Clinical trials: Substance Related Disorder
Opioid Overdose
Pharmacokinetics (PK) and Safety of Multiple Doses of Intranasal Naloxone in Healthy Adults
This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
- Trial name
- NCT05377255
- Testing
- 16 mg naloxone AP003, 8 mg naloxone NARCAN Nasal Spray
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Substance Use, Stress
Automating Peer Learning to Reduce Alcohol Use and Related Deviant Behavior in Secondary School
Deviant peer affiliation is one of the most important predictors of alcohol use in adolescence. These affiliations arise when socially marginalized youth self-aggregate and reinforce alcohol use and other deviant activity (i.e.…
- Conditions
- Substance Use, Stress, Relation, Interpersonal, Bullying
- Trial name
- PeerLearning (NCT04478240)
- Testing
- PeerLearning.net
- Where
- United States
- Volunteers
- 924 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Opioid Overdose
Clinical Outcomes From Nalmefene
The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.
- Trial name
- COINED (NCT05808881)
- Testing
- Nalmefene Hydrochloride Injection, Naloxone Hydrochloride Injection
- Sponsor
- Purdue Pharma LP
Opioid-Related Disorders, Opiate Addiction
A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire
The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- POMAQ (NCT02678507)
- Testing
- Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- Volunteers
- 800 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Opioid Addiction
Observational Study to Evaluate Levomethadone Safety and Effectiveness in Subjects Under Opioid Maintenance Treatment
Multicentre, prospective, observational, non-interventional, open- ended trial, collecting data from male and female patients aged ≥ 18 years, with a diagnosis of opioid addiction according to ICD-10 (F11.2), treated with…
- Trial name
- LEVOPROACT (NCT03685162)
- Where
- Italy
- Volunteers
- 103 people
- Sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
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)
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases
In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support…
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02897414
- Testing
- Surveillance of state medical examiner databases
- Volunteers
- 13,015 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Suicide, Suicide, Attempted
Drivers of Suicide Mobile App Study
The central purpose of this project is to evaluate and facilitate access to evidence-based best practices for individuals struggling with suicidal ideation and co-occurring behavioral problems, including alcohol misuse, and…
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation, Alcohol Use Disorder
- Trial name
- NCT05427734
- Testing
- WisePath for Adults, Active-Control app + electronic wellness resources brochure
- Where
- United States
- Volunteers
- 127 people
- Sponsor
- Evidence-Based Practice Institute, Seattle, WA
Chronic Pain, Opioid Induced Constipation
Naloxone SR Capsules in Patients With Opioid Induced Constipation
For many patients taking opioids for pain relief one of the most distressing side effects is constipation. Naloxone is effective in the reversal of the effects of opioids and is used following opioid overdose.
- Trial name
- NCT00984334
- Testing
- Naloxone SR 5 mg capsules, Naloxone SR 10 mg capsules, Naloxone SR 20mg capsules
- Where
- 8 sites in Germany, United Kingdom
- Volunteers
- 40 people
- Sponsor
- S.L.A. Pharma AG
Cocaine Dependence, Cocaine Addiction
A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction
Subjects will be randomly assigned to receive either one of the two potential dose combinations of the study medications or placebo over 6 weeks.
- Trial name
- NCT00567814
- Testing
- Metyrapone, Oxazepam
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Embera NeuroTherapeutics, Inc.
Healthy
Single and Multiple Dose Study of VER-01 in Healthy Volunteers
Evaluation of pharmacokinetics, tolerability and safety of VER-01 in healthy volunteers
- Trial name
- NCT04930809
- Testing
- VER-01
- Where
- Austria
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Vertanical GmbH
Opioid Use Disorder
A Study of Brenipatide in Participants With Opioid Use Disorder
The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone.
- Trial name
- RENEW-Op-1 (NCT07420283)
- Testing
- Brenipatide, Buprenorphine
- Where
- 61 sites in United States, Canada and 2 more
- Volunteers
- 465 people
- Sponsor
- Eli Lilly and Company
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.
Substance Use Disorders, Behavioral Health
Mindfulness and Meditation-Based Relapse Prevention for Substance Use Disorders
Mindfulness and meditation based relapse prevention has been proposed as an adjunctive approach for individuals with substance use disorders (SUDs).
- Conditions
- Substance Use Disorders, Behavioral Health, Addiction Psychological, Addiction Disorders
- Trial name
- MBRP-SUD (NCT07417579)
- Testing
- Mindfulness and Meditation-Based Relapse Prevention Program
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Bout Me Healing
Longitudinal Studies, Prospective Studies
Clinical Time and Temporal Dynamics Study (CLIN-TIME)
TH-CLINICAL-TIME is a prospective, longitudinal observational study evaluating how changes in clinical measurements over time may help researchers better understand patient health trajectories and clinically meaningful outcomes.
- Conditions
- Longitudinal Studies, Prospective Studies, Biomarkers, Predictive Value of Tests
- Trial name
- CLIN-TIME (NCT07812831)
- Testing
- No Study-Assigned Intervention
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
Opioid Abuse
Study of the Abuse Liability of Oxycodone HCl/Niacin in Subjects With a History of Opioid Abuse
The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid…
- Trial name
- NCT00699010
- Testing
- Acurox 5/30mg taken first, Oxycodone 5mg taken first
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Acura Pharmaceuticals Inc.
Evaluation of Abuse Potential of Sativex
Abuse Potential of Sativex
This crossover study with six treatment sessions is to evaluate the abuse potential of three doses of Sativex as compared to Marinol and placebo, in subjects with a history of recreational marijuana use.
- Trial name
- NCT01323569
- Testing
- Sativex, Marinol
- Where
- Canada
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Drug Abuse
A Study to Evaluate Abuse Potential of Istradefylline
This study is to evaluate the abuse potential of single-doses of istradefylline compared to placebo and phentermine in recreational stimulant users.
- Trial name
- NCT02609477
- Testing
- Istradefylline, Phentermine 45 mg
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
Alcoholism
Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care
The primary objective is to investigate differences in the alcohol consumption pattern between alcohol addicts receiving conventional treatment and those who receive a combination of conventional treatment and TripleA.
- Trial name
- NCT03195894
- Testing
- TripleA
- Volunteers
- 115 people
- Sponsor
- Kontigo Care AB
Opioid Overdose, Opioid Use Disorder
Safety, Tolerability, and Pharmacokinetics of CSX-1004
This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult…
- Trial name
- NCT06005402
- Testing
- CSX-1004
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cessation Therapeutics, Inc.