Clinical trials: Opioid-related Disorders
Opiate Dependence
ALK21-004: Single-dose Opiate Challenge of Medisorb® Naltrexone (VIVITROL®) in Adults Who Use Opioids
This was a Phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults to assess the presence, duration, and degree of opiate blockade as well as the safety and tolerability of Medisorb® naltrexone…
- Trial name
- NCT01218984
- Testing
- Medisorb naltrexone 75 mg, Medisorb naltrexone 150 mg, Medisorb naltrexone 300 mg
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Opioid-Related Disorders, Opiate Dependence
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only.
- Trial name
- NCT01848054
- Testing
- Buprenorphine/naloxone sublingual tablets, Buprenorphine
- Where
- 14 sites in United States
- Volunteers
- 313 people
- Sponsor
- Orexo AB
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.
Alcoholism
To Evaluate the Influence of the A118G Polymorphism in the mu Opioid Receptor Gene (OPRM1) on Effects of GSK1521498 and Naltrexone on Physiological and Behavioural Markers of Brain Function in Healthy Social Drinkers
A total of at least 48 healthy subjects with a history of social drinking will be recruited into this single-centre, randomized, double-blind, cross-over study.
- Trial name
- NCT01738867
- Testing
- GSK1521498, Naltrexone (NTX)
- Where
- United Kingdom
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Opioid-induced Constipation
Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
This qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives.
- Trial name
- NCT01645371
- Volunteers
- 79 people
- Sponsor
- AstraZeneca
Opioid-Induced Constipation
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment of opioid-induced constipation (OIC) in patients with cancer-related pain, including those patients that have inadequate response to…
- Trial name
- NCT01384292
- Testing
- NKTR-118
- Where
- 140 sites in United States, Australia and 12 more
- Volunteers
- 14 people
- Sponsor
- AstraZeneca
Opioid Use Disorder
Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults
The purpose of this study is to evaluate the safety and blood levels of a medicine, naltrexone, contained within an implant in healthy volunteers age 18 to 65 years.
- Trial name
- NCT06216132
- Testing
- BIOPIN-6 Active Implant with Naltrexone
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Akyso Therapeutics, LLC
Opioid-Induced Bowel Dysfunction
Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).
- Trial name
- OPAL (NCT00597428)
- Testing
- Lubiprostone
- Where
- 114 sites in United States, Canada
- Volunteers
- 437 people
- Sponsor
- Sucampo Pharma Americas, LLC
Opioid Use Disorder
Remotely Observed Methadone Evaluation
Opioid addiction, which affects 16 million individuals worldwide, can be treated using methadone, a proven and effective opioid medication for treating OUD that extends retention in care, reduces mortality, and inhibits illicit…
- Trial name
- ROME (NCT06200740)
- Testing
- Sonara
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Sonara Health
Opioid Dependence, Alcohol Dependence
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
- Conditions
- Opioid Dependence, Alcohol Dependence, Multiple Sclerosis
- Trial name
- NCT05620940
- Testing
- Vivitrol Injectable Product, IVL3004, IVL4002
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Inventage Lab., Inc.
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.
Constipation
Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
- Trial name
- NCT00365820
- Testing
- Tegaserod
- Where
- 59 sites in United States
- Volunteers
- 670 people
- Sponsor
- Novartis
Opioid Misuse
Decreasing Opioid Misuse and Habit-forming Behaviors Following Prescription in Patients Undergoing Cesarean Section
Background: Cesarean delivery is one of the most common obstetric procedures experienced among women who are pregnant.1 Women with Cesarean deliveries have a higher rate of peripartum opioid prescriptions and persistent opioid…
- Trial name
- NCT05461196
- Testing
- CPMRx
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Jessica Morgan
Opioid-induced Constipation
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain.
- Trial name
- NCT00399659
- Testing
- Tegaserod
- Where
- 57 sites in United States
- Volunteers
- 360 people
- Sponsor
- Novartis
Opioid-induced Constipation
Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.
- Trial name
- NCT00640146
- Testing
- Methylnaltrexone bromide
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Bausch Health Americas, Inc.
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.
Opiate Withdrawal Syndrome
A Study of Oral Ibogaine in Opioid Withdrawal
Study DMX-IB 201 is a Phase 1/2a study of ibogaine consisting of an initial single ascending dose escalation stage to determine the maximum tolerated dose (MTD) or treat-to-target dose (TTD) in healthy volunteers, followed by a…
- Trial name
- NCT05029401
- Testing
- DMX-1002
- Where
- 2 sites in United Kingdom
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- atai Therapeutics, Inc.
Target Drug-related Adverse Events
Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens
The purpose of this study is to determine whether the addition of selective pharmacogenomic (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced by a reduction in Target Drug-related…
- Trial name
- SPHERE (NCT02625155)
- Testing
- Urine diagnostic testing as SOC, drug regimen changes per SOC, Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results
- Where
- United States
- Volunteers
- 14,000 people, healthy volunteers welcome
- Sponsor
- InSource Diagnostics
Opiate-related Disorders, Opiate Dependence
Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)
This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®.
- Conditions
- Opiate-related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00684073
- Testing
- buprenorphine, buprenorphine/naloxone
- Volunteers
- 60 people
- Sponsor
- Indivior Inc.
Opioid-use Disorder, Opioid Withdrawal
Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
Clinical performance data for transcutaneous auricular neurostimulation (tAN) as a method to aid in the reduction of symptoms associated with opioid withdrawal in order to support clinical substantial equivalence to a predicate…
- Trial name
- NCT04075214
- Testing
- transcutaneous auricular neurostimulation (tAN)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Spark Biomedical, Inc.