Impact of lofexidine on stress, craving and opioid use

Date Added
September 4th, 2018
PRO Number
Pro00081381
Researcher
Kathleen Brady

List of Studies


Keywords
Drug Studies, Psychiatry
Summary

The purpose of this study is to determine if the medication lofexidine, taken together with buprenorphine or methadone, is more effective at reducing opioid craving, use and stress response than buprenorphine or methadone alone, and to see if this effect is different for men and women. Participants are randomly assigned to add either lofexidine or placebo to their buprenorphine or methadone treatment for five weeks. They return at the end of five weeks to participate in an opioid imagery task and stress task. Throughout the study, participants complete "CREMA" sessions (Cue Reactivity Ecologic Momentary Assessment) using an iPhone app three times a day. These sessions include looking at stressful and neutral pictures and rating stress and craving.

Institution
MUSC
Recruitment Contact
Amanda Wagner
843-792-0484
wagne@musc.edu

Randomized, Double-Blind, Placebo-Controlled clinical trial of post-operative steroids and pain control after tonsillectomy

Date Added
October 2nd, 2018
PRO Number
Pro00081346
Researcher
Clarice Clemmens

List of Studies


Keywords
Pain, Surgery
Summary

Pain control after tonsillectomy is imperative but often difficult. Current post-operative pain medication regimens include opioid analgesics and are often still inadequate. Though not standard of care, it is our practice to prescribe a single dose of oral steroid medication on the third day after surgery, when pain and swelling are at their peak, in order to assist with pain control and reduce opioid consumption. Though this practice has a rational theoretical basis, there is no prospective data supporting or discounting it. We aim to compare pain control, opioid consumption, and complication rates in children receiving post-operative steroids versus those who do not.

Institution
MUSC
Recruitment Contact
Joshua Horton
843-792-2300
hortojos@usc.edu

Medication treatment for Opioid use disorder in expectant Mothers (MOMS): a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations

Date Added
August 27th, 2019
PRO Number
Pro00091146
Researcher
Constance Guille

List of Studies


Keywords
Obstetrics and Gynecology, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

The primary purpose of this study is to compare extended-release buprenorphine (CAM2038) to buprenorphine placed under the tongue (sublingual) in pregnant women with opioid use disorder to see if CAM2038 is as effective as sublingual buprenorphine. We are looking to recruit pregnant women who are between 18-41 years old; are between 6-30 weeks pregnant and are not planning to terminate the pregnancy; have opioid use disorder, and are enrolled or are planning to enroll in outpatient buprenorphine treatment at The Medical University of South Carolina. Participation in the study would last between 13 and 21 months total with up to between about 63-102 total visits, including weekly medication check visits and research visits.

Institution
MUSC
Recruitment Contact
Savannah Lee
8437920376
leesav@musc.edu

tDCS Combined with a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans

Date Added
October 1st, 2019
PRO Number
Pro00091450
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Brain, Joint, Mental Health, Military, Pain, Psychiatry, Surgery
Summary

The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI).

This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles.

This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). You may benefit in the form of decreased pain and opioid requirements following your knee or hip replacement surgery. However, benefit is only likely if you are randomized to one of the 3 (out of 4) groups.

This study hopes to determine the effects of these interventions and their combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.

Institution
MUSC
Recruitment Contact
Georgia Mappin
(843) 789-7104
georgia.mappin@va.gov

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of Ketamine for the Treatment of Concurrent Opioid Use Disorder and Major Depressive Disorder

Date Added
November 5th, 2019
PRO Number
Pro00091292
Researcher
Jennifer Jones

List of Studies


Keywords
Depression, Mental Health, Psychiatry, Substance Use
Summary

The purpose of the study is to examine whether an investigational medication called ketamine is able to improve treatment outcomes for concurrent opioid addiction and depression when used in conjunction with standard of care medications (such as buprenorphine, methadone or naltrexone). Study medications will be delivered twice per week for four weeks. If you are eligible and you decide to enroll in the study, your participation will last approximately 8-12 weeks, or 2-3 months.

Institution
MUSC
Recruitment Contact
Jennifer Jones
(843) 792-5594
jonjen@musc.edu

Ketamine-assisted psychotherapy for the treatment of persistent depression in abstinent opioid users

Date Added
December 7th, 2021
PRO Number
Pro00115696
Researcher
Eric Dobson

List of Studies

Keywords
Depression, Mental Health, Psychiatry, Substance Use
Summary

The purpose of the study is to examine whether an investigational medication called ketamine along with psychotherapy is an effective treatment for depression in participants with a history of opioid addiction who have not abused opioids in at least 3 months. Participants will receive ketamine through intramuscular injection along with psychotherapy weekly for 8 weeks. Participation for eligible subjects who decide to enroll (including post-medication follow-up visits) will last about 16 weeks or 4 months.

Institution
MUSC
Recruitment Contact
Eric Dobson
843-729-1445
dobsoner@musc.edu

Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Treatment for Neonatal Opioid Withdrawal Syndrome

Date Added
February 7th, 2022
PRO Number
Pro00118200
Researcher
Dorothea Jenkins

List of Studies


Keywords
Infant, Pregnancy
Summary

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition in which infants undergo withdrawal after exposure to opioids in utero. The current standard of care uses oral morphine and/or methadone which can lead to harmful side effects in the infant. We propose a non-drug based, adjunct treatment that stimulates nerves around the ear, and may help reduce withdrawal symptoms while using less morphine.

Institution
MUSC
Recruitment Contact
Dorothea Jenkins
8437922112
jenkd@musc.edu

Studying the effects of iPACK blocks with adductor canal blocks for postoperative analgesia following ACL reconstruction

Date Added
June 21st, 2022
PRO Number
Pro00121103
Researcher
Carey Brewbaker

List of Studies


Keywords
Joint, Pain, Physical Therapy
Summary

This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.

Institution
MUSC
Recruitment Contact
Haley Nitchie
843-792-1869
nitchie@musc.edu



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