Clinical trials: Opioid-Related Disorders
Substance Withdrawal Syndrome, Opiate Addiction
Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction
The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.
- Conditions
- Substance Withdrawal Syndrome, Opiate Addiction, Opiate Dependence
- Trial name
- NCT02801357
- Testing
- lofexidine administration in subjects seeking buprenorphine dose reduction
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opioid Use Disorder
A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders.
Investigators will test, for safety and efficacy, a novel treatment for opiate addiction that applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain that the investigators determine to be…
- Trial name
- NCT05995873
- Testing
- transcranial photobiomodulation at 810 nm at 250 mW/cm2 for 4 minutes
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- MindLight, LLC
Opioid Dependency
Effectiveness of Buprenorphine/Naloxone in Reducing Intravenous Buprenorphine Misuse in France ("RIME")
Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based…
- Trial name
- RIME (NCT00955162)
- Testing
- Buprenorphine (Subutex), Buprenorphine/naloxone (Suboxone)
- Where
- 20 sites in France
- Volunteers
- 270 people
- Sponsor
- Indivior Inc.
Abuse, Drug
A Trial to Evaluate the Abuse Potential of 3 Doses of GRT6005 in Adult Non-dependent Recreational Opioid Users
The primary objective of this study was to evaluate the abuse potential of single doses of cebranopadol (GRT6005) relative to hydromorphone (immediate-release formulation [IR] and placebo in 48 non-dependent recreational opioid…
- Trial name
- NCT03757559
- Testing
- Cebranopadol 100 micrograms, Cebranopadol 400 micrograms, Hydromorphone hydrochloride 4 milligrams
- Where
- Canada
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- Tris Pharma, Inc.
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)
Opioid-Induced Constipation
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.
- Trial name
- NCT01901302
- Testing
- CB-5945
- Volunteers
- 61 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Opioid-use Disorder
OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC)…
- Trial name
- NCT04948307
- Testing
- OXD01 digital therapy, Standard of Care
- Where
- 21 sites in United States
- Volunteers
- 437 people
- Sponsor
- Orexo AB
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
Opioid Induced Constipation
Naloxegol US PMR CV Safety.
The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of cancer and who are treated with opioids chronically
- Trial name
- NCT02813356
- Testing
- naloxegol, non-PAMORA
- Where
- 2 sites in United States
- Volunteers
- 8,800 people
- Sponsor
- Valinor Pharma LLC
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
Hepatitis C, Opioid-Related Disorders
Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
The purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will help to determine whether buprenorphine dose…
- Trial name
- NCT01275599
- Testing
- telaprevir, buprenorphine/naloxone
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Opioid-Induced Constipation (OIC)
Assessment of Efficacy and Safety 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, including those patients that have inadequate response to laxative…
- Trial name
- NCT01309841
- Testing
- NKTR-118
- Where
- 117 sites in United States, Australia and 2 more
- Volunteers
- 652 people
- Sponsor
- AstraZeneca
Opioid Dependence, on Agonist Therapy
Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent…
- Trial name
- NCT01903005
- Testing
- Higher bioavailability BNX sublingual tablets
- Where
- 28 sites in United States
- Volunteers
- 668 people
- Sponsor
- Orexo AB
Opioid Dependence, on Agonist Therapy
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared…
- Trial name
- ISTART (NCT01908842)
- Testing
- BNX sublingual tablets, BNX sublingual film, Buprenorphine
- Where
- 36 sites in United States
- Volunteers
- 759 people
- Sponsor
- Orexo AB
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
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
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.
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
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