Clinical trials: Naltrexone
Pain
Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain
Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
- Trial name
- NCT00415597
- Testing
- ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
- Where
- 58 sites in United States
- Volunteers
- 467 people
- Sponsor
- Pfizer
Chronic Pain, Low Back Pain
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
- Conditions
- Chronic Pain, Low Back Pain, Analgesia
- Trial name
- NCT01571362
- Testing
- ALO-02
- Where
- 52 sites in United States
- Volunteers
- 410 people
- Sponsor
- Pfizer
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.
ECG Effects
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) at Doses up to 80 Micrograms/Hour (mcg/hr) and Naltrexone on Electrocardiogram (ECG) Intervals in Healthy Volunteers
The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.
- Trial name
- NCT01999114
- Testing
- Buprenorphine transdermal patch, Naltrexone tablet, Moxifloxacin tablet
- Where
- United States
- Volunteers
- 328 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Chronic Pain
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
- Trial name
- NCT01100437
- Testing
- EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush, EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Pfizer
Obesity, Overweight
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program…
- Trial name
- NCT00456521
- Testing
- Naltrexone SR 32 mg/ bupropion SR 360 mg/ day, Intensive group lifestyle modification counseling
- Where
- 9 sites in United States
- Volunteers
- 793 people
- Sponsor
- Orexigen Therapeutics, Inc
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.
Alcohol Dependence
ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults
This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further…
- Trial name
- NCT00511836
- Testing
- VIVITROL 380 mg
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Alkermes, Inc.
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.
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
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
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.
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
Depression
The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
The purpose of this clinical trial is to determine the safety and efficacy of scopolamine utilized in conjunction with naltrexone for the treatment of major depression.
- Trial name
- NCT03386448
- Testing
- Scopolamine and naltrexone
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- The Taub Group
Obesity, Overweight
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects
The purpose of this study is to determine whether the combination of naltrexone SR and bupropion SR is safe and effective in the treatment of obesity.
- Trial name
- NCT00567255
- Testing
- Naltrexone SR 32 mg/bupropion SR 360 mg/day, Ancillary therapy
- Where
- 36 sites in United States
- Volunteers
- 1,496 people
- Sponsor
- Orexigen Therapeutics, Inc
Obesity, Cardiovascular Diseases
Naltrexone/Bupropion Cardiovascular Outcomes Study
The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo and rule out excess risk of major adverse…
- Trial name
- NCT02638129
- Testing
- Naltrexone HCl/Bupropion HCl ER
- Where
- 139 sites in United States
- Volunteers
- 67 people
- Sponsor
- Orexigen Therapeutics, Inc