Clinical trials: Opioid Dependence
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.
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
- Trial name
- NCT00605033
- Testing
- Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484, Subutex, Buprenorphine Hydrochloride, SCH 28444
- Volunteers
- 241 people
- Sponsor
- Indivior Inc.
Opiate Dependence
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
- Trial name
- NCT00834080
- Testing
- Medisorb naltrexone 380 mg
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Alkermes, Inc.
Opioid-Related Disorders, Opiate Dependence
Acceptability and Safety of Switching From Subutex or Other Opioid Drug Dependence Therapy to Suboxone (NIS P05444)
The purpose of this study is to evaluate the acceptability and safety of switching to Suboxone® (buprenorphine plus naloxone) and the effect of the switch on medication dispensing.
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00725608
- Testing
- buprenorphine/naloxone
- Where
- Austria
- Volunteers
- 339 people
- Sponsor
- Indivior Inc.
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-Related Disorders, Opiate Dependence
Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)
The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life…
- Conditions
- Opioid-Related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00723749
- Testing
- Buprenorphine/Naloxone
- Volunteers
- 384 people
- Sponsor
- Indivior Inc.
Opiate Dependence
ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid…
- Trial name
- NCT00678418
- Testing
- VIVITROL® 380 mg
- Where
- Russia
- Volunteers
- 250 people
- Sponsor
- Alkermes, 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.
Opioid-Related Disorders, Opiate Dependence
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only.
- Trial name
- NCT01848054
- Testing
- Buprenorphine/naloxone sublingual tablets, Buprenorphine
- Where
- 14 sites in United States
- Volunteers
- 313 people
- Sponsor
- Orexo AB
Opiate-related Disorders, Opiate Dependence
Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)
This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®.
- Conditions
- Opiate-related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00684073
- Testing
- buprenorphine, buprenorphine/naloxone
- Volunteers
- 60 people
- Sponsor
- Indivior Inc.
Opioid Use Disorders
Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and…
- Trial name
- NCT02651584
- Testing
- CAM2038 SC injection, SL BPN/NX tabs
- Where
- 36 sites in United States
- Volunteers
- 428 people
- Sponsor
- Braeburn Pharmaceuticals
Opioid Dependency
Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)
This is a multi-center, open-label, preference study of two sublingual formulations of buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy.
- Trial name
- NCT01075971
- Testing
- Buprenorphine hydrochloride marketed sublingual tablet (Subutex), Buprenorphine hydrochloride fast dissolving tablet (FDT)
- Volunteers
- 52 people
- Sponsor
- Indivior Inc.
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 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 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)
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto…
- Conditions
- Opiate Dependence, Drug Dependence, Substance Dependence
- Trial name
- NCT00604188
- Testing
- Suboxone (SCH 000484), Subutex (SCH 028444)
- Volunteers
- 188 people
- Sponsor
- Merck Sharp & Dohme LLC
Opioid Related Disorder
Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects
This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of subcutaneous injections of depot buprenorphine…
- Trial name
- NCT01738503
- Testing
- RBP-6000, Subutex
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Indivior Inc.
Opioid Dependence
INDV-2000 First in Human
This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction…
- Trial name
- NCT04413552
- Testing
- INDV-2000
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Opioid Dependence
A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
The primary objective of the study is to demonstrate maintenance of treatment efficacy when transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg or less of sublingual (SL) buprenorphine…
- Trial name
- PRO-814 (NCT02180659)
- Testing
- sublingual buprenorphine tablets, Buprenorphine implant
- Volunteers
- 177 people
- Sponsor
- Titan Pharmaceuticals
Opioid Use Disorder
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
- Trial name
- NCT02537574
- Testing
- NTX/BUP, NTX/PBO-B, PBO-N/PBO-B
- Where
- 20 sites in United States
- Volunteers
- 380 people
- Sponsor
- Alkermes, Inc.