Clinical trials: Substance-related Disorders
Moderate or Severe Opioid Use Disorder
A Multiple Dose Opioid Challenge Study
Multi-site, randomized, double-blind, repeat-dose Phase 2 study to evaluate the degree and duration of action of multiple doses of CAM2038 in blocking the effects of hydromorphone in patients with moderate or severe opioid use…
- Trial name
- NCT02611752
- Testing
- CAM2038
- Where
- 3 sites in United States
- Volunteers
- 47 people
- Sponsor
- Braeburn Pharmaceuticals
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.
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.
Alcohol Use Disorder (AUD), Substance Use Disorders
The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use
This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder…
- Trial name
- NCT04925570
- Testing
- W-SUDs, Digitally-delivered Psychoeducation
- Where
- United States
- Volunteers
- 258 people
- Sponsor
- Woebot Health
Substance Use Disorders
Automated Assessment Using Facial Coding
Transition-age youth (TAY) from ages 18-26 are vulnerable to substance substance use disorder (SUD). This developmental period, termed "emerging adulthood" includes leaving home, entering college or working for the first time…
- Trial name
- R44DA042640 (NCT03551886)
- Testing
- Advanced Emotion App, Basic Emotion App
- Where
- United States
- Volunteers
- 153 people
- Sponsor
- Treatment Innovations
Tobacco Use Disorder
To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 4 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 4mg) in healthy smokers under fasting…
- Trial name
- NCT03543137
- Testing
- Nicotine Prototype Mini lozenge, Nicorette Mini Lozenge
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Schizophrenia, Drug Abuse
A Pilot, Proof-of-concept Cohort Study of the Prevalence of Comorbid Mental Illness and Substance Abuse
The prevalence estimates for specific mental disorders and illicit drugs have been separately reported in U.S. government surveys.
- Conditions
- Schizophrenia, Drug Abuse, Anxiety Disorder, Bipolar Disorder
- Trial name
- NCT02476877
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Advanced Clinical Laboratory Solutions, Inc.
Healthy
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.
- Trial name
- NCT01746901
- Testing
- intact ALO-02 60 mg/7.2 mg, crushed ALO-02 60 mg/7.2 mg, crushed oxycodone IR 60 mg
- Where
- Canada
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Pfizer
Withdrawal Symptoms
A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects
This single-center study is a randomized, double-blind, active-controlled, multiple-dose, parallel group study to evaluate the potential withdrawal effects, safety and tolerability, and pharmacokinetic and pharmacodynamic effects…
- Trial name
- NCT02391571
- Testing
- Oxycodone/Naltrexone Capsules, Oxycodone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Elite Laboratories, Inc
Nicotine Dependence, Nicotine Dependence, Cigarettes
Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.
A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers
- Conditions
- Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
- Trial name
- NCT03700112
- Testing
- JUUL Virginia Tobacco flavored 5.0% ENDS, PMI iQOS Heat sticks, Reynolds VUSE Solo ENDS - Original
- Where
- New Zealand
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Juul Labs, Inc.
Opioid Users
Abuse Potential Study of PF-00345439
This study will determine the relative abuse potential of intact and chewed PF-00345439 (Oxycodone Extended-Release Capsules) compared to crushed oxycodone HCL immediate release (IR) tablets and placebo administered orally to…
- Trial name
- NCT01986283
- Testing
- Capsule, PF-00345439, oxycodone
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Pain Therapeutics
Opioid-use Disorder
Single Ascending Dose Study of ALA-1000
An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects.
- Trial name
- NCT04122755
- Testing
- ALA-1000, buprenorphine sublingual film
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Alar Pharmaceuticals Inc.
Alcoholic Intoxication
WayToServe Español: Online Responsible Beverage Service Training for Spanish-Speaking Servers
Responsible Beverage Service Training (RBS) has been shown to be effective and recent research by this research team has shown that online RBS training (WayToServe®) was more effective, particularly over time, than usual and…
- Trial name
- WTS-E (NCT03001024)
- Testing
- Implementation of WayToServe Español, Usual and Customary RBS Training
- Where
- 2 sites in United States
- Volunteers
- 79 people
- Sponsor
- Klein Buendel, Inc.
Alcoholism
ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as…
- Trial name
- NCT01218997
- Testing
- Medisorb naltrexone 380 mg, Oral naltrexone 50 mg
- Volunteers
- 436 people
- Sponsor
- Alkermes, Inc.
Attention Deficit Hyperactivity Disorder, Substance Use Disorders
CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders
The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.
- Trial name
- NCT01431235
- Testing
- cognitive behavioral therapy for treating ADHD symptoms
- Where
- Netherlands
- Volunteers
- 184 people
- Sponsor
- Arkin
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Opioid Use Disorder, Opioid-related Disorders
Open-Label Treatment Extension Study
Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.
- Trial name
- NCT02896296
- Testing
- RBP-6000
- Where
- 29 sites in United States
- Volunteers
- 208 people
- Sponsor
- Indivior 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
Drug Abuse
Testing a Multilevel Preventive Intervention in Youth Courts
The proposed research is designed to adapt and test an evidence-based drug abuse prevention approach for use in youth courts among first-time, non-violent, adolescent offenders.
- Trial name
- NCT02764099
- Testing
- Life Skills Training
- Volunteers
- 423 people, healthy volunteers welcome
- Sponsor
- National Health Promotion Associates, Inc.
Opioid Related Disorders, Opiate Addiction
Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could…
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02920775
- Testing
- Non-interventional study - retrospective database review
- Volunteers
- 360,000 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)