Clinical trials: Substance-Related Disorder
Opioid-induced Constipation
Efficacy and Safety of Naldemedine in the Treatment of 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
- NCT01965158
- Testing
- Naldemedine
- Where
- 65 sites in United States, Austria and 5 more
- Volunteers
- 547 people
- Sponsor
- Shionogi
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, Substance Use Disorders
Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)
The purpose of this clinical trial is to investigate Low Intensity Focused Ultrasound (LIFU) using the Exablate® Model 4000 Type 2.0/2.1 as an adjunctive neuromodulatory treatment for OUD (Opioid Use Disorder) and/or other…
- Trial name
- NCT04197921
- Testing
- Exablate Model 4000 Type 2.0/2.1
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- InSightec
Tobacco Dependence
An Exploratory Study Comparing Two Nicotine Inhalers
Subjects will be screened within 28 days before the first study treatment to confirm that they meet the requirements to participate in the trial.
- Trial name
- NCT01478230
- Testing
- Nicotine
- Where
- Sweden
- Volunteers
- 36 people
- Sponsor
- McNeil AB
Opioid Dependence, Acute Opioid Withdrawal Syndrome
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.
- Trial name
- NCT01863186
- Testing
- Lofexidine HCl, Open Label Lofexidine HCL
- Where
- 18 sites in United States
- Volunteers
- 603 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02866266
- Testing
- Retrospective database review
- Volunteers
- 183,452 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Acute-On-Chronic Liver Failure, Alcoholic Hepatitis
A-TANGO Phase 2 Study
The purpose of this research is to know if a new combination of drugs (TAK-242 and G-CSF) in combination with standard therapy for acute-on-chronic liver failure (ACLF) is more effective than standard therapy for ACLF treatment…
- Conditions
- Acute-On-Chronic Liver Failure, Alcoholic Hepatitis, Liver Cirrhosis, Alcoholic
- Trial name
- A-TANGO (NCT06890039)
- Testing
- TAK-242, G-CSF (Filgrastim)
- Where
- United Kingdom
- Volunteers
- 78 people
- Sponsor
- Yaqrit Ltd
Opioid Induced Constipation
A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC)
A Single-Blind, Pilot Study to Determine the Tolerability and Safety of TD-1211 in Subjects with Opioid-Induced Constipation
- Trial name
- NCT01401985
- Testing
- TD-1211
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Glycyx Therapeutics
Opioid-use Disorder
Pilot Research on Opioid Use Disorder
This study evaluates the effects of peripheral nerve stimulation on opioid withdrawal, craving, and use in participants with opioid use disorder (OUD) who are initiating treatment with buprenorphine/naloxone.
- Trial name
- PROUD (NCT04244227)
- Testing
- Empower Neuromodulation System
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Theranova, L.L.C.
Opioid Misuse
Decreasing Opioid Misuse and Habit-forming Behaviors Following Prescription in Patients Undergoing Cesarean Section
Background: Cesarean delivery is one of the most common obstetric procedures experienced among women who are pregnant.1 Women with Cesarean deliveries have a higher rate of peripartum opioid prescriptions and persistent opioid…
- Trial name
- NCT05461196
- Testing
- CPMRx
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Jessica Morgan
Opioid-Induced Constipation
Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been…
- Trial name
- NCT02270983
- Testing
- Linaclotide 145 micrograms, Linaclotide 290 micrograms
- Where
- 77 sites in United States
- Volunteers
- 254 people
- Sponsor
- Forest Laboratories
Generalized Anxiety Disorder
Anxiety Symptoms in Relation to Use of Hemp-derived, Full Spectrum Cannabidiol (CBD)
Generalized anxiety disorder affects about 6.8 million adults in the United States, therefore its treatment is of major public health interest.
- Trial name
- NCT05023759
- Testing
- Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 30 people
- Sponsor
- Formula30A LLC
Healthy Volunteers
A Randomised, Open-label, Three-way Crossover Study to Assess the Pharmacokinetics and Safety of Single Doses of Four Sprays of Sativex® in a Range of Oral pH Environments in Healthy Subjects
To evaluate the effect of oral pH on the pharmacokinetics (PK) of a single oromucosal dose of Sativex (four sprays containing 10.8 mg Δ9 tetrahydrocannabinol (THC) and 10 mg cannabidiol (CBD)) by comparing the PK profile of…
- Trial name
- NCT02240160
- Testing
- Sativex
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- GW Pharmaceuticals Ltd
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
Smoking Cessation, Harm Reduction
Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes
This study will evaluate a reward devaluation strategy in which smokers use the JUUL e-cigarette immediately before any combustible cigarettes (CCs) are smoked.
- Conditions
- Smoking Cessation, Harm Reduction, E-Cig Use, Cigarette Smoking
- Trial name
- RECON (NCT04188197)
- Testing
- JUUL
- Where
- 2 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Rose Research Center, LLC
Opioid Dependence
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4.
- Trial name
- NCT02038790
- Testing
- Suboxone Sublingual Film, Zubsolv sublingual tablets
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Indivior Inc.
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
Drug Overdose, Opioid-Related Disorders
Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose
RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the onset of mild, moderate, and…
- Trial name
- NCT03845699
- Testing
- Diagnostic algorithms that detects/predicts hypoventilation
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- RTM Vital Signs, LLC
Opioid Induced Constipation
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.
- Trial name
- NCT01623609
- Testing
- Naloxegol
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Substance Use, Substance Abuse
Mobile Technology to Reduce Teen Substance Misuse
The goal of this study is to test the newly expanded WisePath for Teens (WPT) for substance use app, a direct-to-consumer paired mobile phone app for iOS and Android platforms that supports parents/guardians in delivering…
- Conditions
- Substance Use, Substance Abuse, Suicide, Adolescent
- Trial name
- NCT05897164
- Testing
- WisePath for Teens, Peer Support Services (PSS), Control
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- Evidence-Based Practice Institute, Seattle, WA