Clinical trials: Drug Withdrawal
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)
Hyperkalemia
Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.
- Trial name
- DIAMOND (NCT03888066)
- Testing
- Patiromer
- Where
- 415 sites in United States, Argentina and 19 more
- Volunteers
- 1,195 people
- Sponsor
- Vifor Pharma, Inc.
Opioid Dependence, Acute Opioid Withdrawal Syndrome
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.
- Trial name
- NCT01863186
- Testing
- Lofexidine HCl, Open Label Lofexidine HCL
- Where
- 18 sites in United States
- Volunteers
- 603 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Tardive Dyskinesia (TD)
The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.
- Trial name
- NCT03698331
- Testing
- Valbenazine
- Where
- 17 sites in United States, Puerto Rico
- Volunteers
- 89 people
- Sponsor
- Neurocrine Biosciences
Neuralgia, Postherpetic, Diabetic Neuropathy
Neuropathic Pain Syndrome Patient Study (MK-0000-072)
The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
- Conditions
- Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy, Idiopathic Distal Sensory Polyneuropathy
- Trial name
- NCT00570310
- Testing
- Comparator: pregabalin
- Volunteers
- 104 people
- Sponsor
- Merck Sharp & Dohme LLC
Neonatal Opioid Withdrawal Syndrome
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
- Trial name
- NOWSHINE (NCT04104646)
- Testing
- CHF6563, Morphine
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Pain, Low Back Pain
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
- Conditions
- Chronic Pain, Low Back Pain, Analgesia
- Trial name
- NCT01571362
- Testing
- ALO-02
- Where
- 52 sites in United States
- Volunteers
- 410 people
- Sponsor
- Pfizer
Chronic Pain
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
- Trial name
- NCT01100437
- Testing
- EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush, EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Pfizer
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)
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.
Opioid Withdrawal
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance.
- Trial name
- NCT04470050
- Testing
- Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 225 people
- Sponsor
- BioXcel Therapeutics Inc
Narcolepsy Type 1 (NT 1)
A Study of TAK-994 in Adults With Narcolepsy
Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study. The main aim of this study is to check if participants have side effects from TAK-994.
- Trial name
- NCT04820842
- Testing
- TAK-994
- Where
- 70 sites in United States, Canada and 8 more
- Volunteers
- 26 people
- Sponsor
- Takeda
de Novo Kidney Transplant Recipients, Renal Transplantation
Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.
This study will compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid…
- Trial name
- EVIDENCE (NCT01023815)
- Testing
- everolimus, cyclosporine, Prednison (continuous steroids)
- Where
- 28 sites in Italy
- Volunteers
- 330 people
- Sponsor
- Novartis
Attention Deficit Hyperactivity Disorder
A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD).
- Trial name
- NCT00700427
- Testing
- atomoxetine hydrochloride
- Where
- 56 sites in Austria, Belgium and 10 more
- Volunteers
- 2,017 people
- Sponsor
- Eli Lilly and Company
Juvenile Idiopathic Arthritis
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to…
- Trial name
- NCT01230827
- Testing
- CNTO 148 (Golimumab), Methotrexate
- Where
- 35 sites in United States, Austria and 10 more
- Volunteers
- 173 people
- Sponsor
- Janssen Research & Development, LLC
Tardive Dyskinesia (TD)
Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.
- Trial name
- NCT03891862
- Testing
- Valbenazine
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 135 people
- Sponsor
- Neurocrine Biosciences
Psoriatic Arthritis
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.
- Trial name
- SPIRIT P3 (NCT02584855)
- Testing
- Ixekizumab
- Where
- 106 sites in United States, Bulgaria and 10 more
- Volunteers
- 394 people
- Sponsor
- Eli Lilly and Company
Epilepsy
eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel…
- Trial name
- VERVE (NCT01484977)
- Testing
- Lacosamide
- Where
- 54 sites in United States, Australia and 7 more
- Volunteers
- 120 people
- Sponsor
- UCB Pharma
Schizophrenia and Predominant Negative Symptoms
Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as…
- Trial name
- NCT00922272
- Testing
- SPD489 (lisdexamfetamine dimesylate)
- Where
- 27 sites in United States
- Volunteers
- 92 people
- Sponsor
- Shire
Psoriasis
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.
- Trial name
- POETYK-PSO-2 (NCT03611751)
- Testing
- BMS-986165, Apremilast
- Where
- 205 sites in United States, Australia and 14 more
- Volunteers
- 1,020 people
- Sponsor
- Bristol-Myers Squibb