A pilot human laboratory study of cannabidiol in Alcohol Use Disorder Save

Date Added
March 5th, 2019
PRO Number
Pro00086168
Researcher
Joseph Schacht

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Profiles_link
Keywords
Alcohol, Drug Studies, Psychiatry
Summary

This study will examine the effects of Epidiolex among adults who drink alcohol heavily but who are not seeking treatment for their alcohol use. Epidiolex is an FDA-approved formulation of cannabidiol, the primary non-psychoactive constituent of cannabis. Participants in the study will be randomly assigned to take Epidiolex or placebo for 8 days. There are 3 study visits, including a day-long visit in the laboratory.

Institution
MUSC
Recruitment Contact
Katy Fuqua
(843) 792-1452
fuquama@musc.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 Save

Date Added
February 5th, 2019
PRO Number
Pro00084970
Researcher
Aimee Mc Rae

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Profiles_link
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

A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy, Then in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor-positive Advanced Breast Cancer Save

Date Added
January 22nd, 2019
PRO Number
Pro00084301
Researcher
Antonio Giordano

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Keywords
Cancer/Breast, Drug Studies, Women's Health
Summary

This is an open-label, nonrandomized, dose escalation and dose expansion, safety, efficacy, PK and PD evaluation study of SAR439859 administered orally as monotherapy, then in combination with palbociclib. The study will last approximately 26 months, and participation in the study may last 4 to 8 weeks or longer. The length of participation in this study will depend on how well subjects tolerate the study drug and the condition of their disease.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess the Efficacy and Safety of Apremilast (CC 10004) in Pediatric Subjects from 6 through 17 Years with Moderate to Severe Plaque Psoriasis Save

Date Added
January 22nd, 2019
PRO Number
Pro00084118
Researcher
Lara Wine lee

List of Studies

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Keywords
Drug Studies, Pediatrics, Skin
Summary

The purpose of this study is to test and compare the effects of an investigational (being tested) drug called apremilast to placebo in pediatric plaque psoriasis.
Participants who are determined to be eligible to participate will be assigned by chance (or randomized) to treatment with apermilast or placebo. At Week 16, participants will receive apremilast regardless of treatment group. Study and safety assessments, including questionnaires and blood draws, will be completed at study visits. The maximum amount of time participants will be in the study is 71 weeks (at least 19 visits).

Institution
MUSC
Recruitment Contact
Abby Powell
843-792-6690
powab@musc.edu

A Phase 2b, Open-Label, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of BST-236 as a Single Agent in Adults with Newly-Diagnosed Acute Myeloid Leukemia, Not Eligible for Standard Induction Therapy Save

Date Added
January 8th, 2019
PRO Number
Pro00083544
Researcher
Robert Stuart

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Profiles_link
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects with newly-diagnosed acute myeloid leukemia (AML) who are not eligible for standard induction chemotherapy. The investigational drug in this study is BST-236, which is given via IV. The purpose of this research study is to measure the safety of BST-236 and how effective it is in treating subjects. Visits will be required for 6 consecutive days during each cycle of treatment. The number of courses you receive will depend on whether you are benefiting from the study drug. Participants can expect to be in this study for 2 years (including treatment and post study follow-up).

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Spironolactone for the treatment of melasma: a prospective, open-label proof-of-concept and dose-ranging study Save

Date Added
December 4th, 2018
PRO Number
Pro00076765
Researcher
Dirk Elston

List of Studies


Profiles_link
Keywords
Drug Studies, Skin
Summary

The purpose of this study is to evaluate if the drug spironolactone - which is used to treat acne and male pattern hair growth in women - is effective in treating melasma in females and which dose of the drug works the best. Participation in this study will take about 5 clinic visits over approximately 16 weeks and the option to continue for longer if desired.

Institution
MUSC
Recruitment Contact
Den Lynch
843-876-5074
lynchd@musc.edu

FIGHT: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 3 Preceded by Dose-Finding in Phase 1 Save

Date Added
November 30th, 2018
PRO Number
Pro00079574
Researcher
Carolyn Britten

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Gastrointestinal, Drug Studies
Summary

The purpose of this study is to evaluate the safety and effectiveness of a new investigational compound, called FPA144, in combination with chemotherapy (a combination of 5-fluorouracil, oxaliplatin, and leucovorin called mFOLFOX6), for the treatment of gastric and/or gastroesophageal cancer and other solid tumors. The entire study (Phase 1 and Phase 3) is expected to take about 66 months to complete. MUSC is participating in the phase 3 portion only.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clincal-trials@musc.edu

A Phase Ib Open-Label, Dose-Finding Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Avelumab in Combination with M9241 (NHS-IL12) in Subjects with Locally Advanced, Unresectable, or Metastatic Solid Tumors Save

Date Added
November 27th, 2018
PRO Number
Pro00080265
Researcher
Carolyn Britten

List of Studies


Profiles_link
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to assess how effective the combination of avelumab and NHS-IL12 is in subjects with solid tumors. It will also collect more information on how safe and well-tolerated the combined study drugs are. Subjects will undergo a series of treatment cycles, each lasting 28 days. On Day 1 of each cycle, you will receive NHS IL12 immediately followed by avelumab on scheduled days. You will be assigned to receive avelumab every two weeks or to receive avelumab once a week. Both you and your study doctor will know which dose of study drugs you are receiving during the study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Save

Date Added
November 13th, 2018
PRO Number
Pro00083282
Researcher
Brian Hess

List of Studies

Silhouette
Keywords
Cancer, Cancer/Lymphoma, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with diffuse large B-cell lymphoma (DLBCL). The investigational drug in this study is loncastuximab tesirine (ADCT-402). The purpose of this Phase 2 study is to evaluate the effectiveness and safety of loncastuximab tesirine in subjects with DLBCL that has not responded to treatment or has come back after treatment.Treatment will occur every 3 weeks. The follow up treatment period will last up to approximately 3 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)ide Reverse Transcriptase Inhibitors (NRTI) plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants Save

Date Added
October 5th, 2018
PRO Number
Pro00081856
Researcher
Helmut Albrecht

List of Studies

Keywords
Drug Studies, HIV / AIDS, Infectious Diseases
Summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline regimen in HIV-1 infected, virologically suppressed African American participants.

Institution
Palmetto
Recruitment Contact
Helmut Albrecht
803-540-1000
ClinicalTrialSurvey@PalmettoHealth.org

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