Clinical trials: Opioid Use Disorder
Opioid Use Disorder
Single-dose, Study of RBP-6000 in Opioid Dependent Individuals
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an injection of RBP-6000.
- Trial name
- NCT02765867
- Testing
- RBP-6000
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone.
- Trial name
- NCT05062577
- Testing
- ASP8062, buprenorphine/naloxone
- Sponsor
- Astellas Pharma Global Development, Inc.
Opioid Use Disorder
Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT
The goal of this clinical trial is to examine the usefulness of a virtual reality-delivered intervention for individuals with opioid use disorder who are taking medication.
- Trial name
- NCT06021431
- Testing
- MORE-VR, Treatment as Usual
- Where
- 2 sites in United States
- Volunteers
- 128 people
- Sponsor
- BehaVR LLC
Opioid Use Disorder
Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons
This study will examine the safety and efficacy of the O'Neil Long Acting Naltrexone Implant (OLANI) in persons with opioid dependency who are seeking relapse-prevention treatment.
- Trial name
- GM0020 (NCT05382091)
- Testing
- naltrexone implant
- Volunteers
- 250 people
- Sponsor
- Go Medical Industries Pty Ltd
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
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants
The primary purpose of this study was to assess the safety and tolerability of multiple doses of ASP8062 or placebo alone and in combination with a single dose of morphine.
- Trial name
- NCT04448561
- Testing
- ASP8082, morphine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Opioid Related Disorders, Opiate Addiction
Evaluation of Drug Utilization Patterns for Extended Release/Long Acting Opioids and Comparator Products
A drug utilization study will be performed to describe trends in the number of prescriptions and patients for class REMS ER/LA opioids and comparator products.
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02925806
- Testing
- Non-interventional study - retrospective database review
- Volunteers
- 5,575,834 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid-use Disorder
Evaluation of Long-term Buprenorphine Plasma Exposure
The study objective is to characterise the long-term plasma exposure to buprenorphine after stopping SUBLOCADE treatment. There are no interventions planned.
- Trial name
- NCT03752528
- Testing
- Blood sample collection, Urine sample collection
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- Indivior Inc.
Opiate Dependency Relapse
Using mHealth to Aid Opioid Addicts
The purpose of the proposed study is perform focus groups to identify and prioritize features of the SubAID application (APP). The SubAID APP is smartphone APP being created to support patients self-managing…
- Trial name
- NCT01955902
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Care Team Solutions
Moderate to Severe Opioid-use Disorder
Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in High-risk Users
The primary objective of the induction phase of the study is to compare treatment retention of participants following rapid induction or standard of care (SoC) induction onto extended-release buprenorphine.
- Trial name
- NCT04995029
- Testing
- Transmucosal Buprenorphine, Extended-release Buprenorphine
- Where
- 29 sites in United States, Canada
- Volunteers
- 785 people
- Sponsor
- Indivior Inc.
Opioid Dependence, Opioid Use
Impact of a Behavioral Tele-health Program on the Quality of Recovery for Patients Undergoing Total Joint Replacement Surgery
The quality of recovery after surgery is multi-factorial and includes both physical and mental factors. Persistent pain after surgery is a common problem after major surgery and can result in persistent opioid use.
- Conditions
- Opioid Dependence, Opioid Use, Pain, Joint
- Trial name
- NCT05367050
- Testing
- Lucid Lane Therapy Program, Surgical Preparedness Course
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Lucid Lane, 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.
Opioid-use Disorder
CBT4CBT for Office Based Buprenorphine
In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a…
- Trial name
- NCT03580902
- Testing
- CBT4CBT-Buprenorphine, Buprenorphine/naloxone
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- CBT4CBT, LLC
Opioid Use Disorder
A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, 2 fixed sequences, multiple dose study in healthy male and/or female recreational opioid users.
- Trial name
- NCT05587998
- Testing
- Morphine, AZD4041
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Opioid Use Disorder
PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study
The goal of this clinical trial is to learn if it is feasible to use PEX010 for the treatment of opioid use disorder in adults. The study will also assess the safety of PEX010.
- Trial name
- NCT06608459
- Testing
- PEX010-Assisted Therapy
- Volunteers
- 10 people
- Sponsor
- Filament Health Corp.
Opioid-use Disorder, Opioid Withdrawal
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
- Trial name
- RESTORE (NCT05053503)
- Testing
- Sparrow Ascent Therapy System, Lofexidine, Extended-release injectable naltrexone
- Where
- 4 sites in United States
- Volunteers
- 108 people
- Sponsor
- Spark Biomedical, Inc.
Opioid-use Disorder
Technology for MAT in Primary Care - Phase 1
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
- NCT05006846
- Testing
- Opioid Addiction Recovery Support Software Platform
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Q2i, LLC
Healthy Volunteer, Opioid-use Disorder
Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder
The primary objectives for the study are: Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in healthy volunteers.
- Trial name
- NCT04976855
- Testing
- INDV-2000, SUBOXONE® sublingual film
- Where
- 3 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
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.
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