Clinical trials: Naltrexone
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
Lichen Planopilaris, Frontal Fibrosing Alopecia
Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
Oral naltrexone was initially FDA approved to treat opioid use disorder and alcohol dependence at doses from 50-100mg/day. At lower doses of 1-5mg/day, naltrexone has been used off-label with success in treatment of several…
- Trial name
- NCT04409041
- Testing
- Low-Dose Naltrexone
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Healthy
Endophenotype for Alcohol Misuse in Healthy Minority Populations
The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with…
- Trial name
- DEFINE (NCT00256451)
- Testing
- Naltrexone, alcohol
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
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
Binge Drinking, HIV
Better Than Study: Targeting Heavy Alcohol Use With Naltrexone Among Men Who Have Sex With Men (MSM)
This is a double-blind, placebo-controlled trial of 120 binge-drinking MSM to 12 weeks of naltrexone 50mg, to be taken in anticipation of heavy drinking.
- Trial name
- SayWhen (NCT02330419)
- Testing
- Naltrexone, Medical Management (MM) counseling for alcohol use:, Urinalysis for novel alcohol biochemical markers:
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV, AIDS
Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
Specific Aim: To conduct a randomized, placebo-controlled trial of extended release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for…
- Conditions
- HIV, AIDS, Opioid Dependence, Drug Dependence
- Trial name
- NewHope (NCT01246401)
- Testing
- Extended-Release Naltrexone
- Where
- 3 sites in United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Yale University
Opioid-use Disorder
Buprenorphine as Adjunct to Outpatient Induction Onto Vivitrol
The study will enroll 30 opioid-dependent participants into an open-label pilot outpatient study of methods to facilitate induction and stabilization onto XR-NTX.
- Trial name
- NCT03113409
- Testing
- Buprenorphine, Naltrexone, Vivitrol
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Gambling
Drug Treatment for Pathologic Gambling Disorder
This study will establish the best dose of the drug naltrexone to treat patients with Pathological Gambling Disorder (PGD) and severe urge symptoms.
- Trial name
- NCT00053677
- Testing
- Naltrexone
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Alcohol Use Disorder, Posttraumatic Stress Disorder (PTSD)
Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders
The purpose of this study is to evaluate whether the combination of prazosin and naltrexone will decrease alcohol cravings and drinking in individuals who have problems with alcohol and have used alcohol at risky levels compare…
- Trial name
- PaN (NCT02322047)
- Testing
- Prazosin, Naltrexone
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
Marijuana Smoking
Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana
In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts…
- Trial name
- NCT00743145
- Testing
- Inactive Marijuana (0% THC), Active Marijuana (5.5% THC), Active Marijuana (6.2% THC)
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
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
Marijuana Use
Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana
The purpose of this study is to determine if the subjective effects of marijuana will be decreased by low-doses (< 25 mg) of naltrexone and increased by high-doses (> 50 mg) of naltrexone.
- Trial name
- NCT00403117
- Testing
- Naltrexone 12 Mg+ Active Marijuana (3.27% THC), Naltrexone 25 Mg + Active Marijuana (3.27% THC), Naltrexone 50 Mg+ Active Marijuana (3.27% THC)
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- New York State Psychiatric Institute
Opioid-use Disorder
Pharmacokinetic Study of Vivitrol in Healthy Participants
This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.
- Trial name
- NCT04716881
- Testing
- Naltrexone 380 MG
- Where
- United States
- Volunteers
- 9 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
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
Methamphetamine, Alcohol
Intermittent Naltrexone Among Polysubstance Users
Naltrexone, a µ-opioid receptor antagonist, is a promising agent for methamphetamine-using and binge-drinking men who have sex with men (MSM).
- Trial name
- Project iN (NCT01723384)
- Testing
- Intermittent Oral Naltrexone
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
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
Opioid Dependence
Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder
This study will investigate the mechanisms of cognitive-behavioral response to medications used for relapse prevention in opioid use disorder (opioid addiction, OUD), through investigation of the neural circuits underlying key…
- Trial name
- NCT04454411
- Testing
- Brixadi, Vivitrol
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
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