Clinical trials: Substance-Related Disorder
Opioid Dependence, Methadone Withdrawal Syndrome
Pilot Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients
The primary objective of this study is to assess QTc (an interval of the heart rhythm) interaction effects between lofexidine and methadone.
- Trial name
- NCT01558934
- Testing
- Lofexidine HCl
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Tobacco Dependence
Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum
Single-dose pharmacokinetics with a new oral nicotine replacement product and Nicorette® gum.
- Trial name
- NCT01152736
- Testing
- Nicotine
- Where
- Sweden
- Volunteers
- 19 people
- Sponsor
- McNeil AB
Opioid Use Disorder
Reward-Based Recovery Outcomes Management for Opioid Use Disorder
A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in…
- Trial name
- NCT04669249
- Testing
- PROCare
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medical Decision Logic, Inc.
Tobacco Dependence
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking.
- Trial name
- NCT02355665
- Testing
- Nicotine Spray
- Where
- 8 sites in United States
- Volunteers
- 1,198 people
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Opioid-use Disorder, Depression, Anxiety
Transcranial Photobiomodulation for the Treatment of Opioid Cravings
The investigators wish to test the hypothesis that transcranial photobiomodulation (tPBM) (i.e., 4-minutes of 810nm near-infrared light at 250 mW/cm2 by LED to the forehead at F3 or F4 versus an indistinguishable placebo…
- Conditions
- Opioid-use Disorder, Depression, Anxiety, Craving
- Trial name
- NCT04417738
- Testing
- unilateral transcranial photobiomodulation, near infrared mode
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- MindLight, LLC
Opioid Induced Constipation
Naloxegol Drug Utilization Post Authorisation Safety Study
This post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway…
- Trial name
- NCT02813148
- Testing
- Naloxegol
- Where
- 4 sites in Germany, Norway and 2 more
- Volunteers
- 17,254 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Opiate Addiction, Medication Non-adherence
Using Artificial Intelligence To Monitor Medication Adherence in Opioid Replacement Therapy
This study uses an artificial intelligence platform to automatically confirm medication ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant platform can be downloaded as an 'app' onto any…
- Conditions
- Opiate Addiction, Medication Non-adherence, Addiction, Opioid Dependence
- Trial name
- NCT02243670
- Testing
- AiCure monitoring and intervention
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- AiCure
Alcohol Use Disorder
A Study of New Treatment for Excessive Alcohol Users by Electric Stimulation of Nerves Around Ear
Alcohol Use Disorders (AUD's) are a major health and social problem. Relapse is a rule rather than an exception in alcohol dependence, leading to poor outcomes. Craving are frequently associated with relapse.
- Trial name
- NCT04106739
- Testing
- Drug Relief V(version) 2.0 Auricular Percutaneous Electrical Neural Field Stimulation (PENFS)
- Where
- India
- Volunteers
- 44 people
- Sponsor
- DyAnsys, Inc.
Alcoholic Hepatitis, Acute Alcoholic Hepatitis
MRG-001 in Patients With Alcoholic Hepatitis
The goal of this study is to test MRG-001 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of MRG-001 in patients with severe alcoholic hepatitis…
- Trial name
- NCT06307522
- Testing
- MRG-001
- Volunteers
- 32 people
- Sponsor
- MedRegen LLC
Opioid Overdose
Incidence and Predictors of Opioid Overdose and Death Among Long-Term Users of Opioid Analgesics
Retrospective study to assess incidence and predictors of opioid abuse overdose and death associated with opioid overdose among patients prescribed opioid products in long-term use.
- Trial name
- NCT02662153
- Testing
- Observation only
- Where
- 4 sites in United States
- Volunteers
- 808,455 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Heroin Addiction
Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT
The efficacy and tolerability of Eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients.
- Trial name
- METHODE (NCT02062723)
- Where
- 22 sites in Germany
- Volunteers
- 515 people
- Sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Opioid-Induced Constipation
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids.
- Trial name
- NCT00858754
- Testing
- methylnaltrexone
- Where
- 8 sites in United States, Canada and 2 more
- Sponsor
- Bausch Health Americas, Inc.
Healthy
Food Effect Study of VER-01 in Healthy Volunteers
Evaluation of pharmacokinetics, tolerability and safety of VER-01 depending on the intake a high-fat meal in healthy volunteers
- Trial name
- NCT04930796
- Testing
- VER-01
- Where
- Austria
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Vertanical GmbH
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.
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.
Constipation
Evaluation of the Efficacy and Safety of ADL5945 Once Daily for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain
Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI tract.
- Trial name
- NCT01275755
- Testing
- ADL5945 0.25 mg
- Volunteers
- 81 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Nicotine Addiction, Drug Addiction
Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.
- Conditions
- Nicotine Addiction, Drug Addiction, Drug Dependence, Substance Use Disorder
- Trial name
- NCT05440721
- Testing
- Treatment A with device Clickotine® (Active intervention), Treatment B with smoking education (control)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Click Therapeutics, Inc.
Constipation
Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).
- Trial name
- NCT00529087
- Testing
- N-methylnaltrexone bromide (MOA-728)
- Where
- 78 sites in United States
- Volunteers
- 460 people
- Sponsor
- Bausch Health Americas, Inc.
Opioid-induced Constipation
Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol
Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual…
- Trial name
- KYONAL (NCT04173858)
- Testing
- Naloxegol
- Where
- Spain
- Volunteers
- 126 people
- Sponsor
- Kyowa Kirin Farmacéutica S.L.U.