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, controlled 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

An Exploratory Investigation Utilizing Repetitive Transcranial Magnetic Stimulation (rTMS) as a Tool to Decrease Pain and Improve Functioning in Veterans with Opioid Use Disorder

Date Added
February 5th, 2019
PRO Number
Pro00084970
Researcher
Aimee McRae-Clark

List of Studies


Keywords
Drug Studies, Substance Use
Summary

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS) reduces opiate craving and pain in Veterans who are receiving treatment for opioid use disorder. The study will last approximately three months. There will be a screening visit to determine eligibility, followed by the treatment phase during which participants will receive six sessions of rTMS a day for three non-consecutive days. This period may take up to three weeks. There are follow up visits at one week, four weeks and three months after the treatment phase has ended.
During rTMS, focused magnetic waves are directed at a part of the brain that is important in pain, and craving, to increase its activity. If you participate, you will receive six sessions of either active rTMS, or placebo rTMS, each day for three days (18 total sessions). Each session lasts 15 minutes. People typically do not have side effects with rTMS, though they initially may find it mildly painful at the application site. About 1 out of every 20 people who get rTMS have mild headaches after sessions that are typically relieved with over-the-counter medicines. A few people who have had rTMS have had seizures, though the chance of this happening is very small.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@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

Sex Differences in the Effects of Early Childhood Adversity on Laboratory-Induced Stress and Craving among Individuals with Opioid Use Disorder

Date Added
February 2nd, 2021
PRO Number
Pro00104087
Researcher
Delisa Brown

List of Studies


Keywords
Drug Studies, Pain, Psychiatry, Stress Disorders, Substance Use
Summary

This study will examine the effects of early childhood adversity on stress and craving among individuals with opioid use disorder. Study participants will complete a total of three visits, including a 1-month follow-up visit. Participants will be asked to complete questionnaires about thier mood, anxiety, drug use, craving and adverse childhood events. They will listen to personalized scripts about a stressful situation, a time when they used opioid and a relaxing situation and their heart rate, skin conductance and cortisol are measured.

Institution
MUSC
Recruitment Contact
Delisa Brown
843-792-2388
browdg@musc.edu

Disentangling Reward/Anti-reward Circuits in Opioid Users with Chronic Low Back Pain

Date Added
May 18th, 2021
PRO Number
Pro00106192
Researcher
Catherine Hubbard

List of Studies


Keywords
Brain, Drug Studies, Pain
Summary

This project uses advanced analytical approaches in functional magnetic resonance imaging, at the level of the individual, to expand our current understanding of the brain changes responsible for driving an individual's susceptibility or resistance toward prescription opioid misuse in patients with chronic low back pain.

Institution
MUSC
Recruitment Contact
Catherine Hubbard
843-792-9502
precisionimaginglab@musc.edu

Integrated Treatment for Women with Co-Occurring Opioid Use Disorder and Posttraumatic Stress Disorder

Date Added
July 16th, 2021
PRO Number
Pro00111570
Researcher
Tanya Saraiya

List of Studies

Keywords
Psychiatry, Women's Health
Summary

We are seeking people who have used or currently use opioids, are between the ages of 18-65, and a have experienced a traumatic event. A traumatic event is something incredibly frightening, such as physical assault, domestic violence, or sexual assault. We will interview participants for their preferences in treatment for 60-90 minutes. Interviews are confidential. Participants will be compensated $25 for their time.

Institution
MUSC
Recruitment Contact
Tanya Saraiya
347 961 8252
saraiya@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



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