Clinical trials: Substance-Related Disorder
Opioid Dependency
Study of Probuphine in Patients With Opioid Dependence
Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low.
- Trial name
- PRO-809 (NCT00772785)
- Testing
- Probuphine (buprenorphine implant)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Titan Pharmaceuticals
Alcohol Abuse
Adaptive Goal-Directed Adherence Tracking and Enhancement
Talaria, Inc., has designed an adherence tracking and enhancement system, called AGATE, which uses the text messaging and internet capabilities of modern cellular phones to address the problem of medication adherence in clinical…
- Trial name
- AGATE (NCT01349985)
- Testing
- AGATE, SASED
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Talaria, Inc
Tobacco Dependence
Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.
- Trial name
- NCT01084707
- Testing
- Oral Nicotine, Nicotine Lozenge, Nicotine gum
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- McNeil AB
Opioid Dependence, Methadone Withdrawal Syndrome
Pilot Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients
The primary objective of this study is to assess QTc (an interval of the heart rhythm) interaction effects between lofexidine and methadone.
- Trial name
- NCT01558934
- Testing
- Lofexidine HCl
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Coronary Artery Disease, Congestive Heart Failure
Prognostic Indicators as Provided by the EPIC ClearView
The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known…
- Conditions
- Coronary Artery Disease, Congestive Heart Failure, Valvular Heart Disease, Atrial Fibrillation
- Trial name
- GBMC (NCT01476995)
- Where
- United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Epic Research & Diagnostics, Inc.
Opioid Use Disorder
Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL
This study will evaluate the efficacy, safety, and tolerability of oral naltrexone used in conjunction with buprenorphine in adults with Opioid Use Disorder transitioning from buprenorphine maintenance prior to the first dose of…
- Trial name
- NCT02696434
- Testing
- Naltrexone, Buprenorphine
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Alkermes, Inc.
Acute Liver Failure
Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion
VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of…
- Trial name
- NCT01452295
- Testing
- ELAD (Extracorporeal Liver Assist System)
- Sponsor
- Vital Therapies, Inc.
Addiction, Opioid Dependence
Exploratory Dose Ranging Study Assessing APH-1501 for the Treatment of Opioid Addiction
The purpose of this study is determine the safety, efficacy and tolerability of a novel drug APH-1501 as a pharmacotherapy for Opioid Dependence. The investigators will evaluate the safety of escalating doses APH-1501.
- Conditions
- Addiction, Opioid Dependence, Opioid Withdrawal
- Trial name
- NCT03813095
- Testing
- APH-1501
- Volunteers
- 32 people
- Sponsor
- Aphios
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
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Depressive Disorder, Anxiety Disorders
AI to Support Mental Health Case Management Providers
The goal of this clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder.
- Conditions
- Depressive Disorder, Anxiety Disorders, Substance Use Disorders, Post Traumatic Stress Disorder
- Trial name
- NCT06280170
- Testing
- Artificial Intelligence platform for case managers
- Where
- United States
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Eleos Health
Anxiety, Depressive Symptoms
Efficacy of Digital Problem Solving Application in Reduction of Anxiety, Depression and Substance Use Disorder Symptoms
The focus of this study is the impact of usage of a mobile application to support problem-solving therapy on symptoms of anxiety, depression and substance use.
- Conditions
- Anxiety, Depressive Symptoms, Substance Use Disorders
- Trial name
- Efficacy (NCT06346431)
- Testing
- DSPT - Digital Support for Problem-solving Therapy
- Volunteers
- 100 people
- Sponsor
- 7 Generation Games
Cocaine Abuse
ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine
The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when administered to opioid-experienced cocaine abusers.
- Trial name
- NCT01366001
- Testing
- ALKS 33-BUP, ALKS 33
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Alkermes, Inc.
Opioid Dependence, on Agonist Therapy
Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent…
- Trial name
- NCT01903005
- Testing
- Higher bioavailability BNX sublingual tablets
- Where
- 28 sites in United States
- Volunteers
- 668 people
- Sponsor
- Orexo AB
Tobacco Use Disorder
A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers
The purpose of this study is to assess the bioequivalence of the 21mg nicotine transdermal patch from GSK Dungarvan (Test) compared to the 21mg nicotine transdermal patch currently manufactured by Alza (Reference).
- Trial name
- NCT05024747
- Testing
- NicoDerm CQ patch (GSK Dungarvan), NicoDerm CQ (Alza)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- HALEON
Analgesia, Acute Pain
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed…
- Conditions
- Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse
- Trial name
- NCT01530542
- Testing
- oxycodone hydrochloride, marketed oxycodone hydrochloride
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Pfizer
Alcoholic Hepatitis, Acute Alcoholic Hepatitis
MRG-001 in Patients With Alcoholic Hepatitis
The goal of this study is to test MRG-001 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of MRG-001 in patients with severe alcoholic hepatitis…
- Trial name
- NCT06307522
- Testing
- MRG-001
- Volunteers
- 32 people
- Sponsor
- MedRegen LLC
Alcohol Dependence
Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients
The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy…
- Trial name
- ALPADIR (NCT01738282)
- Testing
- Baclofen
- Where
- 38 sites in France
- Volunteers
- 316 people
- Sponsor
- Ethypharm
Opioid-Related Disorders, Opiate Addiction
A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire
The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- POMAQ (NCT02678507)
- Testing
- Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- Volunteers
- 800 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Alcohol Associated Hepatitis
FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).
- Trial name
- FRESH (NCT05639543)
- Testing
- INT-787
- Where
- 29 sites in United States, France and 1 more
- Volunteers
- 67 people
- Sponsor
- Intercept Pharmaceuticals