Clinical trials: Naltrexone
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
Cocaine-related Disorders
Buprenorphine Naltrexone-P1 A-Cocaine
The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone.
- Trial name
- NCT00733720
- Testing
- Suboxone
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Opiate Addiction
Long-acting Naltrexone for Pre-release Prisoners
This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication.Following initial screening, informed…
- Trial name
- NCT02867124
- Testing
- XR-NTX, place of residence, opioid treatment program
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Friends Research Institute, Inc.
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
Smoking, Smoking Cessation
Efficacy of Naltrexone in Women's Smoking Cessation
The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs.
- Trial name
- NCT00271024
- Testing
- Naltrexone (drug)
- Where
- United States
- Volunteers
- 333 people, healthy volunteers welcome
- Sponsor
- University of Chicago
Opioid-Related Disorders, Opioid Withdrawal
Comparison of Three Opioid Detoxification Treatment Regimens
Despite an increased focus on treating opioid use disorder there are relatively few studies that compare the length of time required for detoxification with medications other than buprenorphine.
- Trial name
- NCT03678792
- Testing
- Buprenorphine/naloxone, Morphine, Tramadol
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Alcohol Use Disorder
In Hospital IM Naltrexone: A Pilot Study
This is a study in-hospital administration of injectable naltrexone vs. oral naltrexone. This is a pilot study to assess provider's and patient's acceptability to be randomized to oral vs.
- Trial name
- IM-NTX (NCT05087771)
- Testing
- injectable naltrexone, oral naltrexone
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
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)
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
Opioid-use Disorder
Evaluation of Intranasal Naltrexone and Naloxone
This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.
- Trial name
- NCT03851731
- Testing
- Naltrexone, Naloxone, Naltrexol
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Healthy, Attention Deficit Hyperactivity Disorder
Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS))
The goal of this research is to understand the functioning of 'regulatory circuits' in the brain. We are also interested in how the medications methylphenidate and naltrexone affect these regulatory circuits.
- Trial name
- NMAS (NCT01993108)
- Testing
- Methylphenidate, Naltrexone
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Opiod Use Disorder
Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160)
This is an Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Naltrexone HCL to DLP-160 (Naltrexone implant) to Intramuscular Vivitrol®
- Trial name
- NCT05304364
- Testing
- Combination Product: Naltrexone
- Where
- Australia
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Delpor, Inc.
Pain
Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10 mg Tablets under fasting conditions
- Trial name
- NCT01210638
- Testing
- Oxymorphone
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Methamphetamine Dependence
Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study
The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.
- Trial name
- NCT01359930
- Testing
- Naltrexone and Bupropion SR
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
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
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
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
Opioid Use Disorder
iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers
This Phase 1b clinical study is evaluating iSTEP-N, an investigational extended-release implant containing naltrexone, a medication used to block the effects of opioids.
- Trial name
- iSTEP-N (NCT07064564)
- Testing
- Naltrexone implant, 14.4 grams, Naltrexone implant, 9.6 grams, Extended-release naltrexone injection, 380 mg
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Akyso Therapeutics, LLC
Breast Cancer, Obesity
Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients
Obesity among breast cancer survivors is known to be associated with recurrence and other co-morbidities. However, there have been no studies on weight reduction program combining diet and anti-obesity drug for obese breast…
- Conditions
- Breast Cancer, Obesity, Overweight
- Trial name
- NCT03581630
- Testing
- naltrexone/bupropion, Mediterranean Diet
- Where
- South Korea
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Gangnam Severance Hospital
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