Clinical trials: Narcotic-Related Disorders
Drug Dependence
Extended Release Naltrexone for Opioid-Dependent Youth
The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).
- Trial name
- NCT01843023
- Testing
- Extended Release Naltrexone, Psychosocial Treatment, Buprenorphine
- Where
- 2 sites in United States
- Volunteers
- 288 people
- Sponsor
- Friends Research Institute, Inc.
Opioid-Related Disorders, Heroin Dependence
Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder
The overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the University of Minnesota towards developing novel paired-neuromodulation approaches using transcrancial direct…
- Conditions
- Opioid-Related Disorders, Heroin Dependence, Morphine Dependence
- Trial name
- NCT04495673
- Testing
- Transcranial Direct Current Stimulation (tDCS), Cognitive Training
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Minnesota
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-use Disorder
Disclosure Intervention for People in Recovery From Opioid Use Disorder
Many people with substance use disorders struggle with decisions regarding whether to disclose to others that they have a history of substance use and/or are in recovery.
- Trial name
- NCT04836247
- Testing
- Disclosing Recovery: A Decision Aid and Toolkit, Mindfulness
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Delaware
Opiate Dependence, Heroin Dependence
Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone
In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial.
- Trial name
- Depot-BNT (NCT00577408)
- Testing
- depot naltrexone, Oral Naltrexone
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- New York State Psychiatric Institute
HIV, Opioid Dependence
Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
To conduct a randomized clinical trial (RCT) of a community-friendly behavioral intervention designed to reduce HIV risk behavior among injection drug users (IDUs) in drug treatment by comparing risk-behavior outcomes of four…
- Trial name
- NCT01741350
- Testing
- Community-friendly Health Recovery Program, Time-and-Attention-Matched Control Condition
- Where
- United States
- Volunteers
- 304 people
- Sponsor
- University of Connecticut
Heroin Dependence, Nicotine Dependence
Pioglitazone for Heroin and for Nicotine Dependence
The goal of the proposed research is to improve the effectiveness of treatments for opioid and for nicotine dependence by testing a novel pharmacological strategy.
- Trial name
- NCT01395797
- Testing
- PIO
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Opiate Addiction, Pregnancy
Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy
This study is a pharmacodynamic study in pregnant women evaluating the relationship between buprenorphine concentration and outcome such as opioid withdrawal symptoms , NAS scores, neurodevelopmental and neuroanatomic outcomes.
- Trial name
- NCT03831113
- Testing
- Magnitude Group, Frequency Group
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Steve N. Caritis, MD
Heroin Dependence, Opioid-Related Disorders
Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
The purpose of this study is to compare the effectiveness of extended-release naltrexone (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC jails.
- Trial name
- XOR (NCT01999946)
- Testing
- Extended-Release Naltrexone
- Where
- 2 sites in United States
- Volunteers
- 217 people
- Sponsor
- NYU Langone Health
Heroin Dependence
Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone
The study is designed to compare the abuse liabilities of intranasal buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine.
- Trial name
- NCT01760473
- Testing
- Intranasal challenge drug
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Opioid-use Disorder, HIV-1-infection
Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1
HIV infection, as well as exposure to opioids (including heroin), are associated with systemic immune activation including increased microbial translocation from the gut.
- Conditions
- Opioid-use Disorder, HIV-1-infection, Immune Activation, Inflammation
- Trial name
- AMOHI-1 (NCT04480554)
- Testing
- Methadone, Buprenorphine/naloxone, XR-Naltrexone
- Where
- 2 sites in United States, Vietnam
- Volunteers
- 78 people
- Sponsor
- University of Pennsylvania
Post Traumatic Stress Disorder, Opioid-use Disorder
Prolonged Exposure Therapy for PTSD and Opioid Use Disorder
Among patients with opioid use disorder (OUD), 90% report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD).
- Trial name
- NCT04104022
- Testing
- Prolonged Exposure Therapy, Attendance-based monetary incentives
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- University of Vermont
Opioid Use Disorder
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus…
- Trial name
- NCT02032433
- Testing
- Extended-Release Naltrexone, Buprenorphine-Naloxone
- Where
- 8 sites in United States
- Volunteers
- 570 people
- Sponsor
- NYU Langone Health
Opioid-Induced Constipation (OIC)
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain over a 6-month period.
- Trial name
- NCT01395524
- Testing
- NKTR-118
- Where
- 116 sites in United States, Australia and 2 more
- Volunteers
- 302 people
- Sponsor
- AstraZeneca
Opioid-Related Disorders
Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Treating Opioid Patients' Pain and Sadness (TOPPS) focuses on the relationship of pain, depression, opioid and other substance misuse, and functioning.
- Trial name
- TOPPS (NCT03698669)
- Testing
- Treating Opioid Patients' Pain and Sadness (TOPPS), Health Education (HE)
- Where
- 2 sites in United States
- Volunteers
- 163 people
- Sponsor
- Boston University
Opioid Use Disorder, Infectious Disease
Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations
This is a 5-year Hybrid Type 1 Effectiveness-Implementation Randomized Control Trial (RCT) that compares two models of linking and retaining individuals recently released from justice involvement to the continuum of…
- Conditions
- Opioid Use Disorder, Infectious Disease, Risk Reduction Behavior, Substance Use
- Trial name
- ACTION (NCT05286879)
- Testing
- Patient Navigator, Mobile Health Unit
- Where
- 3 sites in United States
- Volunteers
- 601 people
- Sponsor
- Yale University
Opioid-use Disorder
Project STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention Through NAvigation)
Project STAMINA is a clinical trial that seeks to establish effectiveness of a telemedicine approach for linking syringe exchange clients to medications for opioid use disorder.
- Trial name
- STAMINA (NCT04575324)
- Testing
- Telemedicine Linkage Intervention
- Where
- United States
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Chestnut Health Systems
Opioid-induced Constipation
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
- Trial name
- NCT01443403
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 244 people
- Sponsor
- Shionogi
Opioid-use Disorder
A Strategy to Improve Success of Treatment Discontinuation in Buprenorphine Responders
This study is an open--label randomized outpatient trial to evaluate feasibility and efficacy of rapid buprenorphine (BUP) discontinuation followed by brief course of treatment with long--acting naltrexone (XR--NTX) and to…
- Trial name
- NCT03232346
- Testing
- Vivitrol, Buprenorphine
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Opioid Overdose
Vaped Marijuana to Attenuate Naloxone-Precipitated Withdrawal
The goal of the proposed, proof-of-concept study is to test the combined effects of vaporized marijuana [Delta-9-tetrahydracannabinol (THC)] with NLX as a proof of concept towards the possible development of a combined overdose…
- Trial name
- NCT05114460
- Testing
- Naloxone, Marijuana
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- New York State Psychiatric Institute