Clinical trials: Opioid Withdrawal
Opioid Withdrawal
Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal
A phase II double-blind placebo-controlled parallel group clinical trial that will randomize 90 subjects to investigate whether pregabalin (PGB) combined with Lofexidine (LFX) can reduce opioid withdrawal-related subjective…
- Trial name
- PGB-LOF (NCT04218240)
- Testing
- Pregabalin 200 MG capsules, Lofexidine 0.18Mg Tab
- Where
- 3 sites in United States
- Volunteers
- 90 people
- Sponsor
- University of Pennsylvania
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.
Opioid-Related Disorders, Drug Addiction
Medication Treatment for Opioid Use Disorder in Expectant Mothers
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and…
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse
- Trial name
- MOMs (NCT03918850)
- Testing
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Where
- 12 sites in United States
- Volunteers
- 140 people
- Sponsor
- T. John Winhusen, PhD
Pain
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film
The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine…
- Trial name
- NCT01871285
- Testing
- Buprenorphine, Oxycodone, Morphine sulfate
- Where
- 3 sites in United States
- Volunteers
- 39 people
- Sponsor
- BioDelivery Sciences International
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)
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
Opioid Use Disorder
NET Device for Treating Opioid Use Disorder
This prospective, randomized, double-blind, parallel-group, sham-controlled, superiority study will evaluate the effectiveness of the NET Device in treating persons with Opioid Use Disorder (OUD) without use of Medications for…
- Trial name
- NCT04916600
- Testing
- NET
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Wayne State University
Opioid Withdrawal, Physical Dependence
5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence
Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects (such as agitation and nausea) if opioid medications are suddenly stopped.
- Trial name
- NCT01549652
- Testing
- Ondansetron, Morphine, Naloxone 0.4 mg/70 kg
- Where
- United States
- Volunteers
- 133 people
- Sponsor
- Stanford University
Opioid Dependence, Opioid Withdrawal
Medical Management of Sleep Disturbance During Opioid Tapering
This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing…
- Conditions
- Opioid Dependence, Opioid Withdrawal, Sleep Disturbance
- Trial name
- NCT03789214
- Testing
- Low Dose Suvorexant, High Dose Suvorexant
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Johns Hopkins University
Opioid Abuse, Opioid Dependence
Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers
Opioid drugs increase glial cell activation which may be related to the abuse liability of opioid drugs. Data supporting this hypothesis have demonstrated that glial cell attenuators decrease the positive rewarding aspect of…
- Trial name
- NCT01740414
- Testing
- MN-166 (50 mg) First
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- New York State Psychiatric Institute
Opioid Dependence
Improving Buprenorphine Detoxification Outcomes With Isradipine
This application seeks to address the problem of opioid withdrawal by examining the utility of the L-type calcium channel blocker (CCB) isradipine as an adjunct to BUP detoxification.
- Trial name
- NCT01895270
- Testing
- Isradipine
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Arkansas
Cocaine Dependence, Opiate Dependence
Cocaine Withdrawal and Pharmacotherapy Response
A total of 120 male and female opioid dependent cocaine users will participate in this study. This study will be a 8-week double-blind, placebo controlled study examining the dose-dependent effects of carvedilol (up to 50 mg/day)…
- Trial name
- Carvedilol (NCT00566969)
- Testing
- sugar pill, Carvedilol 25 mg, Carvedilol 50 mg
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Yale University
Opioid-use Disorder
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
This is an open-label pilot trial to evaluate the safety and tolerability of lofexidine in the management of opioid withdrawal symptoms while initiating outpatient treatment with naltrexone.
- Trial name
- NCT04056182
- Testing
- Lofexidine 0.18 MG
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- New York State Psychiatric Institute
Opioid Use Disorder, Maternal Drugs Affecting Fetus
Night Respite for Postpartum Mothers With SUD
This single arm pilot feasibility study will evaluate the implementation of overnight infant respite care and parenting skills to mothers with substance use disorders in the early postpartum period residing in residential…
- Conditions
- Opioid Use Disorder, Maternal Drugs Affecting Fetus, Postpartum Mood Disturbance, Sleep Disorder
- Trial name
- NCT05746507
- Testing
- Night Respite Care
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- Massachusetts General Hospital
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
Improving Outcomes in Neonatal Abstinence Syndrome
1: SPECIFIC Aim I: To compare treatment options for neonatal abstinence syndrome (NAS) due to in-utero narcotic exposure. One hundred eighty four full-term infants with a diagnosis of NAS requiring medications will be studied.
- Trial name
- NCT01958476
- Testing
- Neonatal Morphine Solution, Methadone, Phenobarbital
- Where
- 8 sites in United States
- Volunteers
- 117 people
- Sponsor
- Tufts Medical Center
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
Substance Withdrawal Syndrome
Utility of Olanzapine in the Treatment of Opioid Withdrawal in the ED
Withdrawal from opioids is a clinical scenario that emergency department physicians encounter frequently. Patients who present with opioid withdrawal display symptoms such as agitation, anxiety, myalgias, abdominal pain…
- Trial name
- NCT02643355
- Testing
- Olanzapine, Clonidine
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hennepin Healthcare Research Institute
Substance-Related Disorders
Functional Magnetic Resonance Imaging of Opioid Withdrawal in Healthy Human Volunteers
Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped.
- Trial name
- NCT01006707
- Testing
- Ondansetron
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Stanford University
Opioid Withdrawal, Opioid Craving
Oral Cannabidiol for Opioid Withdrawal
This pilot study will examine the safety of the cannabinoid cannabidiol (Epidiolex) in a human laboratory model of clinically relevant withdrawal.
- Conditions
- Opioid Withdrawal, Opioid Craving, Opioid Use Disorder
- Trial name
- NCT04238754
- Testing
- Epidiolex
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Opioid Abuse, Opioid Dependence
A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone).
- Trial name
- NCT01136356
- Testing
- buprenorphine, morphine
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Johns Hopkins University