Clinical trials: Naltrexone
Healthy Adults
An Adherence Tool to Manage Narcotic -Addicted HIV Patients
The purpose of this study is to develop a cost-effective breath-based medication adherence monitoring system that can monitor whether recovering opiate addicts actually take a specific treatment medication called naltrexone.
- Trial name
- NCT02194764
- Testing
- Naltrexone and 2-butanol, 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Xhale Assurance
Migraine With or Without Aura
The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination
The Preventive Treatment of Migraine with Low-Dose Naltrexone and Acetaminophen Combination: A Small, Randomized, Double-Blind, and Placebo-Controlled Clinical Trial with an Open-Label Extension for None-Responders
- Trial name
- NCT03194555
- Testing
- Low-Dose Naltrexone and Acetaminophen Combination
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Allodynic Therapeutics, Inc
Weight Regain Post Bariatric Surgery
Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Participants Post Bariatric Surgery
The purpose of this study is to determine the effect of naltrexone hydrochloride(HCL) and bupropion hydrochloride extended release combination (NB) compared with placebo on weight loss in obese participants post bariatric surgery.
- Trial name
- NCT02616315
- Testing
- Naltrexone HCl/Bupropion HCl
- Where
- 2 sites in United States
- Sponsor
- Takeda
Alcohol Use Disorder (AUD)
Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. The study plans to enroll 240 adult patients with Alcohol Use Disorder (AUD).
- Trial name
- AUD (NCT07433413)
- Testing
- Naltrexone
- Volunteers
- 240 people
- Sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.
Healthy
Pharmacokinetics of SP-104
This open-label, 3-period, 3-treatment, randomized study will characterize the pharmacokinetics and safety and tolerability of SP-104 under fasting and fed conditions as compared to the pharmacokinetics of Naltrexone…
- Trial name
- NCT05002946
- Testing
- SP-104, Naltrexone Hydrochloride 50Mg Oral Tablet
- Where
- New Zealand
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Scilex Pharmaceuticals, Inc.
Chronic Pain
A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant
The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.
- Trial name
- NCT00650182
- Testing
- fentanyl; naltrexone
- Volunteers
- 406 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA
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.
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.
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.
Opioid Use Disorder
The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers
This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner.
- Trial name
- NCT03810495
- Testing
- naltrexone implant
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Go Medical Industries Pty Ltd
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
Osteoarthritis, Chronic Pain
A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.
- Trial name
- NCT00420992
- Testing
- ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
- Where
- 81 sites in United States
- Volunteers
- 547 people
- Sponsor
- Pfizer
Healthy
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
- Trial name
- NCT01775189
- Testing
- crushed ALO-02 30 mg/3.6 mg, crushed oxycodone IR 30 mg
- Where
- Canada
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pain
A Study to Evaluate Safety and Efficacy Following Dosing of Oxycodone/Naltrexone for Treatment of Adults With Pain Following Bunionectomy Surgery
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study to evaluate the efficacy and safety of the administration of multiple doses of Oxycodone Hydrochloride plus Naltrexone…
- Trial name
- NCT02401750
- Testing
- Oxycodone Naltrexone (a), Oxycodone Naltrexone (b)
- Where
- 5 sites in United States
- Volunteers
- 163 people
- Sponsor
- Elite Laboratories, 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 Use Disorder, Opioid Withdrawal
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use…
- Conditions
- Opioid Use Disorder, Opioid Withdrawal, Substance Use Disorders
- Trial name
- IBO-CARE (NCT07871877)
- Testing
- Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg, My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Clive Michelsen
Healthy Subjects
Study to Evaluate the Effect of Naltrexone and Bupropion Combination on the Pharmacokinetics of Metformin in Healthy Participants
The purpose of this study is to determine the effect of multiple oral doses of naltrexone/bupropion on the pharmacokinetics (PK) of a single oral dose of metformin.
- Trial name
- NCT02745912
- Testing
- Naltrexone/Bupropion, Metformin
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Orexigen Therapeutics, Inc
Healthy
Bioequivalence Study Comparing Naltrexone SR/Bupropion SR Trilayer Tablets From Two Manufacturers
This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination trilayer tablets prepared at two different…
- Trial name
- NCT02259179
- Testing
- Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets), Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Orexigen Therapeutics, Inc
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
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.