Clinical trials: Opiates
Opioid Related Disorders, Opiate Addiction
Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could…
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02920775
- Testing
- Non-interventional study - retrospective database review
- Volunteers
- 360,000 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid Overdose
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into…
- Trial name
- NCT06719986
- Testing
- Nalmefene HCl injection, Naloxone HCl intranasal
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Opioid-use Disorder, Opioid-related Disorders
An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery
The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery from opioid use disorder (OUD) over a 24-month period following exit from a Phase III clinical program for a buprenorphine…
- Trial name
- RECOVER® (NCT03604861)
- Testing
- Not applicable - no defined intervention
- Where
- 35 sites in United States
- Volunteers
- 534 people
- Sponsor
- Indivior Inc.
Healthy Volunteer Study
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
- Trial name
- NCT07314346
- Testing
- Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Opiate-Related Disorders, Opiate Substitution Treatment
A Chatbot To Support Substance Use Recovery
The goal of this clinical trial is to learn if/how an AI chatbot can support patients who in recovery for substance use, specifically those who are receiving medication for opioid use disorder.
- Trial name
- NCT06845878
- Testing
- chatbot
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Dimagi Inc.
Opioid Overdose
Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens
This study is to compare the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given as a single dose intranasally (IN;into the nose), as a single dose in each nostril and…
- Trial name
- NCT05219669
- Testing
- Nalmefene Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Opiant Pharmaceuticals Inc
Opiate Dependent
Morphine Slow-release Capsules in Substitution Therapy
To compare the effectiveness of slow release oral morphine treatment in patients that previously have been treated with methadone
- Trial name
- NCT01079117
- Testing
- Sevre-Long™, Slow release oral morphine, Methadone
- Where
- Switzerland
- Volunteers
- 276 people
- Sponsor
- Mundipharma Medical Company
Substance Withdrawal Syndrome, Opiate Addiction
Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction
The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.
- Conditions
- Substance Withdrawal Syndrome, Opiate Addiction, Opiate Dependence
- Trial name
- NCT02801357
- Testing
- lofexidine administration in subjects seeking buprenorphine dose reduction
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
HIV Infections
Safety Study of Once a Day ART and Opiate Substitute.
This study looks at HIV-infected subjects who are on methadone treatment and medicines for HIV.
- Trial name
- 3OD (NCT00324688)
- Testing
- Viread
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Gilead Sciences
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto…
- Conditions
- Opiate Dependence, Drug Dependence, Substance Dependence
- Trial name
- NCT00604188
- Testing
- Suboxone (SCH 000484), Subutex (SCH 028444)
- Volunteers
- 188 people
- Sponsor
- Merck Sharp & Dohme LLC
Opiate Dependence
Multicentre Trial of Suboxone in Opiate-dependent Subjects in Taiwan
To determine whether Suboxone can be effectively used to treat Taiwanese ethnic subjects with opiate dependence.
- Trial name
- NCT00901875
- Testing
- Buprenorphine + naloxone (Suboxone)
- Where
- 8 sites in Taiwan
- Volunteers
- 127 people
- Sponsor
- Indivior Inc.
Opioid Use Disorder
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
- Trial name
- NCT02537574
- Testing
- NTX/BUP, NTX/PBO-B, PBO-N/PBO-B
- Where
- 20 sites in United States
- Volunteers
- 380 people
- Sponsor
- Alkermes, Inc.
Chronic Pain, Pain
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
This Phase 2 study will evaluate whether multiple doses of cebranopadol suppress opioid withdrawal signs and symptoms compared with placebo in adults with chronic pain who are physically dependent on prescribed opioids.
- Conditions
- Chronic Pain, Pain, Opioid Withdrawal (Disorder), Opioid Use Disorder
- Trial name
- NCT07874620
- Testing
- Cebranopadol
- Where
- 2 sites in United States
- Volunteers
- 45 people
- Sponsor
- Adneuris Therapeutics, Inc.
Healthy Subjects
Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study.
To assess the combined effects of fosamprenavir 700mg BID + ritonavir 100mg BID + standardized dose of methadone, on plasma total and unbound methadone enantiomer pharmacokinetics (PK), opiate pharmacodynamic (PD) measures, and…
- Trial name
- NCT00481182
- Testing
- fosamprenavir + ritonavir + methadone
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Short Bowel Syndrome, Short Gut Syndrome
A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals
MP-101 will be evaluated in this study to see if it is safe, tolerable, and can help people with Short Bowel Syndrome. This study will also find out if taking MP-101 can improve the symptoms of Short Bowel Syndrome and reduce the…
- Conditions
- Short Bowel Syndrome, Short Gut Syndrome, SBS, Short Bowel
- Trial name
- NCT02242656
- Testing
- Opium Tincture USP Deodorized
- Where
- 5 sites in United States
- Sponsor
- Marathon Pharmaceuticals, LLC
Opiate Dependence
ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid…
- Trial name
- NCT00678418
- Testing
- VIVITROL® 380 mg
- Where
- Russia
- Volunteers
- 250 people
- Sponsor
- Alkermes, Inc.
Opiate Dependence
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
- Trial name
- NCT00834080
- Testing
- Medisorb naltrexone 380 mg
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Alkermes, Inc.
Alcoholism, Opiate Dependence
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection.
- Trial name
- NCT00156936
- Testing
- Medisorb naltrexone 380 mg, Oral naltrexone to Medisorb naltrexone 380 mg
- Volunteers
- 108 people
- Sponsor
- Alkermes, Inc.
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