Clinical trials: Naltrexone
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.
Cocaine-Related Disorders, Heroin Dependence
Employment-based Reinforcement of Naltrexone Ingestion and Abstinence
A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone ingestion and abstinence in unemployed opiate-dependent injection drug users.
- Conditions
- Cocaine-Related Disorders, Heroin Dependence, Opioid-Related Disorders, Substance Abuse, Intravenous
- Trial name
- NCT00149669
- Testing
- employment-based reinforcement
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Johns Hopkins University
Cannabis Dependence
Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence
This is an 8 week, outpatient research study testing the use of long-acting naltrexone (Vivitrol) as a treatment for marijuana dependence.
- Trial name
- NCT02088177
- Testing
- Long-acting injectable naltrexone
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- New York State Psychiatric Institute
Fibromyalgia, Persian Gulf Syndrome
Effects of Low Dose Naltrexone in Fibromyalgia
Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural pain-reducing systems.
- Trial name
- NCT00568555
- Testing
- Low Dose Naltrexone
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Stanford University
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
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
HIV Infection
Clinical Trial to Reduce Drinking in Women With HIV
The primary objective of this study is to evaluate whether an intervention that involves the medication naltrexone, will reduce drinking and improve health outcomes in women with HIV infection and hazardous drinking.
- Trial name
- WHATIF (NCT01625091)
- Testing
- Naltrexone
- Where
- 2 sites in United States
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- University of Florida
Heroin Dependence, Opioid-Related Disorders
Addiction Treatment in Russia: Oral vs. Naltrexone Implant
Heroin addiction is a growing problem in Russia; individuals who enter heroin addiction treatment often relapse. Therefore, effective heroin addiction treatments are necessary to prevent relapse.
- Trial name
- NCT00218426
- Testing
- naltrexone implant, oral naltrexone
- Where
- 2 sites in United States, Russia
- Volunteers
- 306 people
- Sponsor
- University of Pennsylvania
Fibromyalgia
Low Dose Naltrexone (LDN) Immune Monitoring
We have found that low dose naltrexone (LDN) can substantially reduce pain associated with fibromyalgia syndrome. We believe LDN may work via novel anti-inflammatory channels.
- Trial name
- LDN-IM (NCT02107014)
- Testing
- Low Dose Naltrexone
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Alabama at Birmingham
Osteoarthritis, Arthritis, Rheumatoid
Low Dose Naltrexone for Chronic Pain From Arthritis
Over 100 million Americans report chronic pain. Veterans are disproportionately affected for multiple reasons, including injuries and post-traumatic stress disorder.
- Conditions
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic
- Trial name
- LDN-VA (NCT03008590)
- Testing
- Naltrexone
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- VA Office of Research and Development
Heroin Dependence
Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol.
- Trial name
- NCT03711318
- Testing
- Buprenorphine/naloxone
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Schizophrenia, Diabetes Mellitus, Type 2
Naltrexone-Bupropion Versus Placebo-Bupropion for Weight Loss in Schizophrenia
The purpose of this study is to determine the efficacy of combining open-label extended release bupropion (flexible dosing up to 450mg target) and naltrexone (37.5mg) versus Bupropion and placebo along with a daily 500 calorie…
- Conditions
- Schizophrenia, Diabetes Mellitus, Type 2, Obesity
- Trial name
- NBC (NCT03132571)
- Testing
- Naltrexone, Bupropion
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Yale University
Prescription Opiate/Medication Dependence
CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery
The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers predicting drug use during and after treatment in 72 subjects addicted to prescription opioids/medications.
- Trial name
- fMRI CURE (NCT01587196)
- Testing
- Vivitrol
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- University of Pennsylvania
Cocaine Dependence, Alcohol Dependence
VIVITROL as a Treatment for Cocaine and Alcohol Dependence
To evaluate the efficacy of VIVITROL (naltrexone for extended-release injectable suspension) for the treatment of co-occurring cocaine and alcohol dependence
- Trial name
- NCT00777062
- Testing
- VIVITROL (Naltrexone extended-release injectable suspension)
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- University of Pennsylvania
Alcohol Dependence
Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence
The over-arching goal of the proposed project is to understand the impact of medication adherence upon engagement in behavioral treatment for alcohol use disorders.
- Trial name
- NCT01856712
- Testing
- Naltrexone
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Wisconsin, Madison
Methamphetamine Use Disorder
Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder.
- Trial name
- ADAPT-2 (NCT03078075)
- Testing
- Naltrexone: Vivitrol®, Bupropion: Wellbutrin XL®
- Where
- 8 sites in United States
- Volunteers
- 403 people
- Sponsor
- University of Texas Southwestern Medical Center
Alcohol Dependence
An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all…
- Trial name
- NALAPZ (NCT00667875)
- Testing
- Naltrexone, Naltrexone + Aripiprazole
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Medical University of South Carolina
Opiate Dependence
Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol).
- Trial name
- BUP/NXT-VIVI (NCT01690546)
- Testing
- very low dose naltrexone, extended release naltrexone, buprenorphine/naloxone
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Paolo Mannelli
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
Type 1 Diabetes, Hypoglycemia Unawareness
Naltrexone and Hypoglycemia in Type 1 Diabetes
Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food.
- Trial name
- Naltrexone (NCT01053078)
- Testing
- Naltrexone
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- University of Minnesota