Clinical trials: Substance-Related Disorder
Alcoholism
A Study of LY2940094 in Participants With Alcohol Dependency
The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce alcohol drinking in these participants.
- Trial name
- NCT01798303
- Testing
- LY2940094
- Where
- 5 sites in United States
- Volunteers
- 88 people
- Sponsor
- BlackThorn Therapeutics, Inc.
Opioid-Induced Constipation
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in…
- Trial name
- NCT01186770
- Testing
- Methylnaltrexone
- Where
- 2 sites in United States
- Volunteers
- 804 people
- Sponsor
- Bausch Health Americas, Inc.
Drug Abuse, Healthy
Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users
The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy recreational polydrug users.
- Trial name
- NCT00828659
- Testing
- Active Comparator #1, Active Comparator #2, Active Comparator #3
- Where
- Canada
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Opioid-use Disorder
Pharmacokinetic Study of Vivitrol in Healthy Participants
This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.
- Trial name
- NCT04716881
- Testing
- Naltrexone 380 MG
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Go Medical Industries Pty Ltd
Opioid-Related Disorders, Opiate Dependence
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only.
- Trial name
- NCT01848054
- Testing
- Buprenorphine/naloxone sublingual tablets, Buprenorphine
- Where
- 14 sites in United States
- Volunteers
- 313 people
- Sponsor
- Orexo AB
Analgesia, Acute Pain
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed…
- Conditions
- Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse
- Trial name
- NCT01530542
- Testing
- oxycodone hydrochloride, marketed oxycodone hydrochloride
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Pfizer
Opioid Use Disorder
iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers
This Phase 1b clinical study is evaluating iSTEP-N, an investigational extended-release implant containing naltrexone, a medication used to block the effects of opioids.
- Trial name
- iSTEP-N (NCT07064564)
- Testing
- Naltrexone implant, 14.4 grams, Naltrexone implant, 9.6 grams, Extended-release naltrexone injection, 380 mg
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Akyso Therapeutics, LLC
Alcohol Dependence
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use
The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.
- Trial name
- NCT02197598
- Testing
- nalmefene
- Where
- 3 sites in Germany
- Volunteers
- 45 people
- Sponsor
- H. Lundbeck A/S
Opioid Dependence
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
- NCT00447564
- Testing
- Probuphine
- Where
- 18 sites in United States
- Volunteers
- 163 people
- Sponsor
- Titan Pharmaceuticals
Opioid Overdose
Pharmacokinetic Evaluation of a New Naloxone Nasal Swab, Naloxone Nasal Spray, and Intramuscular Naloxone Injection in Healthy Volunteers
The study consists of two Phases with the first phase (Pilot Phase) divided into two sub phases. In each study phase, subjects will be admitted to the clinical unit from 10 hours prior to the first drug administration on Day -1…
- Trial name
- NCT05363501
- Testing
- IM Naloxone Injection, Naloxone Nasal Spray, Naloxone Nasal Swab
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pocket Naloxone Corp
Alcohol Drinking, Alcohol Intoxication
WayToServePlus: Improving Responsible Alcohol Service Ph II
Responsible beverage service (RBS) training for alcohol servers is a promising intervention for reducing driving while intoxicated (DWI) by alcohol.
- Conditions
- Alcohol Drinking, Alcohol Intoxication, Alcohol Use, Unspecified
- Trial name
- NCT05779774
- Testing
- WayToServe Plus In-service Component, WayToServe Training Only
- Where
- United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Klein Buendel, Inc.
Opioid Abuse and Addiction
Nalmefene Implant in Healthy Subjects
The goal of this clinical trial is to learn how safe either one or two nalmefene implants are after remaining implanted for 4 or 12 weeks.
- Trial name
- NCT07325279
- Testing
- 1 Nalmefene implant, 2 Nalmefene implants
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ReacX Pharmaceuticals, Inc.
Healthy
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
- Trial name
- NCT01775189
- Testing
- crushed ALO-02 30 mg/3.6 mg, crushed oxycodone IR 30 mg
- Where
- Canada
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bipolar I Disorder, Alcohol Dependence
Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol…
- Trial name
- NCT00114686
- Testing
- Quetiapine fumarate, lithium, divalproex
- Where
- 38 sites in United States
- Volunteers
- 350 people
- Sponsor
- AstraZeneca
Nalbuphine, Opioid Abuse
Oral Abuse Potential Study of Nalbuphine
The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients).
- Trial name
- NCT04018664
- Testing
- Nalbuphine HCl solution
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Trevi Therapeutics
Neonatal Abstinence Syndrome
tAN to Mitigate Withdrawal Behaviors in Neonates
This first in-human-neonates, open-label pilot trial is designed to determine whether use of tAN in newborns with NOWS receiving oral morphine allows for faster weaning of morphine and decrease morphine use altogether.
- Trial name
- NCT04588519
- Testing
- Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Spark Biomedical, Inc.
Alcohol Use Disorder
Pilot Evaluation of the Empower Neuromodulation System in AUD Patients
This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD).
- Trial name
- NCT03983317
- Testing
- Empower Neuromodulation System
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Theranova, L.L.C.
Substance Use Disorders, PTSD
A Mobile App for Peer-led Seeking Safety
Peer support is historically prominent for substance use disorder (SUD), such as the world-wide model of Alcoholics Anonymous and other 12-step groups.
- Conditions
- Substance Use Disorders, PTSD, Trauma, Emotional Dysfunction
- Trial name
- NCT03846115
- Testing
- Peer-Led Seeking Safety app, Control app
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Treatment Innovations
Alcohol Dependence
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.
- Trial name
- NCT02382276
- Testing
- Nalmefene hydrochloride
- Where
- 7 sites in Japan
- Volunteers
- 405 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Opioid-Related Disorders
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a…
- Trial name
- NCT00640835
- Testing
- Buprenorphine/naloxone Film Strip
- Where
- 3 sites in United States
- Volunteers
- 382 people
- Sponsor
- Indivior Inc.