Clinical trials: Naltrexone
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.
Biological Availability
Pharmacokinetics of Fentanyl Following Intravenous and Oral Routes of Administration in Healthy Volunteers
The purpose of the study is to compare the pharmacokinetics of fentanyl following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of fentanyl following oral administration.
- Trial name
- NCT00714558
- Testing
- Fentanyl citrate; Naltrexone; Naloxone
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA
Obesity, Overweight
A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects
The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.
- Trial name
- NCT00532779
- Testing
- Naltrexone SR 16 mg/Bupropion SR 360 mg /day, Naltrexone SR 32 mg/Bupropion SR 360 mg /day, Ancillary therapy
- Where
- 34 sites in United States
- Volunteers
- 1,742 people
- Sponsor
- Orexigen Therapeutics, Inc
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 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
Chronic Noncancer Pain
Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.
- Trial name
- NCT01428583
- Testing
- oxycodone HCl and naltrexone HCl extended-release capsules
- Where
- 32 sites in United States
- Volunteers
- 395 people
- Sponsor
- Pfizer
Obesity
Effect of Naltrexone Hydrochloride ER and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on Major Adverse Cardiovascular Events (MACE)
A randomized, double-blinded, placebo controlled study intended to capture cardiovascular outcomes during real-world use of naltrexone/bupropion (NB).
- Trial name
- INFORMUS (NCT06098079)
- Testing
- Naltrexone-Bupropion (NB) Combination
- Where
- 140 sites in United States
- Volunteers
- 8,600 people
- Sponsor
- Currax Pharmaceuticals
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.
Alcoholism
ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).
- Trial name
- NCT00156923
- Testing
- Medisorb naltrexone 380 mg, Medisorb naltrexone 190 mg
- Volunteers
- 108 people
- Sponsor
- Alkermes, Inc.
Opioid Dependence
A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
- Trial name
- NCT01453374
- Testing
- VIVITROL 380mg
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Alkermes, Inc.
Migraine
Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial
This two-stage clinical trial will assess a novel combination therapy for acute migraine. In Stage 1 (factorial), participants will receive the combination, each individual component, or placebo.
- Trial name
- AT-06 (NCT05685225)
- Testing
- Stage 1: Naltrexone/Acetaminophen, Stage 1: Naltrexone, Stage 1: Acetaminophen
- Where
- United States
- Sponsor
- Allodynic Therapeutics, Inc
Migraine With or Without Aura
Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine
The study consists of a screening visit, out-patient treatment of a moderate or severe migraine attack with a single dose of the study medication within 8 weeks, and End-of-Study Visit 2-7 days after dosing.
- Trial name
- ANODYNE-1 (NCT03061734)
- Testing
- Naltrexone and Acetaminophen, Naltrexone and Acetaminophen-High Dose, Naltrexone Alone (regular dose)
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Allodynic Therapeutics, Inc
Analgesia
An Open-Label Evaluation of the Independent Effects of Coadministration of a High-Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCI) 16mg
The purpose of this study was to compare the pharmacokinetic (the way a drug enters and leaves the blood and tissues over time) profile of Dilaudid OROS 16mg (Dilaudid Slow Release; hydromorphone HCL) administered under fasting…
- Trial name
- NCT00399295
- Testing
- Hydromorphone HCL 16mg; Dilaudid SR 16mg; Naltrexone (opioid antagonist) 50mg.
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA
Back Pain, Lower Back Pain
Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain
The study includes back pain of the cervical, thoracic, and the lumbar regions.
- Conditions
- Back Pain, Lower Back Pain, Cervical Pain
- Trial name
- NCT01415895
- Testing
- Naltrexone and Clonidine Combination
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Annette C. Toledano MD
Alcoholism
ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed.
- Trial name
- NCT01218958
- Testing
- Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg
- Volunteers
- 624 people
- Sponsor
- Alkermes, Inc.
Obesity, Overweight
Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
The purpose of this study is to determine the effects of NB relative to placebo on major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke in overweight and…
- Trial name
- NCT01601704
- Testing
- NB32, PBO, Weight Management Program
- Where
- 224 sites in United States
- Volunteers
- 8,910 people
- Sponsor
- Orexigen Therapeutics, Inc
Moderate-severe Pain
Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain
Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of oxycodone hydrochloride with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
- Trial name
- NCT02680847
- Testing
- ALO-02
- Where
- 16 sites in United States
- Volunteers
- 32 people
- Sponsor
- Pfizer
Opioid-Related Disorders
Bioequivalency Study of Buprenorphine Hydrochloride 8 mg Tablet Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Buprenorphine HCl 8 mg tablet under fasted conditions.
- Trial name
- NCT00992095
- Testing
- buprenorphine hydrochloride
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Healthy
A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers
To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.
- Trial name
- NCT01677065
- Testing
- Oxycodone controlled-release test formulation, Immediate-release reference drug
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Pfizer
Depression
A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of major depression in overweight or obese subjects.
- Trial name
- NCT00624858
- Testing
- naltrexone SR 32 mg/ bupropion SR 360 mg daily
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Orexigen Therapeutics, Inc