Clinical trials: Substance-Related Disorder
Opioid Use Disorder
The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers
This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner.
- Trial name
- NCT03810495
- Testing
- naltrexone implant
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Go Medical Industries Pty Ltd
Health, Subjective, Inflammatory Response
Efficacy and Safety of Hemp-derived, Full Spectrum Cannabigerol (CBG) in Adults
The goal of this observational study is to provide exploratory research into the in vivo physiological and psychological effects, if any, of cannabigerol (CBG) in healthy human adults age 21 or over.
- Conditions
- Health, Subjective, Inflammatory Response, Adverse Effect, Side Effect
- Trial name
- NCT05743985
- Testing
- Cannabigerol
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Formula30A LLC
Substance Use Disorders (SUD)
A Single Ascending Dose Trial of CVL-936 in Healthy Subjects
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CVL-936 following single ascending oral doses in healthy subjects.
- Trial name
- NCT04232878
- Testing
- CVL-936
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Cerevel Therapeutics, LLC
Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4, Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4
Study to Evaluate the Effect of Rifampicin, Ketoconazole, and Omeprazole on the Pharmacokinetics of Sativex
Study to assess the effect of rifampicin, ketoconazole and omeprazole on the pharmacokinetics of a single dose of Sativex and to evaluate the safety of Sativex when given in combination with these other drugs.
- Conditions
- Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Known Inducer of CYP3A4, Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a Potent Inhibitor of CYP3A4, Evaluation of Pharmacokinetics of Sativex in the Absence and Presence of a CYP2C19 Inhibitor
- Trial name
- NCT01323465
- Testing
- Sativex and rifampicin, Sativex and ketoconazole, Sativex and omeprazole
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Alcoholic Liver Cirrhosis
Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study
This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).
- Trial name
- NCT02806011
- Where
- South Korea
- Volunteers
- 48 people
- Sponsor
- Pharmicell Co., Ltd.
Opioid-related Disorders, Opioid Addiction
Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02871232
- Testing
- Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion
- Volunteers
- 26,500 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Drug Addiction
Survey of Buprenorphine Use Among "Out of Care" Population in France (P04933)(COMPLETED)
This study was a survey of drug users who obtain buprenorphine from the black market and have used buprenorphine during the last month.
- Trial name
- NCT00756353
- Volunteers
- 600 people
- Sponsor
- Indivior Inc.
Pain, Pain Syndrome
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Diabetic Polyneuropathy
Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates…
- Conditions
- Pain, Pain Syndrome, Pain, Chronic, Chronic Pain
- Trial name
- NCT06071975
- Testing
- Adezunap (AP707)
- Where
- Germany
- Volunteers
- 558 people
- Sponsor
- Apurano Pharmaceuticals GmbH
Opioid-Related Disorders, Opiate Addiction
An Observational Study to Develop Algorithms for Identifying Opioid Abuse and Addiction Based on Admin Claims Data
The purpose of this study is to develop and validate a classification model based entirely on medical claims data that can be used to identify patients experiencing prescription opioid abuse/addiction among patients receiving…
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02667262
- Testing
- Algorithm to identify patients experiencing opioid abuse/addiction
- Volunteers
- 1,667 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Cannabis Abuse
Drug-Drug Interaction Between THC and AEF0117
This trial is a single center, double blind, placebo-controlled trial in healthy male and female recreational cannabis users with placebo and AEF0117 dosed in a fixed sequence.
- Trial name
- DDI (NCT06395688)
- Testing
- 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aelis Farma
Fibromyalgia, Cannabis
Phase II Clinical Trial, Use of KL16-012 in Women With Fibromyalgia Refractary to Conventional Treatment.
A double blind randomized placebo controlled trial in 44 women with fibromyalgia and persistent symptoms in spite of use of conventional pharmacotherapy, will be performed in the city of Valparaiso.
- Trial name
- NCT04239469
- Testing
- KL16-012
- Volunteers
- 44 people
- Sponsor
- Knop Laboratorios
Cocaine Use, Cocaine Intoxication
Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)
This is a Phase 2 single-blind, randomized, multicenter study to compare the efficacy and safety of a single dose of TNX-1300 to placebo with usual care in patients with acute cocaine intoxication within the emergency department…
- Conditions
- Cocaine Use, Cocaine Intoxication, Cocaine Toxicity, Cocaine Abuse
- Trial name
- CATALYST (NCT06045793)
- Testing
- TNX-1300 (Injection)
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Hepatorenal Syndrome
A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
- Trial name
- NCT01143246
- Testing
- Terlipressin
- Where
- 73 sites in United States, Canada
- Volunteers
- 196 people
- Sponsor
- Mallinckrodt
Alcohol Use Disorder
A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder
This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo.
- Trial name
- NCT02511886
- Testing
- Arbaclofen Placarbil
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Indivior Inc.
Addiction, Behavioral Addiction
Mobile Health for Problematic Behaviors and Substance Use
The aim of the study is to evaluate the effectiveness of long-term and short-term app-based self-guided psychological interventions to reduce craving and lapse risk in problematic behaviors (compulsive sex, pornography…
- Conditions
- Addiction, Behavioral Addiction, Nicotine Addiction, Nicotine Dependence
- Trial name
- NCT05434429
- Testing
- mobile application
- Where
- Poland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PredictWatch
Alcohol Use Disorder
Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms
Randomized, multi-center, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized to receive either 0.33 mg AD04 or placebo orally twice-daily for 24 weeks in conjunction with brief…
- Trial name
- ONWARD (NCT04101227)
- Testing
- AD04 (ondansetron), Companion Diagnostic for Genetic Testing, Brief Psychological Counseling
- Where
- 25 sites in Bulgaria, Croatia and 5 more
- Volunteers
- 302 people
- Sponsor
- Adial Pharmaceuticals
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-Induced Constipation
Safety and Preliminary Efficacy of BGP345A in Constipation Due to Opioid-based Medications
The purpose of this study is to assess safety and preliminary efficacy of BGP345A in patients with constipation due to the use of opioid-based medications for the management of chronic non cancer pain.
- Trial name
- OIC1 (NCT05133076)
- Testing
- Lactobacillus gasseri BGP345A
- Where
- 4 sites in France
- Volunteers
- 14 people
- Sponsor
- BioGaia Pharma AB
Substance-Related Disorders
Phone App for Grounding
The goal of this project is to continue to develop a smartphone application ("app") to help youth from ages 18-25 who have a substance abuse problem.
- Trial name
- NCT03258905
- Testing
- Grounding enhanced app, Grounding text-only app
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Treatment Innovations
Opioid Use Disorder
Feasibility Study of Novel Prescription Digital Therapeutic Supporting Unobserved Buprenorphine Initiation & Adherence
The purpose of this study is to assess feasibility of an at-home digital therapy designed to support buprenorphine initiation and adherence.
- Trial name
- NCT05412966
- Testing
- PEAR-002B, reSET-O
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Pear Therapeutics, Inc.