Clinical trials: Opiates
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
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
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
Infections, Human Immunodeficiency Virus and Hepatitis
Methadone-Dolutegravir (DTG - GSK1349572) Drug Interaction Study.
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of HIV infection.
- Trial name
- NCT01467518
- Testing
- Dolutegravir, Methadone
- Where
- Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Drug Overdose, Opioid-Related Disorders
Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose
RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the onset of mild, moderate, and…
- Trial name
- NCT03845699
- Testing
- Diagnostic algorithms that detects/predicts hypoventilation
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- RTM Vital Signs, LLC
Opiate Dependence
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults to assess the presence, duration, and degree of opiate blockade as well as the safety and tolerability of Medisorb® naltrexone…
- Trial name
- NCT01218984
- Testing
- Medisorb naltrexone 75 mg, Medisorb naltrexone 150 mg, Medisorb naltrexone 300 mg
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Healthy Subjects
Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.
To assess the combined effects of fosamprenavir 700mg BID + ritonavir 100mg BID + standardized dose of methadone, on plasma total and unbound methadone enantiomer pharmacokinetics (PK), opiate pharmacodynamic (PD) measures, and…
- Trial name
- NCT00481182
- Testing
- fosamprenavir + ritonavir + methadone
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Opiate Withdrawal Syndrome
A Study of Oral Ibogaine in Opioid Withdrawal
Study DMX-IB 201 is a Phase 1/2a study of ibogaine consisting of an initial single ascending dose escalation stage to determine the maximum tolerated dose (MTD) or treat-to-target dose (TTD) in healthy volunteers, followed by a…
- Trial name
- NCT05029401
- Testing
- DMX-1002
- Where
- 2 sites in United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- atai Therapeutics, Inc.
Opioid Overdose
Developing and Testing the Opioid Rapid Response System
This Phase I SBIR will develop and demonstrate the usability/feasibility of the Opioid Rapid Response System (OSSR) in order to reduce deaths and strain on emergency response systems from opioid overdoses.
- Trial name
- NCT04589676
- Testing
- Naloxone training
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Real Prevention, LLC
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
Opiate Induced Respiratory Depression
Antagonism of Opioid-Induced Respiratory Depression by CX1739 With Preservation of Opioid Analgesia
The study is an investigation to assess the capacity of ascending doses of CX1739 to antagonize the respiratory depressive effect of remifentanil.
- Trial name
- NCT02735629
- Testing
- CX1739 - 300 mg, CX1739 - 600 mg, CX1739 - 900 mg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- RespireRx
Opioid Overdose
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
- Trial name
- NCT05377255
- Testing
- 16 mg naloxone AP003, 8 mg naloxone NARCAN Nasal Spray
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Opioid Overdose, Opioid Use Disorder
Safety, Tolerability, and Pharmacokinetics of CSX-1004
This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult…
- Trial name
- NCT06005402
- Testing
- CSX-1004
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cessation Therapeutics, Inc.
Opioid Overdose
Pharmacokinetic (PK) Evaluation of Nalmefene Formulations
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
- Trial name
- NCT07543276
- Testing
- Nalmefene + 0.94% MgCl2, Nalmefene Hydrochloride Injection
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Knoa Pharma LLC
Pain, Acute Pain
A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure to Investigate the Safety and Tolerability of GRT0151Y and to Find Out Which Single Dose of the Compound is Maximally Tolerated
The purpose of this study is to determine the maximum dose of GRT0151Y that is tolerable and to explore the safety profile of the drug. For each Treatment Period (Visits 2-5), dosing will be separated by at least one week.
- Conditions
- Pain, Acute Pain, Chronic Pain
- Trial name
- NCT03765658
- Testing
- GRT0151Y dose escalation
- Where
- Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Opioid Overdose
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a single dose in each nostril and…
- Trial name
- NCT05219669
- Testing
- Nalmefene Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Opiant Pharmaceuticals Inc
Pain, Acute Pain
A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure Which Aims to Evaluate Whether GRT0151Y is Likely to be Abused
The purpose of this clinical study was to evaluate whether healthy adults, who sometimes take drugs for pleasure, are likely to abuse GRT0151Y. This abuse potential is assessed at three different doses of GRT0151Y.
- Trial name
- NCT03768024
- Testing
- GRT0151Y 50 mg capsule, Hydromorphone IR 4 mg
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Opiate Dependence
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under…
- Trial name
- NCT02477267
- Testing
- SL spray, SL film
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Healthy Volunteer Study
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
- Trial name
- NCT07314346
- Testing
- Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.