Clinical trials: Substance-Related Disorder
Opioid Use Disorder
Remotely Observed Methadone Evaluation II
Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs).
- Trial name
- ROME II (NCT06338280)
- Testing
- Sonara
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Sonara Health
Substance Use Disorders, Substance-Related Disorders
Socializing a Science-Based Digital Therapeutic for Substance Use Disorders
The purpose of this study is to evaluate the effectiveness of an intervention delivered on a smartphone. This study examines whether this intervention might improve treatment outcomes for people with substance use disorders.
- Trial name
- NCT05648786
- Testing
- Laddr® plus Behavioral- Group and individual counseling, Behavioral- Group and individual counseling
- Where
- United States
- Volunteers
- 189 people
- Sponsor
- Square2 Systems, Inc.
Alcohol Use Disorder
Study of Sunobinop on Craving in Alcohol Use Disorder
The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol craving in subjects with moderate to severe alcohol use disorder and these subjects are seeking treatment.
- Trial name
- NCT06545929
- Testing
- Sunobinop
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Knoa Pharma LLC
HIV Infections, HIV Seronegativity
Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand
The purpose of this study is to determine if the vaccine, AIDSVAX B/E, will protect intravenous drug users from becoming infected with HIV.
- Trial name
- NCT00006327
- Testing
- MN rgp120/HIV-1 and A244 rgp120/HIV-1
- Where
- Thailand
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- VaxGen
Opioid Induced Constipation
Naloxegol US PMR CV Safety.
The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of cancer and who are treated with opioids chronically
- Trial name
- NCT02813356
- Testing
- naloxegol, non-PAMORA
- Where
- 2 sites in United States
- Volunteers
- 8,800 people
- Sponsor
- Valinor Pharma LLC
Opioid Use Disorder
Reward-based Technology to Improve OUD Treatment
Millions of people in the US misuse opioids each year. Medication assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of OUD persons access MAT, and treatment non-adherence is common…
- Trial name
- OARSCM (NCT05180669)
- Testing
- OARSCM Software Application, MyMAT Software Application
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Q2i, LLC
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.
Motivational Interviewing, Alcohol Use Disorder
ClientBot: a Conversational Agent That Supports Skills Practice and Feedback for Motivational Interviewing
This multi-stage study includes qualitative interviews, usability research, and a randomized training study of technology implementation in a real-world clinical setting.
- Trial name
- NCT05479890
- Testing
- ClientBot
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Lyssn.io, Inc.
Smoking Cessation, Nicotine Dependence
Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO)
PRECESTO is a randomized, double-blind, cross-over trial on 34 smokers who do not want to stop smoking and get high satisfaction from smoking.
- Trial name
- PRECESTO (NCT06091826)
- Testing
- NFL-101
- Where
- France
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- NFL Biosciences SAS
Opioid-Induced Constipation
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids.
- Trial name
- NCT00858754
- Testing
- methylnaltrexone
- Where
- 8 sites in United States, Canada and 2 more
- Sponsor
- Bausch Health Americas, Inc.
Opioid-Induced Constipation (OIC)
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative…
- Trial name
- NCT01309841
- Testing
- NKTR-118
- Where
- 117 sites in United States, Australia and 2 more
- Volunteers
- 652 people
- Sponsor
- AstraZeneca
Alcohol Hepatitis
A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)
A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)
- Trial name
- NCT06685692
- Testing
- ADX-629
- Where
- 6 sites in United States
- Volunteers
- 4 people
- Sponsor
- Aldeyra Therapeutics, Inc.
Opioid Use Disorder
Reward-Based Recovery Outcomes Management for Opioid Use Disorder
A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in…
- Trial name
- NCT04669249
- Testing
- PROCare
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medical Decision Logic, Inc.
Substance Use Disorders
Contingency Management Using Smartphone App in Patients With SUD
The purpose of this research study is to test the acceptance and efficacy of a smartphone app (DynamiCare Rewards) for patients with substance use disorder (SUD) who are in active treatment and recovery at BrightView.
- Trial name
- NCT04162132
- Testing
- Smartphone app
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- BrightView LLC
Constipation
TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects
The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated by the body and to evaluate whether it is safe and well tolerated.
- Trial name
- NCT01655771
- Testing
- TD-1211 Dose 1, TD-1211 Dose 2
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Glycyx Therapeutics
Alcohol Dependence
ALK29-002: A Study of Baclofen Formulations in Healthy Adults
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
- Trial name
- NCT00802035
- Testing
- Baclofen IR, Baclofen ER
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Alcoholic Liver Cirrhosis
Study to Evaluate Hepatic Artery Injection of Autologous Human Bone Marrow-Derived MSCs in Patients With Alcoholic LC
This study is to evaluate the safety and efficacy of a single dose of Cellgram™ delivered via hepatic artery in patients with decompensated alcoholic liver cirrhosis.
- Trial name
- NCT03838250
- Testing
- Cellgram™ (Bone marrow-derived MSCs)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Pharmicell Co., Ltd.
Opioid Use Disorder
SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion
There is an urgent unmet medical need for a cost-effective, environmentally friendly, in-home opioid disposal solution for surgical patients that is clinically proven to reduce opioid use disorder that is substantiated with…
- Trial name
- Drug Disposal (NCT06215170)
- Testing
- SafeMedWaste
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- SafeMedWaste, Inc.
Substance-Related Disorders
Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment
The purpose of this study is to provide a comprehensive evaluation of the new, Navigating my Journey program for adolescents receiving treatment in an outpatient substance abuse center.
- Trial name
- NCT02125539
- Testing
- Navigating my Journey program, Attention Control
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Inflexxion, Inc.
Opioid Dependence
Extension to Safety and Efficacy of Probuphine in the Treatment of 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-807 (NCT00630201)
- Testing
- Probuphine (buprenorphine implant)
- Where
- 15 sites in United States
- Volunteers
- 62 people
- Sponsor
- Titan Pharmaceuticals