Clinical trials: Opioid-related Disorders
Opioid Induced Bowel Dysfunction
Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.
- Trial name
- NCT01122030
- Testing
- Naldemedine
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Shionogi
Opioid-Induced Bowel Dysfunction
Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.
- Trial name
- NCT00620061
- Testing
- Lubiprostone 24
- Where
- 123 sites in United States, Canada
- Volunteers
- 439 people
- Sponsor
- Sucampo Pharma Americas, LLC
Opioid Dependence
A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
- Trial name
- NCT01453374
- Testing
- VIVITROL 380mg
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Alkermes, Inc.
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
SUBLOCADE Long-term Outcomes
This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the…
- Trial name
- NCT05860959
- Where
- 49 sites in United States, Australia and 2 more
- Volunteers
- 480 people
- Sponsor
- Indivior Inc.
Narcotic Abuse, Opioid-related Disorders
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male…
- Conditions
- Narcotic Abuse, Opioid-related Disorders, Analgesia, Chronic Pain
- Trial name
- NCT01595867
- Testing
- EMBEDA - morphine sulfate/ naltrexone hydrochloride, morphine sulfate CR crushed.
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Pain, Pain
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
This Phase 2 study will evaluate whether multiple doses of cebranopadol suppress opioid withdrawal signs and symptoms compared with placebo in adults with chronic pain who are physically dependent on prescribed opioids.
- Conditions
- Chronic Pain, Pain, Opioid Withdrawal (Disorder), Opioid Use Disorder
- Trial name
- NCT07874620
- Testing
- Cebranopadol
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- Adneuris Therapeutics, Inc.
Opioid Dependency
A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs.
- Trial name
- NCT01114308
- Testing
- Probuphine (buprenorphine implant), Buprenorphine
- Where
- 20 sites in United States
- Volunteers
- 287 people
- Sponsor
- Titan Pharmaceuticals
Opioid Related Disorder
Transfer of Subjects From Subutex/Suboxone to RBP-6300
This study is designed to determine if opioid dependent subjects who are already receiving Subutex and/or Suboxone can transfer to RBP-6300.
- Trial name
- NCT01582347
- Testing
- RBP-6300, Subutex®/Suboxone®
- Where
- 15 sites in Austria, Czechia and 2 more
- Volunteers
- 143 people
- Sponsor
- Indivior Inc.
Pain
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
The purpose of the study is to evaluate the efficacy and safety of OraVescent fentanyl treatment compared to placebo treatment monthly over a 12-week treatment period in alleviating breakthrough pain (BTP) in opioid-tolerant…
- Trial name
- NCT00343733
- Testing
- OraVescent Fentanyl
- Where
- 21 sites in United States
- Volunteers
- 120 people
- Sponsor
- Cephalon
Opioid Related Disorders, Opiate Addiction
Evaluation of Changes in Prescribing Behavior of ER/LA Opioid Prescribers
A study will be performed to evaluate changes in prescribing behavior of prescribers of ER/LA opioids
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02920762
- Testing
- on-interventional study - retrospective database review
- Volunteers
- 5,575,834 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid-Related Disorders, Opiate Addiction
A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain
The purpose of this study is to quantify the serious risks of prescription opioid misuse or abuse or opioid use disorder (OUD) associated with the long term use of opioid analgesics for management of chronic pain, among patients…
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02751762
- Testing
- Observation Only
- Where
- 2 sites in United States
- Volunteers
- 3,600 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
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-Induced Constipation (OIC)
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
- Trial name
- NCT01336205
- Testing
- NKTR-118, Usual care
- Where
- 169 sites in United States
- Volunteers
- 844 people
- Sponsor
- AstraZeneca
Opioid Addiction
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
The purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction.
- Trial name
- NCT02282072
- Testing
- Deep brain stimulation：PINS Stimulation System
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Opioid-Related Disorders
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.
- Trial name
- NCT00992095
- Testing
- buprenorphine hydrochloride
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
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-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.
Alcohol Dependence
A Study of Brain Receptor Occupancy in Healthy Subjects
To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.
- Trial name
- NCT01232439
- Testing
- opioid receptor kappa antagonist
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Opioid-related Disorders
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active…
- Trial name
- NCT00637000
- Testing
- Buprenorphine soluble film, Buprenorphine/naloxone film strip
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Indivior Inc.