to receive the skill building intervention will attend three 60-90-minute therapy appointments during pregnancy with an additional 30-minute therapy session towards the end of pregnancy, and 6 additional monthly postpartum (after childbirth) sessions (0-6 months postpartum). As part of the program, participants will receive access to a mobile application, which will be accessible for the duration of the study. Participants randomized to medication monitoring will be asked to log each time the medication is taken for a two month period. All participants will also be asked to complete questionnaires at enrollment, at the end of pregnancy, 3-month postpartum, and 6-months postpartum, be contacted randomly throughout the study to perform a medication count, and complete a urine drug screen at 6-months postpartum. The total duration of the study is between 9-13 months depending on when enrollment occurs (early second trimester-mid third trimester). Compensation up to $500 is provided.

Institution
MUSC
Recruitment Contact
Maham Dilawar
843-214-4496
dilawarm@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Post-Operative Steroids after Sleep Surgery

Date Added
December 3rd, 2024
PRO Number
Pro00138969
Researcher
Mohamed Abdelwahab

List of Studies

Keywords
Pain, Sleep Disorders, Surgery
Summary

The purpose of this study is to study the effectiveness of steroids after sleep surgery in improving pain, reducing difficulties in swallowing, and reducing the amount of narcotic pain medication after surgery. This study also want to see what dosage of steroids, whether intravenous or oral, are more effective at reducing these symptoms and providing a more effective surgical procedure for your sleep apnea. Anyone planning to undergo sleep surgery for your obstructive sleep apnea at the recommendation of the Sleep Surgery Division here at MUSC is invited to participate in this study. The study will be using both intravenous and oral dexamethasone, a very common and widely used steroid. This steroid has been FDA approved for many medical indications.

Institution
MUSC
Recruitment Contact
Nicolas Poupore
843-792-8299
poupore@musc.edu

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated with Shift Work Disorder

Date Added
November 1st, 2024
PRO Number
Pro00138871
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of Solriamfetol (versus placebo) for the treatment of excessive sleepiness associated with shift work disorder (SWD). Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 18-65 years old with a diagnosis of SWD. The study will last approximately 17 weeks, with 6 in-person visits and 8 remote visits for each participant.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of FT218 in the Treatment of Idiopathic Hypersomnia (IH)

Date Added
October 9th, 2024
PRO Number
Pro00138642
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

This is a study to learn more about the use of a study medicine for the treatment of Idiopathic Hypersomnia (IH). The total duration of the study is approximately 3 1/2 months. Men and women between the ages of 18-75, with a primary diagnosis of IH, may be eligible.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu

EMPWR Pilot Trial: Treatment Retention in Medication for Opioid Use Disorder Among Pregnant and Postpartum Women

Date Added
August 6th, 2024
PRO Number
Pro00137982
Researcher
Sara Witcraft

List of Studies

Keywords
Anxiety, Mental Health, Pregnancy, Psychiatry, Sleep Disorders, Substance Use, Women's Health
Summary

This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief skill building protocol and a mobile application. Participation involves three 60-90-minute skill building appointments during pregnancy, and four 30-minute check-in visits at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll. Compensation is provided.

Institution
MUSC
Recruitment Contact
Maham Dilawar
843-214-4496
dilawarm@musc.edu



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