Naltrexone Hydrochloride

Pruritus, Caloric Restriction, Obesity + 8 more
Treatment
7 FDA approvals
7 Active Studies for Naltrexone Hydrochloride

What is Naltrexone Hydrochloride

NaltrexoneThe Generic name of this drug
Treatment SummaryNaltrexone is a medication derived from noroxymorphone that works as an opioid antagonist. It is a stronger and longer-lasting version of naloxone and has been used to treat heroin addiction. The FDA has also approved naltrexone for the treatment of alcohol dependence.
Naltrexone Hydrochlorideis the brand name
image of different drug pills on a surface
Naltrexone Hydrochloride Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Naltrexone Hydrochloride
Naltrexone
1998
59

Approved as Treatment by the FDA

Naltrexone, otherwise known as Naltrexone Hydrochloride, is approved by the FDA for 7 uses including Opioid-Related Disorders and Opioid Dependence .
Opioid-Related Disorders
Helps manage Opioid Dependence
Opioid Dependence
Helps manage Opioid Dependence
Alcohol Dependency
Helps manage Alcohol Dependency
Therapeutic procedure
Used to treat inadequate alternative treatment options in combination with Morphine
Alcoholism
Helps manage Alcohol Dependency
Pain
Used to treat Severe Pain in combination with Morphine
Opiate Substitution Treatment
Used to treat requiring long-term opioid treatment in combination with Morphine

Effectiveness

How Naltrexone Hydrochloride Affects PatientsNaltrexone is a drug that works to prevent the effects of opioids. It has no opioid properties of its own and is often used to treat alcohol dependence. When taken with other opioids, it blocks the physical effects of these drugs and can help to reduce addiction. In people already addicted to opioids, taking naltrexone can cause withdrawal symptoms.
How Naltrexone Hydrochloride works in the bodyNaltrexone blocks the effects of opioids in the brain. It achieves this by binding to opioid receptors, preventing any opiates from having an effect. This blocks the calming, pleasurable effects of opioids, as well as the respiratory depression. It also reduces cravings. The drug's major metabolite, 6-β-naltrexol, is also an opioid antagonist, helping to make naltrexone even more effective.

When to interrupt dosage

The measurement of Naltrexone Hydrochloride depends on the determined disease, including Opioid Dependence, low-calorie diet and BMI >27 kg/m2. The quantity of dosage varies in accordance to the method of administration specified in the table beneath.
Condition
Dosage
Administration
Opioid-Related Disorders
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular
Comorbidity
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular
Chronic Weight Management therapy
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular
Caloric Restriction
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular
Pruritus
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular
Increased physical activity levels
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular
Obesity
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular
Pain
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular
Alcoholism
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular
Opiate Substitution Treatment
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular
Therapeutic procedure
, 50.0 mg, 0.8 mg, 1.2 mg, 2.0 mg, 4.0 mg, 2.4 mg, 3.2 mg, 8.0 mg, 4.8 mg, 3.6 mg, 7.2 mg, 9.6 mg, 380.0 mg, 200.0 mg, 380.0 mg/mL, 90.0 mg
, Oral, Tablet, film coated, Tablet, film coated - Oral, Capsule, extended release, Capsule, extended release - Oral, Tablet, film coated, extended release, Tablet, film coated, extended release - Oral, Kit, Tablet, Tablet - Oral, Tablet, extended release, Tablet, extended release - Oral, Subcutaneous, Implant, Implant - Subcutaneous, Intramuscular, Kit - Intramuscular

Warnings

Naltrexone Hydrochloride Contraindications
Condition
Risk Level
Notes
Pulse Frequency
Do Not Combine
Pulse Frequency
Do Not Combine
Withdrawal syndrome
Do Not Combine
Adrenal gland hypofunction
Do Not Combine
There are 20 known major drug interactions with Naltrexone Hydrochloride.
Common Naltrexone Hydrochloride Drug Interactions
Drug Name
Risk Level
Description
Eluxadoline
Major
The risk or severity of constipation can be increased when Naltrexone is combined with Eluxadoline.
Methylene blue
Major
Naltrexone may increase the serotonergic activities of Methylene blue.
Methylnaltrexone
Major
Naltrexone may increase the opioid antagonism activities of Methylnaltrexone.
Mirtazapine
Major
Naltrexone may increase the serotonergic activities of Mirtazapine.
Naloxegol
Major
Naltrexone may increase the opioid antagonism activities of Naloxegol.
Naltrexone Hydrochloride Toxicity & Overdose RiskIn mice, rats, and guinea pigs, the toxic dose of naltrexone is between 1,100 and 1,550 mg/kg. Taking large doses of naltrexone (over 1,000 mg/kg) can lead to excessive salivation, decreased energy, tremors, and seizures.
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Naltrexone Hydrochloride Novel Uses: Which Conditions Have a Clinical Trial Featuring Naltrexone Hydrochloride?

30 active studies are testing the ability of Naltrexone Hydrochloride to attenuate reduced-calorie diet, Pruritus and increased physical activity in treating certain conditions.
Condition
Clinical Trials
Trial Phases
Caloric Restriction
0 Actively Recruiting
Pain
0 Actively Recruiting
Pruritus
0 Actively Recruiting
Comorbidity
0 Actively Recruiting
Chronic Weight Management therapy
0 Actively Recruiting
Increased physical activity levels
0 Actively Recruiting
Opioid-Related Disorders
0 Actively Recruiting
Opiate Substitution Treatment
0 Actively Recruiting
Obesity
0 Actively Recruiting
Therapeutic procedure
0 Actively Recruiting
Alcoholism
7 Actively Recruiting
Not Applicable, Phase 2, Phase 3

Naltrexone Hydrochloride Reviews: What are patients saying about Naltrexone Hydrochloride?

5Patient Review
9/18/2022
Naltrexone Hydrochloride for Habit of Drinking Too Much Alcohol
I've been pleasantly surprised by this medication. I'm a heavy drinker and it's helped me cut down to less than one drink per day. I didn't experience any major side effects, just felt a bit tired the first day. Fingers crossed it keeps working like this!
5Patient Review
8/30/2021
Naltrexone Hydrochloride for Habit of Drinking Too Much Alcohol
I was really struggling with my drinking before I found this treatment. It worked great from the first pill and I haven't had a drink or any urge to drink for 3 days now.
5Patient Review
4/9/2022
Naltrexone Hydrochloride for Habit of Drinking Too Much Alcohol
I'm glad I found this sooner rather than later! It worked within 15 minutes.
2Patient Review
10/25/2021
Naltrexone Hydrochloride for Habit of Drinking Too Much Alcohol
I'm on day one of the 50mg dosage, and I don't know if I can continue. The nausea is really bad, and I feel shaky and sweaty all the time. It's hard to breathe, and I can't sleep or get up and move around. This isn't like withdrawals from drinking--I haven't had a drink in over two weeks. I'm not sure if this medication is right for me.
1.7Patient Review
10/24/2022
Naltrexone Hydrochloride for Habit of Drinking Too Much Alcohol
The website for this medication does not mention any of the harmful side effects that I experienced, like the full body rash that took a month to get rid of. I had to go to the doctor and get skin grafts just to figure out what it was from, and it turns out it was from this medication. Do not recommend.
1Patient Review
3/21/2022
Naltrexone Hydrochloride for Habit of Drinking Too Much Alcohol
I took the medication as directed, but I woke up feeling awful just a few hours later. I was vomiting and shaking uncontrollably, and had to leave work early as a result. This medication has caused me nothing but problems, and I would not recommend it to anyone.
1Patient Review
7/10/2022
Naltrexone Hydrochloride for Prevention of Opiate Drug Abuse
I was given this drug to help me wean off of opiates, but my first dose made me so sick that I would rather go through withdrawal on my own than use this again.
1Patient Review
9/16/2022
Naltrexone Hydrochloride for Habit of Drinking Too Much Alcohol
DO NOT ORDER FROM THIS WEBSITE. I am currently in the ICU because of this medication. It's a legitimate drug, but the website doesn't ask about enough drug interactions. I coded twice and had to call 911 within 30 seconds of swallowing the pill.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about naltrexone hydrochloride

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does naltrexone make you feel?

"Naltrexone blocks the effects of alcohol and narcotics on the brain, making it easier to stop drinking."

Answered by AI

Is naltrexone used for weight loss?

"Naltrexone and bupropion, when combined with a reduced calorie diet and exercise, can help with weight loss and maintenance. This medicine is indicated for people who are overweight or obese and also have weight-related medical problems."

Answered by AI

Does naltrexone help with anxiety?

"Low doses of naltrexone have been shown to decrease anxiety and pain in patients with fibromyalgia, according to a new study. The study, which is published in the journal Pain, examined the effects of naltrexone on a group of fibromyalgia patients. Patients who took low doses of naltrexone reported significantly lower levels of anxiety and pain than those who did not take the drug. Naltrexone is an opioid receptor antagonist that is typically used to treat addiction. However, the new study suggests that the drug may also be effective in treating other conditions, such as fibromyalgia."

Answered by AI

What is naltrexone hydrochloride prescribed for?

"What is Naltrexone?

Naltrexone is a medication that is approved by the FDA to treat both Opioid Use Disorder and Alcohol Use Disorder. Naltrexone is an extended release medication that is given intramuscularly. Naltrexone is a Medication-Assisted Treatment option."

Answered by AI

Clinical Trials for Naltrexone Hydrochloride

Image of Alpha Neuron LLC in Tuscaloosa, United States.

Deep TMS for Alcoholism

18 - 86
All Sexes
Tuscaloosa, AL
The study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will be assigned to the sham treatment. This is a prospective, 6-month, double blind, randomized, controlled, multi-center trial in outpatients recruited in both academic and private research centers. The study population will consist of subjects diagnosed with moderate to severe AUD. The study is comprised of three phases: 1. Pre-study Screening and Baseline Phase 2. Acute Treatment Phase and 3. Maintenance Treatment and Follow up Phase Subjects of all ethnic and gender categories, ages ranging between 18-86 years will be screened for study eligibility according to the inclusion and exclusion criteria. Subjects who meet the eligibility criteria and are willing to sign an informed consent form will be enrolled in the study. The subjects' demographic and baseline characteristics, as well as their overall medical condition will be assessed prior to treatment administration. Eligible patients will be randomized with a 1:1 ratio to one of two study groups (treatment or sham) and stratified by site. Randomization will be employed to avoid bias in the assignment of subjects to treatment group. All subjects will undergo the same treatment regimen, regardless of the assigned treatment group. The acute treatment phase will include 15 treatment visits over a period of 3-5 weeks. The Maintenance Treatment \& Follow-up phase will include one treatment visit per week from the end of the Acute Treatment Phase until the 6 month follow-up visit. At each treatment session, prior to stimulation onset, alcohol related cues will be presented to the subject. After the offset of the alcohol cue presentation, active or sham Deep TMS stimulation will be administered. The study design is directed towards a comparison between active treatment and sham, up to 4 months and 6 months follow-up. Efficacy will be assessed using the primary efficacy measure of the percent heavy drinking days during months 2-4, based on the Time Line Follow Back (TLFB) reporting. Additionally, several subject assessment scales will be used during the course of the study to assess alcohol use and alcohol craving. Safety will be assessed, including monitoring the severity, causality and frequency of all adverse events, vital signs, and physical and neurological examination.
Recruiting
Device
Alpha Neuron LLC (+5 Sites)Brainsway
Image of Wake Forest University Health Sciences in Winston-Salem, United States.

Transcranial Magnetic Stimulation for Alcoholism

21 - 65
All Sexes
Winston-Salem, NC
Alcohol use disorder (AUD) is a complex chronic brain disease characterized by compulsive alcohol use, loss of control over drinking, and negative emotional states. Extensive research has identified the general neural circuitry underlying AUD. There is an exciting opportunity to intervene in AUD using neuromodulation. Transcranial magnetic stimulation (TMS) offers a non-invasive method to modulate brain activity, making it a promising tool for investigating, modulating, and potentially treating AUD. However, the precise effects of TMS on neural circuits involved in AUD and the mechanisms underlying these effects must first be understood. Magnetoencephalography (MEG) is a neuroimaging method that provides direct measurement of brain activity within neural circuits with high temporal resolution. Critically, MEG can measure brain activity in a wide range of frequencies that are consistent with those targeted by TMS. The goal of this proposal is therefore to collect preliminary and feasibility data to support a future NIH grant application that would use MEG to investigate TMS effects in individuals with AUD (iAUD).
Recruiting
Has No Placebo
Wake Forest University Health SciencesMerideth A Addicott, PhD
Image of Washington State University in Spokane, United States.

Virtual Incentive Treatment for Alcoholism

18+
All Sexes
Spokane, WA
The overall objective of this program of research is to utilize phosphatidylethanol (PEth), a blood-based biomarker that can detect alcohol use for up to 28 days to deliver a feasible telehealth-based 26-week CM intervention. This study will test a telehealth PEth-based CM model in a sample of adults with AUD (n=200), recruited via online platforms by randomizing individuals to six months of 1) an online cognitive behavioral therapy for AUD (CBT4CBT) and telehealth PEth-based CM (CM condition) or 2) CBT4CBT and reinforcers for submitting blood samples (no abstinence required) (control condition). Investigators will assess group differences in PEth-defined abstinence and regular excessive drinking (PEth \>= 200 ng/mL), and alcohol-related harms (e.g., smoking, drug use). This study will address important gaps in CM research by assessing outcomes during a 12-month follow-up, which is much longer than most previous CM studies; using a conceptual model to identify predictors of post-treatment abstinence. Investigators will conduct an economic analysis to place the cost of this model in the context of downstream CM-associated cost-offsets and improvements in personal and public health.
Recruiting
Has No Placebo
Washington State UniversityMichael McDonell, PhD
Have you considered Naltrexone Hydrochloride clinical trials? We made a collection of clinical trials featuring Naltrexone Hydrochloride, we think they might fit your search criteria.Go to Trials
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7T MRI for Studying Addiction

18 - 65
All Sexes
Bethesda, MD
Background: \- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies. Objective: \- To develop tasks that investigate a person s behavior that can be used in later studies. Eligibility: * Inpatient participants of another study. They must be physically healthy right-handed adults 18-60 years old. * Healthy right-handed volunteers 18-65 years old. Design: * Participants will be screened with medical history and physical exam. They will have an EKG to record heart activity. They will give blood and urine samples and have a psychiatric interview. * Participants will have between one and three visits. * Participants will be asked about their alcohol drinking to see if they have an alcohol use disorder. * Participants will complete one of three simple computerized tasks either inside the magnetic resonance imagining (MRI) scanner or outside of it. * The MRI scanner takes pictures of the brain. The scanner is a metal cylinder. Participants lie on a table that can slide in and out of the cylinder. They will be in the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The scanner makes loud knocking noises, but they will get earplugs.
Recruiting
Has No Placebo
National Institutes of Health Clinical Center, 9000 Rockville Pike (+1 Sites)Abdolreza Momenan, Ph.D.
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