Clinical trials: Opioid
Opioid Use Disorder
Reward-based Technology to Improve OUD Treatment
Millions of people in the US misuse opioids each year. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common…
- Trial name
- OARSCM (NCT05180669)
- Testing
- OARSCM Software Application, MyMAT Software Application
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Q2i, LLC
Recreational Drug Use
A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104)
This will be a randomized, double-blind, placebo- and active-controlled, 5-way crossover study to evaluate the abuse potential, safety and pharmacokinetics of orally administered PF614 relative to oxycodone IR (immediate-release)…
- Trial name
- NCT05571345
- Testing
- PF614, Oxycodone Hydrochloride 40 mg
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Ensysce Biosciences
Pain, Analgesics, Opioid
A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain
The purpose of this study was to characterize the steady-state pharmacokinetic (metabolism and action) profile of OROS hydromorphone HCI (slow release) in patients who required opioid therapy on a daily basis for chronic pain…
- Trial name
- NCT00410878
- Testing
- OROS Hydromorphone HCI (slow release)
- Volunteers
- 22 people
- Sponsor
- Alza Corporation, DE, USA
Healthy
To Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted…
- Trial name
- NCT01101321
- Testing
- Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Advance Illness Patients With OIC
Study of Methylnaltrexone (MNTX) for the Relief of Constipation
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.
- Trial name
- NCT00402038
- Testing
- SC Methylnaltrexone
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid Overdose
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into…
- Trial name
- NCT06719986
- Testing
- Nalmefene HCl injection, Naloxone HCl intranasal
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Patients With Opioid Induced Constipation
Longitudinal Study of Patients With Opioid-Induced Constipation
This prospective hybrid longitudinal study was conducted in the United States (US), Canada, the United Kingdom (UK), and Germany.
- Trial name
- NCT01928953
- Where
- 30 sites in United States, Canada
- Volunteers
- 520 people
- Sponsor
- AstraZeneca
Low Back Pain
Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets
This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe chronic low back pain who require continuous…
- Trial name
- NCT01922739
- Testing
- Hydrocodone ER
- Where
- 61 sites in United States
- Volunteers
- 182 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Opioid-use Disorder
Technology for MAT in Primary Care - Phase 2
With over 72,000 overdose deaths in 2017, of which 47,600 are attributable to opioid overdose, the opioid epidemic has become North America's most widespread behavioral public health problem.
- Trial name
- NCT05017272
- Testing
- Opioid Addiction Recovery Support Software Platform
- Where
- United States
- Volunteers
- 246 people
- Sponsor
- Q2i, LLC
Opioid-use Disorder
Heterodyned Whole-Body Vibration in Treatment of Opioid Withdrawal-Induced Anxiety
In this randomized, double-blind, controlled, parallel group study (conducted over 12-months), enrollment is expected of up to 60 subjects (30 men and 30 women) ages 18+ who are currently going through withdrawal of OUD and being…
- Trial name
- NCT05056753
- Testing
- HWBV chair
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- PhotoPharmics, Inc.
Insomnia
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep.
- Trial name
- NCT06655883
- Testing
- Suvorexant
- Where
- 13 sites in United States
- Volunteers
- 300 people
- Sponsor
- Merck Sharp & Dohme LLC
Postoperative Pain
Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy Patients
This is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of Q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate…
- Trial name
- NCT01280331
- Testing
- Q8003 (morphine sulfate and oxycodone hydrochloride), Morphine sulfate, Oxycodone HCl
- Where
- 4 sites in United States
- Volunteers
- 375 people
- Sponsor
- QRxPharma Inc.
Chronic Pain
A Study of JNS020QD in Patients With Chronic Pain
The purpose of this study is to evaluate the efficacy and safety of JNS020QD in patients with moderate to severe chronic pain who switched from opioid analgesics, as well as the safety and efficacy of long-term treatment (52…
- Trial name
- NCT01493245
- Testing
- JNS020QD
- Where
- 18 sites in Japan
- Volunteers
- 77 people
- Sponsor
- Janssen Pharmaceutical K.K.
Opioid Overdose
Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics
Retrospective study to assess incidence and predictors of opioid abuse overdose and death associated with opioid overdose among patients prescribed opioid products in long-term use.
- Trial name
- NCT02662153
- Testing
- Observation only
- Where
- 4 sites in United States
- Volunteers
- 808,455 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M)
A Phase II Trial for MOR Antagonism With Axelopran to Enhance Immunotherapy in Head and Neck Cancer
This Phase 2, open-label, multicenter study will evaluate the safety and preliminary efficacy of axelopran in combination with pembrolizumab in patients with PD-L1 positive recurrent or metastatic head and neck squamous cell…
- Trial name
- MORALE-HN01 (NCT07662720)
- Testing
- axelopran, Pembolizumab
- Volunteers
- 18 people
- Sponsor
- Glycyx Therapeutics
Breakthrough Pain, Cancer
Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.
- Trial name
- ETHYFYL (NCT01842893)
- Testing
- Fentanyl Ethypharm
- Where
- Czechia
- Volunteers
- 91 people
- Sponsor
- Ethypharm
Chronic Pain
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.
- Trial name
- NCT01206907
- Testing
- oxymorphone IR
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Osteoarthritis, Rheumatoid Arthritis
Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain
The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of moderate to severe intensity due to…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Lower Back Pain, Joint Pain
- Trial name
- NCT01961271
- Testing
- Buprenorphine transdermal patch
- Where
- 16 sites in Hong Kong, Philippines and 1 more
- Volunteers
- 114 people
- Sponsor
- Mundipharma Pte Ltd.
Addiction, Opioid Dependence
Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction
The purpose of this study is determine the safety, efficacy and tolerability of a novel drug APH-1501 as a pharmacotherapy for Opioid Dependence. The investigators will evaluate the safety of escalating doses APH-1501.
- Conditions
- Addiction, Opioid Dependence, Opioid Withdrawal
- Trial name
- NCT03813095
- Testing
- APH-1501
- Volunteers
- 32 people
- Sponsor
- Aphios
Opioid-induced Bowel Dysfunction
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
- Trial name
- NCT01298219
- Testing
- Lubiprostone
- Where
- 142 sites in United States, Belgium and 5 more
- Volunteers
- 439 people
- Sponsor
- Sucampo Pharma Americas, LLC