Clinical trials: Narcotic-Related Disorders
Opioid Induced Constipation (OIC)
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with…
- Trial name
- NCT00600119
- Testing
- NKTR-118
- Where
- 33 sites in United States
- Volunteers
- 207 people
- Sponsor
- AstraZeneca
Opiate Dependence
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under…
- Trial name
- NCT02477267
- Testing
- SL spray, SL film
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Opioid Use Disorder
PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study
The goal of this clinical trial is to learn if it is feasible to use PEX010 for the treatment of opioid use disorder in adults. The study will also assess the safety of PEX010.
- Trial name
- NCT06608459
- Testing
- PEX010-Assisted Therapy
- Volunteers
- 10 people
- Sponsor
- Filament Health Corp.
Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
A Brief Negotiation Interview Chatbot to Improve Buprenorphine Engagement Among Justice-Involved Individuals
Primary Objective: Conduct pilot study to assess effects of brief negotiation interview (BNI) Chatbot among individuals involved in the Connecticut criminal justice system with opioid use disorder (OUD).
- Conditions
- Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe, Criminal Behavior
- Trial name
- BNICHAT (NCT04982627)
- Testing
- BNI Chatbot, OUD Education & Treatment Resources
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Center for Progressive Recovery, LLC
Opioid Dependence, Opioid Related Disorders
A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse
This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male and female subjects with an American Psychiatric Association Diagnostic and Statistical Manual DSM-IV-TR diagnosis of cocaine abuse.
- Conditions
- Opioid Dependence, Opioid Related Disorders, Cocaine Dependence
- Trial name
- RBP-8000 (NCT01846481)
- Testing
- RBP-8000 100 mg, Cocaine, RBP-8000 200 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Opioid Use Disorder
A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The primary purpose of this study was to assess the safety and tolerability of multiple doses of buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose of ASP8062.
- Trial name
- NCT04447287
- Testing
- ASP8062, buprenorphine/naloxone
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pain, Pain, Acute
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
This study will test the quality of opioid-related physician care decisions using a patient-simulation based measurement and feedback approach that combines multiple-choice care decisions with real-time, personalized scoring and…
- Conditions
- Pain, Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Trial name
- NCT04080037
- Testing
- Quality IQ Patient Simulations
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Opioid-Related Disorders
Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users
To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when crushed and administered intranasally to non dependent…
- Trial name
- NCT01759446
- Testing
- Generic H/A taken first, Vycavert taken first, Generic H/A plus i taken first
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Acura Pharmaceuticals Inc.
Opioid Dependence
A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
- Trial name
- PRO-810 (NCT00768482)
- Testing
- Probuphine (buprenorphine implant), Sublingual Buprenorphine
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Titan Pharmaceuticals
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.
Opioid Withdrawal (Disorder), Opioid Use Disorder
A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects
The goal of this clinical study is to evaluate the pharmacokinetic (PK), safety, and tolerability of LUCEMYRA in adolescents age ≥12 to <18 years old abruptly discontinuing opioid use.
- Trial name
- NCT06711640
- Testing
- LUCEMYRA (lofexidine) tablets
- Where
- United States
- Sponsor
- USWM, LLC (dba US WorldMeds)
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
Opioid-induced Constipation
Study of Methylnaltrexone in Opioid-Induced Constipation Patients
This is a multicenter, randomized, double-blind , placebo-controlled trail to investigate the safety and efficacy of subcutaneous methylnaltrexone for treating opioid-induced constipation in patients with advanced illness.
- Trial name
- NCT02574819
- Testing
- Methylnaltrexone (MNTX)
- Where
- 12 sites in China
- Volunteers
- 198 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Substance Use Disorders, Opioid Use Disorder
Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD)…
- Conditions
- Substance Use Disorders, Opioid Use Disorder, Alcohol Use Disorder, Cocaine Use Disorder
- Trial name
- EDITOR (NCT06434818)
- Testing
- EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance), CBOT with olfactory stimulants & OFC tasks
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Evon Medics LLC
Opioid Use Disorder
Brain Training for Substance Use Disorders
Participants play games designed to train visual attention towards natural, non-drug-related scenarios. A biofeedback loop between gameplay and an electroencephalogram (EEG) system monitors game performance and guides game…
- Trial name
- NCT06870110
- Testing
- Bias Modification Biofeedback
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Neurotype Inc.
Opioid Use Disorder
AvertD Post-Approval Study
A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population
- Trial name
- NCT07135323
- Testing
- Opioid Used Disorder Risk Assessment
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Prescient Medicine Holdings, Inc.
Opioid Use Disorder
Study to Assess the Use of Tezampanel for Opioid Withdrawal Syndrome in Treatment-Seeking Patients With Opioid Use Disorder
This study is examining the use of Tezampanel (TZP) for treatment of Opioid Withdrawal Syndrome (OWS) in participants with Opioid Use Disorder (OUD).
- Trial name
- NCT06538558
- Testing
- Tezampanel
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Proniras Corporation
Narcotic Abuse, Opioid-related Disorders
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male…
- Conditions
- Narcotic Abuse, Opioid-related Disorders, Analgesia, Chronic Pain
- Trial name
- NCT01595867
- Testing
- EMBEDA - morphine sulfate/ naltrexone hydrochloride, morphine sulfate CR crushed.
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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