Clinical trials: Opioids
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
Opioid Overdose
Naloxone Nasal Spray Pharmacokinetic Study
This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization…
- Trial name
- NCT01622504
- Testing
- MVP005, Naloxone hydrochloride solution for injection with mucosal atomization device
- Where
- Jordan
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Mitovie Pharma Ltd
Constipation
TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects
The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated by the body and to evaluate whether it is safe and well tolerated.
- Trial name
- NCT01655771
- Testing
- TD-1211 Dose 1, TD-1211 Dose 2
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Glycyx Therapeutics
Drug Abuse
A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users
The purpose of this study is to assess the relative abuse potential of the hydrocodone bitartrate extended-release tablet compared to immediate-release hydrocodone bitartrate.
- Trial name
- NCT01596673
- Testing
- 45-mg hydrocodone bitartrate extended-release tablet (crushed or intact)
- Where
- 2 sites in United States, Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Cephalon
Healthy
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users
The purpose of the present study is to assess prospectively the abuse potential of gabapentin when taken with and without oxycodone compared to placebo in healthy non-drug-dependent recreational opioid drug users under fasted…
- Trial name
- NCT07813026
- Testing
- Oxycodone 20mg, gabapentin 600 mg, Gabapentin 1200mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Viatris Inc.
Chronic Pain
Dronabinol Opioid Sparing Evaluation (DOSE) Trial
This study will be a 12-week, open-label trial that is designed to evaluate the Opioid-Sparing effect of Dronabinol at ranging doses when coadministered with the opioid analgesics that are currently being prescribed to patients…
- Trial name
- NCT03766269
- Testing
- Dronabinol
- Where
- United States
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Daisy Pharma Opioid Venture, LLC
Opioid Overdose
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.
- Trial name
- NCT04713709
- Testing
- Nasus Pharma FMXIN001, Nasal Naloxone liquid spray
- Where
- Canada
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Nasus Pharma
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
Opioid-use Disorder
Study of a Novel Subcutaneous Depot Formulation of Buprenorphine
INDV-6200 is being developed for the treatment of opioid dependency and is expected to provide sustained buprenorphine plasma concentrations.
- Trial name
- NCT03715634
- Testing
- INDV-6200, SL Buprenorphine, Nalorex
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
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.
Prescription Opioid Misuse
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
The goal of this study is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention.
- Trial name
- NCT05209191
- Testing
- Student Athlete Wellness Portal
- Where
- 5 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Real Prevention, LLC
Healthy
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fasted state.
- Trial name
- NCT01101191
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Nalbuphine, Opioid Abuse
Oral Abuse Potential Study of Nalbuphine
The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients).
- Trial name
- NCT04018664
- Testing
- Nalbuphine HCl solution
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Trevi Therapeutics
Osteoarthritis, Hip, Osteoarthritis, Knee
A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis
The purpose of this study was to compare the analgesic (a drug that relieves pain) effectiveness and safety of OROS hydromorphone HCI (slow release) 8 mg and 16 mg to placebo (no drug) in patients with osteoarthritis (OA).
- Trial name
- NCT00411164
- Testing
- OROS hydromorphone HCI (slow release)
- Volunteers
- 990 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA
Opioid Overdose
Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers
The study consists of two Phases with the first phase (Pilot Phase) divided into two sub phases. In each study phase, subjects will be admitted to the clinical unit from 10 hours prior to the first drug administration on Day -1…
- Trial name
- NCT05363501
- Testing
- IM Naloxone Injection, Naloxone Nasal Spray, Naloxone Nasal Swab
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pocket Naloxone Corp
ECG Effects
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers
The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
- Trial name
- NCT01999114
- Testing
- Buprenorphine transdermal patch, Naltrexone tablet, Moxifloxacin tablet
- Where
- United States
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Respiratory Depression
Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo.
The purpose of this study is to explore and compare VRH after administration of Belbuca, Oxycodone HCl and Placebo in recreational opioid users.
- Trial name
- NCT03996694
- Testing
- Belbuca 300 µg, Belbuca 600 µg, Belbuca 900 µg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- BioDelivery Sciences International
Opioid Abuse Nondependent
Nasal Human Abuse Potential of PTI-821
The study will evaluate the human abuse liability of PTI-821 (oxycodone extended-release capsules) when administered nasally compared to crushed oxycodone IR tablets and crushed OxyContin tablets, also administered nasally.
- Trial name
- NCT03475862
- Testing
- PTI-821 capsule Manipulated, PTI-821 Non-manipulated, OxyContin
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Pain Therapeutics
Opioid Withdrawal, Pain
BRIDGE Device for Treatment of Opioid Withdrawal
The purpose of this study is to prospectively evaluate the effectiveness of the NSS-2 BRIDGE device in reducing the signs and symptoms of acute opioid withdrawal when compared to placebo.
- Conditions
- Opioid Withdrawal, Pain, Craving
- Trial name
- NCT04162145
- Testing
- Active BRIDGE device placement, Inactive BRIDGE device placement
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- BrightView LLC
Chronic Pain, Arthritis Hand
Effects of the Nottingham Augmented Reality (AR) App for Arthritis Hand Joint Pain
The aim of this run-in design, feasibility study is to assess outcomes (including opioid-use, pain intensity, emotional function, and general physical function) for an augmented reality illusion therapy in participants with…
- Conditions
- Chronic Pain, Arthritis Hand, Opioid Use
- Trial name
- NCT05634291
- Testing
- Standard of care, Nottingham AR smartphone app with active intervention
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- VRx Medical Inc