Clinical trials: Opioid-Related Disorders
Opioid-use Disorder, Opioid-Related Disorders
Substance Use Treatment and Recovery Team (START)
Despite high prevalence, few hospitalized inpatients with opioid or alcohol use disorders (OAUDs) receive evidence-based treatments while in the hospital or get linked with appropriate follow-up care, leading to poor clinical…
- Conditions
- Opioid-use Disorder, Opioid-Related Disorders, Alcohol Use Disorder, Alcohol-Related Disorders
- Trial name
- START (NCT04314648)
- Testing
- Substance Use Treatment and Recovery Team (START)
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- RAND
Opioid-use Disorder
PRimary Care Opioid Use Disorders Treatment (PROUD) Trial
Effective treatment for opioid use disorders (OUDs) requires medications. Two medications for treating OUDs-buprenorphine and injectable naltrexone-can be prescribed in primary care (PC).
- Trial name
- PROUD (NCT03407638)
- Testing
- PROUD Intervention
- Where
- 6 sites in United States
- Volunteers
- 377,373 people
- Sponsor
- Kaiser Permanente
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, Opioid Dependence
Remote Observed Dosing of Suboxone to Improve Clinical Practice
This is a 15-week, outpatient study of remote observed dosing to improve suboxone compliance in opiate dependent subjects.The main purpose of this study is to see if watching patients take their medication will improve treatment…
- Conditions
- Opioid-use Disorder, Opioid Dependence, Opiate Dependence
- Trial name
- NCT03769025
- Testing
- Suboxone Remote Observed Dosing, Suboxone Attention Control
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- University of Pennsylvania
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
Opioid Dependence, Opioid Withdrawal
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
This study involves inducting treatment seeking opioid dependent participants onto buprenorphine. Once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease…
- Conditions
- Opioid Dependence, Opioid Withdrawal, Opioid Detoxification
- Trial name
- Detox (NCT01262092)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Arkansas
Substance-Related Disorders
Encouraging Judicious Prescribing of Opioids in Los Angeles County
In collaboration with the Los Angeles County Medical Examiner's Office and the State of California's controlled Substance Utilization Review and Evaluation System (CURES), the investigators propose to review opioid poisonings…
- Trial name
- NCT03856593
- Testing
- Standard letter, Comparator letter
- Where
- United States
- Volunteers
- 541 people
- Sponsor
- University of Southern California
Substance Use Disorders, Opioid-use Disorder
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
Investigators will test a novel protocol for starting BUP (buprenorphine-naloxone) treatment. The BUP microdose induction protocol has participants start very low doses of BUP without stopping other opioids that they are taking.
- Conditions
- Substance Use Disorders, Opioid-use Disorder, Chronic Pain
- Trial name
- Micro-bupe (NCT05118204)
- Testing
- BUP microdose induction, TAU, Linkage to outpatient BUP treatment
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Montefiore Medical Center
Opioid-Induced Constipation
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to…
- Trial name
- NCT01384292
- Testing
- NKTR-118
- Where
- 140 sites in United States, Australia and 12 more
- Volunteers
- 14 people
- Sponsor
- AstraZeneca
Opioid Use Disorder
Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults
The purpose of this study is to evaluate the safety and blood levels of a medicine, naltrexone, contained within an implant in healthy volunteers age 18 to 65 years.
- Trial name
- NCT06216132
- Testing
- BIOPIN-6 Active Implant with Naltrexone
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Akyso Therapeutics, LLC
Opioid-Induced Bowel Dysfunction
Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).
- Trial name
- OPAL (NCT00597428)
- Testing
- Lubiprostone
- Where
- 114 sites in United States, Canada
- Volunteers
- 437 people
- Sponsor
- Sucampo Pharma Americas, LLC
Opioid-Related Disorders, Opioid Dependence
An Innovative Intervention for OUD Treatment
The Bridge Device (BD) is a neuromodulator medical device that has been cleared by the FDA for Opioid Use Disorder (OUD) treatment.
- Conditions
- Opioid-Related Disorders, Opioid Dependence, Opioid Addiction, Opioid Withdrawal
- Trial name
- Bridge (NCT04325659)
- Testing
- Bridge Device, Lofexidine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Opioid-use Disorder
A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders
This study is an open--label randomized outpatient trial to evaluate feasibility and efficacy of rapid buprenorphine (BUP) discontinuation followed by brief course of treatment with long--acting naltrexone (XR--NTX) and to…
- Trial name
- NCT03232346
- Testing
- Vivitrol, Buprenorphine
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Opioid Dependence, Heroin Dependence
Memantine as a Supplement to Naltrexone in Treating Heroin Dependence
Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase.
- Trial name
- NAMHS (NCT00476242)
- Testing
- Vivitrol, memantine
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- New York State Psychiatric Institute
Neonatal Abstinence Syndrome
Clonidine to Treat Iatrogenic-induced Opioid Dependence in Infants
Thousands of critically ill infants (and children) are exposed to opioids and benzodiazepines to achieve sedation and analgesia as part of routine care in neonatal and pediatric intensive care units.
- Trial name
- NCT01360450
- Testing
- Clonidine HCL, saline
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Johns Hopkins University
Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome
HIV, Buprenorphine, and the Criminal Justice System
The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design.
- Conditions
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence
- Trial name
- STRIDE (NCT01550341)
- Testing
- Buprenorphine/naloxone
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Opioid-use Disorder
Initiating Substance Use Disorder Treatment for Hospitalized Opioid Use Disorder Patients.
The purpose of this 24-week study is to evaluate the impact of recovery coach intervention on rates of treatment retention, illicit opioid use, and readmission among hospitalized patients newly initiated on buprenorphine or…
- Trial name
- ISTOP (NCT03212794)
- Testing
- Recovery coach
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Opioid-Induced Hyperalgesia
Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?
Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered…
- Trial name
- NCT01210079
- Testing
- Gabapentin;
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of California, Los Angeles
Opioid-Induced Constipation
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in…
- Trial name
- NCT01186770
- Testing
- Methylnaltrexone
- Where
- 2 sites in United States
- Volunteers
- 804 people
- Sponsor
- Bausch Health Americas, Inc.
Substance Use Disorders, Infection, Soft Tissue
Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use
Standard of care for patients with opioid use disorder and complicated infections is discharge to subacute nursing facilities on IV antibiotics until completion of treatment course.
- Conditions
- Substance Use Disorders, Infection, Soft Tissue, Bacteremia, Osteomyelitis Acute
- Trial name
- AIM-STOP (NCT05521880)
- Testing
- Oritavancin
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Maryland, Baltimore