Clinical trials: Opioid Use Disorders
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.
Opioid Use Disorder
iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers
This Phase 1b clinical study is evaluating iSTEP-N, an investigational extended-release implant containing naltrexone, a medication used to block the effects of opioids.
- Trial name
- iSTEP-N (NCT07064564)
- Testing
- Naltrexone implant, 14.4 grams, Naltrexone implant, 9.6 grams, Extended-release naltrexone injection, 380 mg
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Akyso Therapeutics, LLC
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 Use Disorder, Severe, Opioid Use Disorder, Moderate
SUBLOCADE Rapid Initiation Extension Study
A single center, open-label SUBLOCADE treatment extension study in which up to 25 participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.
- Trial name
- NCT04060654
- Testing
- Sublocade
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Indivior Inc.
Osteoarthritis, Pain
Study of Efficacy, Safety of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3001
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy compared with placebo in participants with chronic moderate to severe pain and functional impairment from knee…
- Trial name
- NCT02336685
- Testing
- Fulranumab 1 mg, Fulranumab 3 mg, Opioid
- Where
- 53 sites in United States, Canada and 4 more
- Volunteers
- 79 people
- Sponsor
- Janssen Research & Development, LLC
Opioid-use Disorder
Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections
This is a Phase 1, 6-month, open-label, multi-center study in parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and Vivitrol…
- Trial name
- NCT04828694
- Testing
- BICX104, Vivitrol
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- BioCorRx Inc
Opioid Use Disorder
Evaluating the Efficacy of a Digital Platform to Deliver Comprehensive Treatment for Opioid Use Disorder
Buprenorphine Evaluation and Telehealth Study (BEaTS) Comparison of retention in care between telehealth-based care and treatment as usual.
- Trial name
- BEaTS (NCT05529225)
- Where
- 2 sites in United States
- Volunteers
- 159 people
- Sponsor
- Boulder Care
Analgesia
Study of Post-Herniorrhaphy Non-opioid MMA Regimens
This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal…
- Trial name
- NCT03907176
- Testing
- HTX-011, Luer lock applicator, Ibuprofen
- Where
- 30 sites in United States
- Volunteers
- 209 people
- Sponsor
- Heron Therapeutics
Opioid Use Disorder
Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder
This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for…
- Trial name
- NCT02559973
- Testing
- RBP-6000, SUBOXONE Sublingual Film
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Indivior Inc.
Usage of Prescription Opioids
Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction
This is a clinical study on patients who have been prescribed opioids (narcotic pain relievers) for the treatment of pain, to determine what genetic factors influence outcome of treatment.
- Trial name
- NCT01562353
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Analgesic Solutions
Opioid Use Disorder
Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder
This is a multiple-dose study in non-treatment seeking male and female subjects with moderate to severe opioid use disorder who meet criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) to…
- Trial name
- NCT02044094
- Testing
- Buprenorphine, buprenorphine and naloxone, hydromorphone
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Indivior Inc.
Opioid-use Disorder, Opioid Dependence
Efficacy And Safety Of An Innovative Treatment Of 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…
- Conditions
- Opioid-use Disorder, Opioid Dependence, Opioid Abuse
- Trial name
- NCT04340622
- Testing
- supra-luminous LED
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- MindLight, LLC
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
Opioid Use Disorder
SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
There is an urgent unmet medical need for a cost-effective, environmentally friendly, in-home opioid disposal solution for surgical patients that is clinically proven to reduce opioid use disorder that is substantiated with…
- Trial name
- Drug Disposal (NCT06215170)
- Testing
- SafeMedWaste
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- SafeMedWaste, Inc.
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 Use Disorder
Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms
The purpose of this prospective study is to investigate the efficacy of the Bridge™ device in reducing the symptoms of opioid withdrawal in a blind comparison to a sham device.
- Trial name
- NCT05924945
- Testing
- Bridge™ active device
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Masimo Corporation
Opioid-use Disorder
mHealth for Patient Self-Management of Opioid Use Disorder
Twenty individuals diagnosed with opioid use disorder (OUD) will be recruited to participate in a beta test to demonstrate feasibility of using an online tool to help them better self-manage their recovery.
- Trial name
- NCT03633929
- Testing
- KIOS OUD
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Biomedical Development Corporation
Opioid-Induced Constipation
Safety and Preliminary Efficacy of BGP345A in Constipation Due to Opioid-based Medications
The purpose of this study is to assess safety and preliminary efficacy of BGP345A in patients with constipation due to the use of opioid-based medications for the management of chronic non cancer pain.
- Trial name
- OIC1 (NCT05133076)
- Testing
- Lactobacillus gasseri BGP345A
- Where
- 4 sites in France
- Volunteers
- 14 people
- Sponsor
- BioGaia Pharma AB
Addiction
A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers
The primary objective of this study is to assess the safety and tolerability of a single day dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the study having a different set of healthy…
- Trial name
- NCT04292197
- Testing
- 18-MC Compound
- Where
- Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Definium Therapeutics US, 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