Clinical trials: Naltrexone
Healthy
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.
- Trial name
- NCT01746901
- Testing
- intact ALO-02 60 mg/7.2 mg, crushed ALO-02 60 mg/7.2 mg, crushed oxycodone IR 60 mg
- Where
- Canada
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Pfizer
Withdrawal Symptoms
A Study to Evaluate Withdrawal Effects Following Dosing of Oxycodone/Naltrexone in Methadone-Maintained Subjects
This single-center study is a randomized, double-blind, active-controlled, multiple-dose, parallel group study to evaluate the potential withdrawal effects, safety and tolerability, and pharmacokinetic and pharmacodynamic effects…
- Trial name
- NCT02391571
- Testing
- Oxycodone/Naltrexone Capsules, Oxycodone
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Elite Laboratories, Inc
Obsessive-Compulsive Disorder
Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder
The purpose of this study is to determine if the combination of naltrexone SR and fluoxetine is more effective in treating the symptoms of obsessive-compulsive disorder (OCD)than either fluoxetine alone or naltrexone SR alone.
- Trial name
- NCT00758966
- Testing
- Fluoxetine 60 mg, Naltrexone 32 mg and fluoxetine 60 mg, Naltrexone SR 32 mg
- Where
- 11 sites in United States
- Volunteers
- 8 people
- Sponsor
- Orexigen Therapeutics, Inc
Alcoholism
ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as…
- Trial name
- NCT01218997
- Testing
- Medisorb naltrexone 380 mg, Oral naltrexone 50 mg
- Volunteers
- 436 people
- Sponsor
- Alkermes, Inc.
Heart Repolarization
Study to Evaluate the Effect of Naltrexone and Bupropion Extended-Release Combination on Cardiac Repolarization in Healthy Participants
The purpose of this study is to evaluate the potential effect of naltrexone and bupropion extended-release combination on cardiac repolarization in healthy participants.
- Trial name
- NCT02735603
- Testing
- Naltrexone HCl/bupropion HCl, Moxifloxacin
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Orexigen Therapeutics, Inc
Healthy
Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects
A Phase 1, open-label, single-arm study with two single doses of lofexidine and multiple doses of naltrexone in healthy adult subjects to determine the effect of naltrexone on the single dose pharmacokinetics of the oral…
- Trial name
- NCT02446002
- Testing
- Lofexidine + Naltrexone
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Healthy
Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation
The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled…
- Trial name
- NCT01677039
- Testing
- Test formulation administered with water, Test formulation administered with 20% ethanol, Test formulation administered with 40% ethanol
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
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
Healthy Volunteers
Study to Evaluate the Safety of SP-104
Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone hydrochloride immediate release.
- Trial name
- NCT04958876
- Testing
- SP-104, Naltrexone immediate release oral capsules
- Where
- 2 sites in New Zealand
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Scilex Pharmaceuticals, 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.
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
Naltrexone, Methylphenidate Abuse
Study for Naltrexone on the Abuse Potential of Methylphenidate
The current abuse liability study aims to assess the potential for co-administration of naltrexone (NTX) to reduce the abuse potential of methylphenidate (MPH).
- Trial name
- NCT03769064
- Testing
- Methylphenidate 60 mg, Treatment Phase Sequence 4213, Treatment Phase Sequence 2134
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Avekshan LLC
Obesity, Overweight
Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects
The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its…
- Trial name
- NCT01764386
- Testing
- NB, CLI, Usual Care
- Where
- 15 sites in United States
- Volunteers
- 242 people
- Sponsor
- Orexigen 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
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.
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
ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.
- Trial name
- NCT00501631
- Testing
- VIVITROL 380 mg
- Volunteers
- 300 people
- Sponsor
- Alkermes, Inc.