Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION)

Date Added
January 2nd, 2024
PRO Number
Pro00130123
Researcher
Kelly Barth

List of Studies


Keywords
Drug Studies, Pain, Psychiatry, Substance Use
Summary

This study aims to investigate innovative approaches to managing chronic pain and opioid use. This study consists of two phases, each offering different treatment options. Participation is voluntary.

This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) transcranial magnetic stimulation by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at follow-up.

Phase 1:
In this initial phase, all participants will have a 1-week open-label trial of buprenorphine (worn as a patch on the arm, shoulder or upper-back). This trial aims to assess the safety and effectiveness of buprenorphine in managing chronic pain and opioid use. During this phase, participants will have the opportunity to experience the effects of buprenorphine under close monitoring.

Phase 2:
After completing Phase 1, participants will have the opportunity to choose their next course of treatment. They can decide to continue with buprenorphine, and undergo a 1-week trial of either real buprenorphine or a placebo (an inactive substance). They will be randomly assigned to receive either real or placebo buprenorphine. If participants respond well to buprenorphine treatment, they may continue the medication under the care of their physician.

Alternatively, participants can explore an alternative treatment called repetitive transcranial magnetic stimulation (rTMS) in Phase 2. If they opt for rTMS, they will receive either real rTMS or a sham version interspersed with cognitive-behavioral therapy for pain. Participants will be randomly assigned to receive either real or sham rTMS.

In both phases, participants will receive close monitoring and attend regular study visits to assess safety and progress. Throughout the study, they will be asked to complete questionnaires about pain, functioning and opioid use, undergo physiological monitoring and blood samples will be collected at specific points.

It's important to note that there are potential risks associated with the study medication, such as difficulty sleeping, nausea, and dizziness. Additionally, for the rTMS arm, there is risk of mild headache, pain at the stimulation site, and there may be unknown risks related to the brain stimulation.

Participants' experience in Phase 1 will involve an open-label trial of buprenorphine, and participants' decisions in Phase 2 will determine the treatment path. While the effectiveness of these treatments is uncertain, participants will receive thorough monitoring throughout the study, and have the option to withdraw at any time. Improvement in participant symptoms is possible but not guaranteed.

Institution
MUSC
Recruitment Contact
Rafael Mendoza
510-629-4209
mendozra@musc.edu

Integrated Treatment for Opioid Use Disorder and PTSD

Date Added
November 5th, 2024
PRO Number
Pro00138487
Researcher
Tanya Saraiya

List of Studies

Keywords
Mental Health, Psychiatry, Substance Use
Summary

This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and postttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.

Institution
MUSC
Recruitment Contact
Tanya Saraiya
347-961-8252
pathlab@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 3 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
Morgan Thomas
843-988-4211
thomamor@musc.edu

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

A pragmatic remote approach to improve transitions of care and retention in opioid use disorder treatment.

Date Added
November 4th, 2025
PRO Number
Pro00146867
Researcher
Allison Smith

List of Studies


Keywords
Psychiatry, Substance Use
Summary

This is a small, test study to see if mailing buprenorphine works for patients with opioid use disorder and a recent medical hospitalization. It tries to remove some of the existing barriers to make it easier to stay in treatment and make it easier for individuals to keep taking their medicine after discharge. The purpose of this research study is to determine if mailing buprenorphine is possible, acceptable, and look at the early results of how well it works.

Institution
MUSC
Recruitment Contact
Hannah Schneider
843-580-8243
schneidh@musc.edu

Internal Barriers to Engaging in Medication Treatment for Opioid Use Disorder

Date Added
December 5th, 2025
PRO Number
Pro00147876
Researcher
Sara Witcraft

List of Studies

Keywords
Substance Use
Summary

This project aims to identify and evaluate internal barriers that inhibit engagement with pharmacological treatment for opioid use disorder (OUD). Participants, consisting of adults diagnosed with OUD, will complete a series of surveys that will take approximately 30 minutes. In conducting this study, investigators intend to identify barriers that could be improved by future interventions.

Institution
MUSC
Recruitment Contact
Sara Witcraft
843-792-3577
witcraft@musc.edu

The Effect of Preoperative Cryotherapy on Pain, Opioid Use, and Early Functional Outcomes Following Anterior Cruciate Ligament Reconstruction

Date Added
March 17th, 2026
PRO Number
Pro00149208
Researcher
Thomas Moran

List of Studies

Keywords
Surgery
Summary

This study will evaluate whether using cold therapy before Anterior Cruciate Ligament (ACL) reconstruction surgery improves recovery during the first six weeks after surgery. Patients undergoing ACL reconstruction will either receive standard preoperative care or standard care plus a period of cold therapy prior to surgery. Pain levels, swelling, medication use, and functional recovery will be tracked using surveys and routine clinical follow-up information. participation will not change the surgical procedure or postoperative rehabilitation plan.

Institution
MUSC
Recruitment Contact
Katie Kessler
9195345432
kesslkat@musc.edu

Patient Perspectives on Medications for Opioid Use Disorder (MOUD) in Acute Medical Settings

Date Added
May 12th, 2026
PRO Number
Pro00145318
Researcher
Joshua Moran Jimenez

List of Studies

Keywords
Substance Use
Summary

This study aims to better understand the experiences and perspectives of people with opioid use disorder (OUD) who have recently been hospitalized for a medical condition. Participants will complete a brief, confidential survey about their views on medications for opioid use disorder (MOUD), including barriers to starting treatment, factors that support treatment decisions, and what information they find most helpful. Individuals who meet eligibility criteria will be invited to participate. The information collected will help identify what patients need and prefer when making decisions about MOUD during a hospital stay. Findings from this study will guide the design of a future intervention that reflects patient identified needs and priorities.

Institution
MUSC
Recruitment Contact
Joshua Moran Jimenez
843-792-9182
moranjo@musc.edu



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