Clinical trials: Substance-Related Disorder
Nicotine Dependence, Nicotine Dependence, Cigarettes
Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers
A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.
- Conditions
- Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
- Trial name
- NCT03593239
- Testing
- Tobacco flavored JUUL 1.7% ENDS, Tobacco flavored JUUL 5% ENDS, Mint flavored JUUL 1.7% ENDS
- Where
- New Zealand
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Juul Labs, Inc.
AMD, nAMD
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD).
- Conditions
- AMD, nAMD, Wet Age-related Macular Degeneration, wAMD
- Trial name
- ATMOSPHERE (NCT04704921)
- Testing
- ABBV-RGX-314, Ranibizumab (LUCENTIS®)
- Where
- 89 sites in United States
- Volunteers
- 671 people
- Sponsor
- AbbVie
Opioid Induced Bowel Dysfunction
Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain
The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.
- Trial name
- NCT01122030
- Testing
- Naldemedine
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Shionogi
Baseline Epidemiologic Assessment
Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)
The main objectives of this study are to provide surveillance/descriptive data to (a) assess utilization of MorphaBond ER and selected comparators overall and by age group and census regions using nationally-projected quarterly…
- Trial name
- BEAD-MB (NCT04033094)
- Testing
- MorphaBond ER, Comparator Drug
- Where
- United States
- Volunteers
- 17,566 people
- Sponsor
- Daiichi Sankyo
Opioid Use Disorder, Severe, Opioid Use Disorder, Moderate
SUBLOCADE Rapid Initiation Extension Study
A single center, open-label SUBLOCADE treatment extension study in which up to 25 participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.
- Trial name
- NCT04060654
- Testing
- Sublocade
- Where
- United States
- Volunteers
- 17 people
- 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 Disorders
Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and…
- Trial name
- NCT02651584
- Testing
- CAM2038 SC injection, SL BPN/NX tabs
- Where
- 36 sites in United States
- Volunteers
- 428 people
- Sponsor
- Braeburn Pharmaceuticals
Alcoholism, Alcohol Dependence
Usability Study for SOBERLINK System
The Soberlink Cellular device, in its original packaging, along with the QuickStart guide will be provided to the end user in a simulated home use environment or by Rx in clinic.
- Trial name
- NCT02650180
- Testing
- Soberlink Cellular Device
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Soberlink Healthcare LLC
Opioid Use Disorder
Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons
This study will examine the safety and efficacy of the O'Neil Long Acting Naltrexone Implant (OLANI) in persons with opioid dependency who are seeking relapse-prevention treatment.
- Trial name
- GM0020 (NCT05382091)
- Testing
- naltrexone implant
- Volunteers
- 250 people
- Sponsor
- Go Medical Industries Pty Ltd
Opioid-use Disorder, Opioid Withdrawal
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
- Trial name
- RESTORE (NCT05053503)
- Testing
- Sparrow Ascent Therapy System, Lofexidine, Extended-release injectable naltrexone
- Where
- 4 sites in United States
- Volunteers
- 108 people
- Sponsor
- Spark Biomedical, Inc.
Substance Abuse Detection
Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR)
The purpose of this study is to compare the risk of shopping behavior of tapentadol immediate release with the risk of shopping behavior of oxycodone immediate release.
- Trial name
- NCT01545778
- Testing
- Tapentadol IR, Oxycodone IR
- Volunteers
- 646,620 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Mental Health
An Evaluation of Innerview™, a Web-based Tool to Support the Integration of Mental Health in the Primary Care Setting
Innerview can address some of the challenges of integrating mental health and primary care by accurately and reliably collecting mental health evidence and activities directly from patients, and then organizing and automating…
- Trial name
- NCT02025647
- Where
- 5 sites in United States
- Volunteers
- 139 people, healthy volunteers welcome
- Sponsor
- Pearson/Clinical Assessment
Cocaine Use Disorder
A Study to Investigate the Interaction Between TMP-301 and Cocaine.
This will be a randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral TMP-301, given concurrently with cocaine.
- Trial name
- NCT06648668
- Testing
- TMP-301
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Tempero Bio, Inc.
Opioid-use Disorder, Opioid Withdrawal
Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.
- Trial name
- NCT04731935
- Testing
- Sparrow Therapy System
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Spark Biomedical, Inc.
Healthy, Healthy Volunteer
NTI164 Human PK Study
This study is looking at how a new cannabis compound with extremely low THC (0.08%), NTI164, is metabolised in the body and how it is excreted in urine over time (up to 28 days) in healthy adult volunteers.
- Trial name
- NCT06713447
- Testing
- NTI164
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Fenix Innovation Group
Opiate-Related Disorders, Opiate Substitution Treatment
A Chatbot To Support Substance Use Recovery
The goal of this clinical trial is to learn if/how an AI chatbot can support patients who in recovery for substance use, specifically those who are receiving medication for opioid use disorder.
- Trial name
- NCT06845878
- Testing
- chatbot
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Dimagi Inc.
Opioid Use Disorder (OUD)
A Safety Study of AZD4041 in Healthy Participants
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study in healthy male and female adult participants.
- Trial name
- NCT05233085
- Testing
- AZD4041
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Opioid-induced Constipation (OIC)
A Study to Assess the Safety, Tolerability and Clinical Activity of TD-1211 in Patients With Opioid-Induced Constipation
A dose-escalation study to assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation.
- Trial name
- NCT01333540
- Testing
- TD-1211
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- Glycyx Therapeutics
Sexual Violence, Substance Use
Primary Prevention of Sexual Violence Among College Students
This project is designed to address the urgent need for an effective primary prevention approach to the problem of sexual violence among college students.
- Conditions
- Sexual Violence, Substance Use, Substance Abuse
- Trial name
- NCT03037866
- Testing
- LifeSkills Training for College
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- National Health Promotion Associates, Inc.
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