Clinical trials: Opiate-Related Disorders
Opiate Dependence
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX…
- Trial name
- NCT01180647
- Testing
- Extended-Release Naltrexone, Motivational Enhancement Counseling
- Where
- 2 sites in United States
- Volunteers
- 48 people
- Sponsor
- NYU Langone Health
Computer + Fluency, Computer Only
Evaluation of a Computerized Opioid Overdose Prevention Program
Unintentional fatal drug overdose (OD) is now the 2nd leading cause of accidental death in the general population. Fatal OD from opioid analgesics specifically has increased over 400% between 1999 and 2008, and nonfatal overdose…
- Conditions
- Computer + Fluency, Computer Only, Treatment as Usual
- Trial name
- NCT02040077
- Testing
- Computer + Fluency, Computer Only, Treatment as Usual
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Johns Hopkins University
Opiate Antagonist Overdose, Opioid-Related Disorders
Naloxone Auto-injector as a Universal Precaution for Patients With Opioid Use Disorder
The purpose of this pilot-study is to to distribute naloxone auto-injector in a "Universal Precaution" manner to patients with opioid substance use disorder.
- Trial name
- NCT02669901
- Testing
- Naloxone Auto-Injector
- Where
- United States
- Volunteers
- 395 people, healthy volunteers welcome
- Sponsor
- University of New Mexico
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.
Neonatal Abstinence Syndrome, Neonatal Opiate Withdrawal Syndrome
Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure
Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine.
- Trial name
- B-PHORE (NCT03608696)
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Thomas Jefferson University
Acute Pain, Wound Care
RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain
The Ketamine for Acute Pain in Burns study is a randomized, double-blind, parallel group trial (RCT) with active control (usual care) contrasting the efficacy and safety of "Ketamine Plus Opiate-based usual care" (O+K) with the…
- Conditions
- Acute Pain, Wound Care, Posttraumatic Stress Disorder
- Trial name
- NCT03305055
- Testing
- ketamine, Fentanyl
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Johns Hopkins University
Opiate Dependence, Cocaine Dependence
Imaging Synaptic Density in Cocaine and Opiate Addiction In Vivo Using 11UCB-J PET
This study aims to measure synaptic density in the brains (including in ventral striatum [VS] and medial prefrontal cortex [mPFC]) of abstinent subjects with Cocaine Use Disorder (CUD) or Opiate Use Disorder (OUD) as compared to…
- Trial name
- NCT03527485
- Testing
- 11UCB-J PET Scan
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Yale University
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
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
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
Neonatal Abstinence Syndrome
Morphine Versus Methadone for Opiate Exposed Infants With Neonatal Abstinence Syndrome
This study investigates the use of methadone versus morphine wean for the treatment of neonatal abstinence syndrome for infants exposed to opioids in utero.
- Trial name
- NCT02851303
- Testing
- Morphine, Methadone
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of New Mexico
Bipolar Disorder, Schizoaffective Disorder
Effects of Pentazocine Versus Lorazepam on Manic Symptoms
Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals. To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind study.
- Conditions
- Bipolar Disorder, Schizoaffective Disorder, Manic Disorder, Mania
- Trial name
- NCT00431184
- Testing
- Pentazocine, Lorazepam
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Mclean Hospital
Opioid Overdose
Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal
The goal of the proposed, proof-of-concept study is to test the combined effects of vaporized marijuana [Delta-9-tetrahydracannabinol (THC)] with NLX as a proof of concept towards the possible development of a combined overdose…
- Trial name
- NCT05114460
- Testing
- Naloxone, Marijuana
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- New York State Psychiatric Institute
Opioid-use Disorder
An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder
The proposed study is a 12-week, open-label pilot study of sublocade (extended-release burprenorphine, BXR) as treatment for opiate use disorder (OUD) testing positive for Highly Potent Synthetic Opioids (HPSO).
- Trial name
- NCT03861338
- Testing
- Sublocade
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- New York State Psychiatric Institute
Opioid-Related Disorders, NAS
MOms in REcovery (MORE) Study: Defining Optimal Care
Northern New England has among the highest rates of opioid dependence in the U.S. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant women with…
- Conditions
- Opioid-Related Disorders, NAS, Substance Use Disorders, Mental Health
- Trial name
- MORE (NCT04251208)
- Testing
- Observational Study
- Where
- 10 sites in United States
- Volunteers
- 2,510 people
- Sponsor
- Trustees of Dartmouth College
Neonatal Abstinence Syndrome
Donor Human Milk in Neonatal Abstinence Syndrome
This study is designed to develop pilot data on the acceptability and benefit of donor human milk for infants undergoing pharmacologic treatment for NAS.
- Trial name
- DHM&NAS (NCT02182973)
- Testing
- donor human milk
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neolac Inc dba Medolac Laboratories
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.