Clinical trials: Substance-Related Disorders
Opioid-Induced Constipation
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.
- Trial name
- NCT01901302
- Testing
- CB-5945
- Volunteers
- 61 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Acute Alcohol Intoxication
Assessing the Safety and Efficacy of FSD-F2R6-A-CP in Volunteers in an Induced State of Alcohol Intoxication
This will be a (2 visit) double-blind, randomized, placebo crossover design clinical study to assess the potential benefits of FSD-F2R6-A-CP versus a placebo by assessing its impact on side effect profiles as well as cognitive…
- Trial name
- METAL-2 (NCT06505239)
- Testing
- FSD-F2R6-A-CP
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Quantum Biopharma
Substance Abuse
Substance Treatment and HIV Testing and Referral System
The lack of substance screening and referral in healthcare settings is a significant problem with far-reaching consequences, including excess morbidity, premature mortality, and inflated healthcare costs.
- Trial name
- STaRS (NCT01488630)
- Testing
- STaRS
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Polaris Health Directions
Nicotine Addiction, Cigarette Smoking
Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use
Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes will be recruited and randomly assigned to one of five groups (n=64/group), who will be asked to switch for 12 weeks to ad libitum use of…
- Trial name
- DUAL (NCT02870218)
- Testing
- Smoking research cigarettes with e-cigarette, Nicotine discrimination thresholds
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Rose Research Center, LLC
Alcohol Dependence
Efficacy and Safety Evaluating Study of Odelepran for the Use in Patient With Alcohol Dependence
The purpose of this study was to assess efficacy and safety of the study drug Odelepran, 125 mg as compared to placebo in the treatment of alcohol dependence in adult outpatients.
- Trial name
- NCT03663374
- Testing
- Odelepan
- Where
- 22 sites in Kazakhstan, Russia
- Volunteers
- 644 people
- Sponsor
- R-Pharm
Prescription Opioid Misuse
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
The goal of this study is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention.
- Trial name
- NCT05209191
- Testing
- Student Athlete Wellness Portal
- Where
- 5 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Real Prevention, 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
Alcohol Use Disorder, Post Traumatic Stress Disorder
CCTAP: Cognitive Control Training for Treatment of AUD-PTSD
The primary objective of this study is to evaluate the feasibility of the revised brain training program with individuals diagnosed with Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).
- Trial name
- NCT03200028
- Testing
- Computerized Plasticity-Based Adaptive Cognitive Training
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Posit Science Corporation
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 Overdose
Pharmacokinetic (PK) Evaluation of Nalmefene Formulations
This study is designed to characterize the PK of nalmefene following IV bolus and IM injections using nalmefene 0.5 mg (0.94% MgCl2) and IV bolus of 0.5 mg nalmefene hydrochloride injection in healthy subjects.
- Trial name
- NCT07543276
- Testing
- Nalmefene + 0.94% MgCl2, Nalmefene Hydrochloride Injection
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Knoa Pharma LLC
Hepatitis C, Opioid-Related Disorders
Drug-Drug Interaction Study Between Telaprevir and Buprenorphine
The purpose of this study is to investigate the drug-drug interaction potential between telaprevir and buprenorphine/naloxone. An understanding of the interaction potential will help to determine whether buprenorphine dose…
- Trial name
- NCT01275599
- Testing
- telaprevir, buprenorphine/naloxone
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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 Dependence
A Study in the Treatment of Alcohol Dependence.
H8R-MC-HJAQ is a Phase 2, parallel, double-blind, randomized study comparing LY686017 with placebo in a 12-week trial that includes Medical Management.
- Trial name
- NCT00805441
- Testing
- LY686017
- Where
- 21 sites in United States
- Volunteers
- 190 people
- Sponsor
- Eli Lilly and Company
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
Neonatal Abstinence Syndrome
Study to Collect Data for Neonatal Abstinence Syndrome (NAS) and Evaluate the Automated Data Collection Process
Substance abuse during pregnancy is on the rise through both prescribed and illicit use of controlled substances, which has increased neonatal abstinence syndrome (NAS).
- Trial name
- NCT06303986
- Testing
- NeoMonki
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Rekovar Inc.
Opioid Dependence, on Agonist Therapy
Efficacy of BNX Sublingual Tablets Versus BNX Sublingual Film for Treatment of Opioid-Dependent Adults
The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared…
- Trial name
- ISTART (NCT01908842)
- Testing
- BNX sublingual tablets, BNX sublingual film, Buprenorphine
- Where
- 36 sites in United States
- Volunteers
- 759 people
- Sponsor
- Orexo AB
Substance Use Disorders, Alcohol Use Disorders
DEVELOPMENT OF A NOVEL PEER RECOVERY SUPPORTER TRAINING PLATFORM
This study tests an online training platform for peer recovery support specialists, people in recovery who support others with alcohol and other substance use problems.
- Conditions
- Substance Use Disorders, Alcohol Use Disorders, Recovery Support Services, Peer Recovery Coaching
- Trial name
- NCT07044531
- Testing
- Training-as-Usual (TAU), TDPP-A (Asynchronous Platform), TDPP-Z (Hybrid)
- Where
- United States
- Volunteers
- 450 people
- Sponsor
- Thrive Digital Health, 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
Alcoholic Hepatitis
Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy
The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.
- Trial name
- AH (NCT01912404)
- Testing
- IDN-6556
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Conatus Pharmaceuticals Inc.