Clinical trials: Opioid-related Disorders
Opioid Overdose
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into…
- Trial name
- NCT06719986
- Testing
- Nalmefene HCl injection, Naloxone HCl intranasal
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Opioid Use Disorder
Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder
This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for…
- Trial name
- NCT02559973
- Testing
- RBP-6000, SUBOXONE Sublingual Film
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Indivior Inc.
Opioid-Related Disorders, Opiate Addiction
Cross-Sectional Study to Define and Validate "Doctor/Pharmacy Shopping" as Outcomes Suggestive of Abuse and/or Addiction
The purpose of this study is to formulate definitions of doctor/pharmacy shopping and evaluate its association with abuse/addiction
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02668549
- Testing
- DB review for Doctor/Pharmacy Shopping Behavior
- Volunteers
- 164,923 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Constipation
Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation
The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in adult Asian subjects with opioid-induced constipation associated with…
- Trial name
- NCT00936884
- Testing
- Methylnaltrexone
- Where
- 6 sites in South Korea, Taiwan
- Volunteers
- 50 people
- Sponsor
- Bausch Health Americas, Inc.
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 (OBD) Pivotal Assessment of Lubiprostone (OPAL)
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
- Trial name
- NCT01298219
- Testing
- Lubiprostone
- Where
- 142 sites in United States, Belgium and 5 more
- Volunteers
- 439 people
- Sponsor
- Sucampo Pharma Americas, LLC
Healthy
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.
- Trial name
- NCT01746901
- Testing
- intact ALO-02 60 mg/7.2 mg, crushed ALO-02 60 mg/7.2 mg, crushed oxycodone IR 60 mg
- Where
- Canada
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Pfizer
Opioid Use Disorder
A Stepped-Wedge Cluster Randomized Trial of a Digital App to Support Medication-Assisted Treatment in Individuals With Opioid Use Disorder
The goal of this clinical trial is to learn if a mobile health app called Recovery Connect can help people stay in treatment for opioid use disorder.
- Trial name
- SMART-OUD (NCT07140926)
- Testing
- Recovery Connect
- Where
- 9 sites in United States
- Volunteers
- 1,524 people
- Sponsor
- Bright Therapeutics
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.
Substance Abuse
A Comparison of How Likely it is That Different Tablets of Oxycodone Will be Broken up and Snorted by Adults Who Sometimes Take Drugs for Pleasure
The trial comprises an Enrollment Visit, a Qualification Phase, a Treatment Phase (including 3 treatment periods), a Final Examination, and a Follow-up Phone Call.
- Trial name
- NCT03765346
- Testing
- Oxycodone IR ADF, Oxycodone API powder
- Where
- Canada
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Opioid Dependence
Probuphine Innovations for Clinical Effectiveness (PRINCE)
HITLAB will conduct a crossover study wherein participants will be asked to wear an actigraphy device continuously for 12 weeks.
- Trial name
- PRINCE (NCT02896660)
- Testing
- ActiGraph Link
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Healthcare Innovation Technology Lab
Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
A Brief Negotiation Interview Chatbot to Improve Buprenorphine Engagement Among Justice-Involved Individuals
Primary Objective: Conduct pilot study to assess effects of brief negotiation interview (BNI) Chatbot among individuals involved in the Connecticut criminal justice system with opioid use disorder (OUD).
- Conditions
- Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe, Criminal Behavior
- Trial name
- BNICHAT (NCT04982627)
- Testing
- BNI Chatbot, OUD Education & Treatment Resources
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Center for Progressive Recovery, LLC
Opioid Withdrawal
Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance.
- Trial name
- NCT04470050
- Testing
- Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 225 people
- Sponsor
- BioXcel Therapeutics Inc
Opioid-induced Constipation
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.
- Trial name
- NCT01993940
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 553 people
- Sponsor
- Shionogi
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.
Opioid Use Disorder
Brain Training for Substance Use Disorders
Participants play games designed to train visual attention towards natural, non-drug-related scenarios. A biofeedback loop between gameplay and an electroencephalogram (EEG) system monitors game performance and guides game…
- Trial name
- NCT06870110
- Testing
- Bias Modification Biofeedback
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Neurotype Inc.
Opioid Overdose
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
- Trial name
- NCT05377255
- Testing
- 16 mg naloxone AP003, 8 mg naloxone NARCAN Nasal Spray
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Opioid Dependence, Opioid Related Disorders
A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse
This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male and female subjects with an American Psychiatric Association Diagnostic and Statistical Manual DSM-IV-TR diagnosis of cocaine abuse.
- Conditions
- Opioid Dependence, Opioid Related Disorders, Cocaine Dependence
- Trial name
- RBP-8000 (NCT01846481)
- Testing
- RBP-8000 100 mg, Cocaine, RBP-8000 200 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Opioid-use Disorder
OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC)…
- Trial name
- NCT04948307
- Testing
- OXD01 digital therapy, Standard of Care
- Where
- 21 sites in United States
- Volunteers
- 437 people
- Sponsor
- Orexo AB
Opioid-use Disorder
Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections
This is a Phase 1, 6-month, open-label, multi-center study in parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and Vivitrol…
- Trial name
- NCT04828694
- Testing
- BICX104, Vivitrol
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- BioCorRx Inc