Clinical trials: Opioids
Substance Withdrawal Syndrome
Signs and Symptoms of Opioid-associated Iatrogenic Withdrawal in Critically Ill Adults
Mechanically ventilated critically ill adults may require prolonged administration of opioids to facilitate ventilator support and maintain comfort.
- Trial name
- SOWA-ICU (NCT03435614)
- Testing
- Opioids
- Where
- Canada
- Volunteers
- 29 people
- Sponsor
- Marc M. Perreault
Low Back Pain
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid…
- Trial name
- NCT01358526
- Testing
- Oxycodone/Naloxone Controlled-release
- Where
- 151 sites in United States
- Volunteers
- 1,095 people
- Sponsor
- Purdue Pharma LP
Pain, Hernia
Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy
This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with…
- Trial name
- NCT02929589
- Testing
- Ibuprofen, Opioid Medication, Ibuprofen + Opioid medication
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Mike O'Callaghan Military Hospital
Opioid Dependence, Chronic Pain
Feasibility and Preliminary Efficacy of an Opioid Stewardship Program in Hospitalized Patients With Chronic Pain
This study aims to investigate the feasibility and preliminary efficacy of an enhanced opioid stewardship program, tailored to the needs of hospitalized patients with chronic pain with opioid dependence, incorporating real-time…
- Trial name
- NCT05370326
- Testing
- Enhanced Opioid Stewardship Program
- Where
- 2 sites in United States
- Volunteers
- 52 people
- Sponsor
- Yale University
Substance Use Disorders
Benzodiazepine Discontinuation in Opioid Agonist Therapy
The proposed study is a clinical trial, designed to pilot test a Distress Tolerance-Benzodiazepine Discontinuation (DT-BD) intervention for patients on opioid agonist therapy who currently use benzodiazepines.
- Trial name
- BZD-OAT (NCT04109118)
- Testing
- Distress Tolerance - Benzodiazepine Discontinuation (DT-BD), BZD discontinuation protocol
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Boston Medical Center
Opioid-Induced Constipation (OIC)
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.
- Trial name
- NCT01395524
- Testing
- NKTR-118
- Where
- 116 sites in United States, Australia and 2 more
- Volunteers
- 302 people
- Sponsor
- AstraZeneca
Opiate Dependence, Substance-related Disorders
Prescription Opioid Addiction Treatment Study (POATS)
The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with…
- Conditions
- Opiate Dependence, Substance-related Disorders, Opioid-related Disorders
- Trial name
- NCT00316277
- Testing
- Standard Medical Management (SMM) of Prescription Opiate Abuse, Enhanced Medical Management (EMM) of Prescription Opiate Abuse
- Where
- 12 sites in United States
- Volunteers
- 653 people
- Sponsor
- Mclean Hospital
Moderate to Severe Chronic Pain
A Study Using fMRI Imaging to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users.
The main purpose of this study is to evaluate the effect of NKTR-181 on brain activity in healthy, non-physically dependent recreational opioid users. This study will last about 88 days for each participant.
- Trial name
- NCT03802227
- Testing
- NKTR-181, Oxycodone IR
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Nektar Therapeutics
Chronic Pain, Opiate Dependence
Developing Brain Stimulation as a Treatment for Chronic Pain in Opiate Dependent
Effective control of chronic pain is a top priority in the United States, as approximately 10% of adults have severe chronic pain - most of which is chronic lower back pain (CLBP).
- Conditions
- Chronic Pain, Opiate Dependence, Lower Back Pain
- Trial name
- NCT03681769
- Testing
- iTBS to the left dlPFC, cTBS to the mPFC
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Medical University of South Carolina
Constipation
Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain
The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain…
- Trial name
- NCT00605644
- Testing
- MOA-728
- Volunteers
- 128 people
- Sponsor
- Bausch Health Americas, Inc.
Pain
Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
The purpose of this study is to see if the drug, Dexmedetomidine (also known as Precedex), can reduce pain for patients having Thoracic Surgery and therefore reduce the amount of opioid drug needed after surgery.
- Trial name
- NCT01973452
- Testing
- Dexmedetomidine
- Where
- 4 sites in United States
- Volunteers
- 333 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Pain, Cancer
A Phase 2a, Proof-of-Concept Study of GIC-1001 in the Management of Visceral Pain During Sedation-Free, Full Colonoscopy
GIC-1001 is a novel, orally-administered, colonic analgesic drug developed as an alternative to i.v. sedation during full colonoscopy.
- Conditions
- Pain, Cancer, Colonic Diseases
- Trial name
- NCT01926444
- Testing
- GIC-1001
- Where
- 15 sites in United States, Canada
- Volunteers
- 308 people
- Sponsor
- gicare Pharma Inc.
Chronic Pain
Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
This pediatric study is designed to provide safety information, dosing guidelines, and a pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl) extended-release (ER) tablets in children with chronic…
- Trial name
- NCT02321319
- Testing
- Hydromorphone HCl ER Tablets
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Mallinckrodt
Contraception
Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT)
Recent research suggests that women with substance use disorders may be at a higher risk of unintended pregnancy. There is a paucity of interventions specifically focused on this population.
- Trial name
- NCT02794597
- Testing
- SHINE intervention group
- Where
- United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Denver Health and Hospital Authority
Opioid Abuse
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid…
- Trial name
- NCT00699010
- Testing
- Acurox 5/30mg taken first, Oxycodone 5mg taken first
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acura Pharmaceuticals Inc.
Postoperative Pain
Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery
The primary purpose of this study is to determine if CR845 is effective in treating the pain associated with a laparoscopic hysterectomy.
- Trial name
- NCT01361568
- Testing
- CR845
- Where
- 18 sites in United States
- Volunteers
- 203 people
- Sponsor
- Cara Therapeutics, Inc.
Neonatal Abstinence Syndrome
Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was associated with a ~30% reduction length of treatment…
- Trial name
- NCT01452789
- Testing
- sublingual buprenorphine, oral morphine
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Thomas Jefferson University
Opiate Dependence
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
- Trial name
- NCT00834080
- Testing
- Medisorb naltrexone 380 mg
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Alkermes, Inc.
Drug Dependence
Extended Release Naltrexone for Opioid-Dependent Youth
The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).
- Trial name
- NCT01843023
- Testing
- Extended Release Naltrexone, Psychosocial Treatment, Buprenorphine
- Where
- 2 sites in United States
- Volunteers
- 288 people
- Sponsor
- Friends Research Institute, Inc.
Methamphetamine Abuse, Opioid-use Disorder
Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics
The investigators propose to develop and evaluate optimal combinations of evidence-based interventions to improve HIV outcomes and reduce methamphetamine use (hereafter: meth use) among people with opioid use disorder who are in…
- Conditions
- Methamphetamine Abuse, Opioid-use Disorder, HIV Seropositivity
- Trial name
- STAR-OM (NCT04706624)
- Testing
- Contingency management (12 weeks), Contingency management (6 weeks), SMS reminders
- Where
- 4 sites in Vietnam
- Volunteers
- 667 people
- Sponsor
- Hanoi Medical University