Clinical trials: Opioid Withdrawal (Disorder)
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
Tobacco Use Disorder
Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers
This study will examine extended exposure to cigarettes varying in nicotine content among adults with opioid use disorder. Those with opioid use disorder are at increased risk for smoking, nicotine dependence, and using high…
- Trial name
- P2S2 (NCT02250664)
- Testing
- Very low nicotine content cigarettes
- Where
- 2 sites in United States
- Volunteers
- 775 people, healthy volunteers welcome
- Sponsor
- University of Vermont
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
Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine.
- Trial name
- B-PHORE (NCT03608696)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University
Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal
Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.
- Conditions
- Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
- Trial name
- NCT04298853
- Testing
- Morphine PRN, Morphine scheduled
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Indiana University
Osteoarthritis of the Knee
A Phase 2 Study To Assess The Efficacy, Tolerability, And Safety OF NKTR-181 In Subjects With Chronic OA Knee Pain
NKTR-181 is being developed as an analgesic compound for the treatment of moderate to severe chronic pain - active as a mu agonist, but with inherent molecular properties designed to provide a unique clinical profile, including…
- Trial name
- NCT01619839
- Testing
- NKTR-181
- Where
- 34 sites in United States
- Volunteers
- 296 people
- Sponsor
- Nektar Therapeutics
Opioid-Related Disorders
Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal
Repeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration.
- Trial name
- AV411 (NCT00723177)
- Testing
- AV411
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
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-Use Disorder
Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
Background: People with opioid-use disorder (OUD) might benefit from having more treatment drugs to choose from. A new drug, TRV734, could be used like methadone to treat OUD. It might not have as many side effects.
- Trial name
- NCT04316559
- Testing
- TRV734, Oxycodone
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- National Institute on Drug Abuse (NIDA)
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
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
Substance-Related Disorders, Substance Use Disorders
Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders
Subjects in this study will be patients with opioid use disorders (OUDs) based on DSM-5 criteria recruited from the greater Atlanta metropolitan region.
- Conditions
- Substance-Related Disorders, Substance Use Disorders, Substance Abuse, Intravenous, Substance Withdrawal
- Trial name
- nVNS in OUDs (NCT04556552)
- Testing
- Non invasive VN stimulation (nVNS), Oxygen (15-O) Water
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Emory University
Opioid-related Disorders
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active…
- Trial name
- NCT00637000
- Testing
- Buprenorphine soluble film, Buprenorphine/naloxone film strip
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Indivior Inc.
Tobacco Use Disorder
Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder
Prevalence of smoking among individuals with opioid use disorder (OUD) is six-fold that of the general US adult population. The mortality rate of opioid-dependent smokers is four times that of opioid-dependent nonsmokers, and…
- Trial name
- NCT04092101
- Testing
- Cigarettes with varying nicotine content, E-Cigarettes
- Where
- 2 sites in United States
- Volunteers
- 326 people, healthy volunteers welcome
- Sponsor
- University of Vermont
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)
Neonatal Abstinence Syndrome
Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants
Thousands of critically ill infants (and children) are exposed to opioids and benzodiazepines to achieve sedation and analgesia as part of routine care in neonatal and pediatric intensive care units.
- Trial name
- NCT01360450
- Testing
- Clonidine HCL, saline
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Johns Hopkins University
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
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 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
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