Clinical trials: Withdrawal
Acute Leukemia, Acute Myeloid Leukemia
A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies
There is no curative therapy once acute leukemia patients relapse after transplant. Patients who develop clinically significant graft versus host disease (GVHD) have a lower rate of relapse than those who do not develop GVHD.
- Conditions
- Acute Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Biphenotypic Leukemia
- Trial name
- NCT01036009
- Testing
- Withdrawal of immunosuppression and donor lymphocyte infusion
- Where
- 2 sites in United States
- Volunteers
- 43 people
- Sponsor
- University of California, San Francisco
Nicotine Dependence
Nicotine Withdrawal Symptoms and Smoking Relapse
Background: Smoking is thought to cause changes in the brain that lead to addiction and craving. Smokers who try to quit experience nicotine withdrawal symptoms that include irritability, anxiety, and difficulty concentrating.
- Trial name
- NCT01511614
- Testing
- Transcranial Direct Current Stimulation, Nicotine patch, Varenicline Pill
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- National Institute on Drug Abuse (NIDA)
Cannabis Use Disorder, Cannabis Withdrawal
Progesterone for Cannabis Withdrawal
Sex and gender differences in behavioral, biological, and clinical correlates of substance use disorders are myriad, yet there exists a dearth of gender-informed treatment options.
- Trial name
- NCT03430050
- Testing
- Progesterone
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Medical University of South Carolina
Leptin Receptor Deficiency Obesity
Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity
To demonstrate statistically significant and clinically meaningful effects of setmelanotide on percent body weight change in participants with LEPR deficiency obesity due to rare bi-allelic or loss-of function mutations at the…
- Trial name
- NCT03287960
- Testing
- Setmelanotide
- Where
- 6 sites in Canada, France and 4 more
- Volunteers
- 15 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Opioid-Related Disorders, Opioid Dependence
An Innovative Intervention for OUD Treatment
The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment.
- Conditions
- Opioid-Related Disorders, Opioid Dependence, Opioid Addiction, Opioid Withdrawal
- Trial name
- Bridge (NCT04325659)
- Testing
- Bridge Device, Lofexidine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Opioid Withdrawal
Lofexidine for Adults Undergoing Lumbar Spine Surgery
The primary objective is to investigate the effects of lofexidine in adults undergoing opioid tapering prior to elective lumbar spine surgery.
- Trial name
- NCT04126083
- Testing
- Lofexidine Oral Tablet
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mayo Clinic
Chronic Low Back Pain
Phase 2 Chronic Low Back Pain Study
The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.
- Trial name
- NCT01364922
- Testing
- hydrocodone/acetaminophen extended release
- Where
- 17 sites in United States
- Volunteers
- 168 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Opioid Withdrawal
Open-Label, Safety Study of Lofexidine
The purpose of this Phase 3 open-label treatment study is to evaluate the safety and effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute withdrawal from any opioid, including methadone and…
- Trial name
- NU LEAF (NCT02363998)
- Testing
- Lofexidine
- Where
- 18 sites in United States
- Volunteers
- 286 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Sleep Disorder, Restless Legs Syndrome
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
The investigators propose to test the use of pramipexole in patients being treated for Opioid Use Disorder to test its ability to reduce symptoms of both Restless Legs Syndrome and protracted opioid withdrawal and thereby promote…
- Conditions
- Sleep Disorder, Restless Legs Syndrome, Opioid-use Disorder, Opioid Withdrawal
- Trial name
- NCT04759703
- Testing
- Pramipexole
- Where
- 2 sites in United States
- Volunteers
- 75 people
- Sponsor
- Massachusetts General Hospital
Marijuana Dependence
Ph1 Marinol Interaction Study - Part 2 - 1
This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the…
- Trial name
- NCT00490269
- Testing
- Dronabinol
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opioid Withdrawal (Disorder)
Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.
- Trial name
- TAPER (NCT04070157)
- Testing
- Lofexidine
- Where
- 12 sites in United States
- Volunteers
- 4 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Sarcoidosis
Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis
The purpose of this study is to compare the effectiveness and the safety of sarilumab in patients with glucocorticoid-dependent sarcoidosis.
- Trial name
- NCT04008069
- Testing
- Sarilumab
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Stanford University
Irritable Bowel Syndrome With Diarrhea
12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea.
- Trial name
- IRIS-3 (NCT02107196)
- Testing
- Ibodutant 10 mg
- Where
- 127 sites in United States, Bulgaria and 9 more
- Volunteers
- 535 people
- Sponsor
- Menarini Group
Kidney Transplant Recipients
Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients
This study is specifically designed to determine whether the initiation of Myfortic 2 weeks prior to transplantation will enhance the therapeutic efficacy of Simulect induction therapy in low to moderate risk patients.
- Trial name
- NCT01336296
- Testing
- mycophenolic acid
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of Cincinnati
Uterine Leiomyoma, Uterine Fibroids
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
The objectives of this randomized withdrawal study are to evaluate the long-term efficacy and safety of the combination of relugolix, estradiol (E2) and norethindrone acetate (NETA), once daily, for up to 104 weeks in patients…
- Trial name
- NCT03751124
- Testing
- Relugolix, Estradiol/norethindrone acetate
- Where
- 104 sites in United States, Brazil and 6 more
- Volunteers
- 229 people
- Sponsor
- Myovant Sciences GmbH
Systemic Lupus Erythematosus, SLE
Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)
This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.
- Trial name
- ALE06 (NCT01946880)
- Testing
- Mycophenolate Mofetil, Hydroxychloroquine or Chloroquine, Prednisone
- Where
- 19 sites in United States
- Volunteers
- 102 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Alagille Syndrome
Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)
This is a long-term, open-label study with a double-blind, placebo-controlled, randomized drug withdrawal period in children with Alagille Syndrome (ALGS) designed to evaluate the safety and efficacy of LUM001 (Also known as…
- Trial name
- ICONIC (NCT02160782)
- Testing
- LUM001 (Maralixibat)
- Where
- 9 sites in Australia, Belgium and 4 more
- Volunteers
- 31 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Pain, Peripheral Neuropathy
A Study to Compare the Safety and Tolerability of Sativex® in Patients With Neuropathic Pain.
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® in relieving neuropathic pain.
- Trial name
- NCT00713323
- Testing
- Sativex®
- Where
- United Kingdom
- Volunteers
- 380 people
- Sponsor
- Jazz Pharmaceuticals
Cannabis Use Disorder
Effect of Clonazepam on Cannabis Withdrawal and Relapse in Treatment-seeking Patients
The proposed protocol is a double-blind, placebo-controlled inpatient and outpatient study,looking at the clinical treatment of cannabis use disorder. The treatment study is a total of 12 weeks.
- Trial name
- NCT02913924
- Testing
- Clonazepam
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- New York State Psychiatric Institute