Is Vivitrol Safe and Effective for Alcohol and Opioid Dependence Treatment?

VIVITROL® (naltrexone for extended-release injectable suspension)

Is Vivitrol Safe and Effective for Alcohol and Opioid Dependence Treatment?

  • Opioid blocker
  • Must be administered by a healthcare provider
  • Once-monthly injection
  • Used with counseling
  • Non-addictive and not a narcotic
  • Requires opioid detox of 7–14 days prior to start of treatment

Anyone who receives a VIVITROL injection must not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. Using opioids in the 7 to 14 days before you start receiving VIVITROL may cause you to suddenly have symptoms of opioid withdrawal when you get the VIVITROL injection.

Sudden opioid withdrawal can be severe, and you may need to go to the hospital.

You must be opioid-free before receiving VIVITROL, unless your healthcare provider decides that you don’t need to go through detox first. Instead, your doctor may decide to give your VIVITROL injection in a medical facility that can treat you for sudden opioid withdrawal.

  • VIVITROL is injected by a healthcare provider, about 1 time each month.
  • VIVITROL must be injected by a healthcare provider. Do not attempt to inject yourself with VIVITROL. Serious reaction, some that may require hospitalization, might happen.
  • VIVITROL is given as an injection into a muscle in your buttocks using a special needle that comes with VIVITROL.

See Med Guide for more information.

Patient stories reflect personal experiences. Individual experiences may vary.

«I think that along with counseling and along with the injection, we'd finally found a treatment that was right for her.»

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When used as part of a treatment plan that includes counseling, VIVITROL prevents relapse to opioid dependence after opioid detox.

This data is from a 6-month, double-blind, placebo-controlled, randomized clinical study of 124 opioid-dependent patients treated with placebo and counseling who were compared to 126 opioid-dependent patients treated with VIVITROL and counseling, following opioid detoxification.1,2 Complete abstinence was defined as a negative urine test for opioids and no self-reported use for all weekly visits. During Weeks 5-24 of the study. Data were not collected during Weeks 1-4 of the trial to allow for stabilization of abstinence.

  • 45 126 patients treated with VIVITROL had complete abstinence compared to 28 124 patients treated with placebo from weeks 5-24
  • 1 patient on VIVITROL discontinued due to relapse compared to 17 patients on placebo

Patients were less ly to relapse to dependence2

  • A greater percentage of subjects in the VIVITROL group remained in the study compared to the placebo group

Patients and opioid cravings

  • Craving, described as a «need for opioids» and measured on a scale from 0-100 (with 0 being «none» and 100 being «very much so»), was reported every week
  • Patients treated with VIVITROL experienced an average decrease in craving score of 10.1 from 18.2
  • Patients treated with placebo experienced an average increase in craving score of 0.7 from 21.8

Is there a risk of opioid overdose with VIVITROL?3

Yes. One serious side effect of VIVITROL is the risk of opioid overdose. Using opioids, even in amounts that you used before VIVITROL treatment, can lead to accidental overdose, serious injury, coma, or death.

  • Do not take large amounts of opioids to try to overcome the opioid-blocking effects of VIVITROL.
  • Do not use opioids in amounts that you used before VIVITROL treatment. You may even be more sensitive to lower amounts of opioids:
  • After detox
  • When your next VIVITROL dose is due
  • If you miss a dose of VIVITROL
  • After you stop VIVITROL treatment

Get emergency medical help right away if you:

  • have trouble breathing
  • become very drowsy with slowed breathing
  • have slow, shallow breathing (little chest movement with breathing)
  • feel faint, very dizzy, confused, or have other unusual symptoms.

It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

Is there a risk of severe reactions at the injection site with VIVITROL?3

Yes. One serious side effect of VIVITROL is severe reactions at the site of the injection, including tissue death. Some injection site reactions have required surgery. VIVITROL must be injected by a healthcare provider. Call your healthcare provider right away if you notice any of the following at your injection site:

  • Intense pain
  • The area feels hard
  • Large area of swelling
  • An open wound
  • A dark scab

Tell your healthcare provider about any injection site reaction that concerns you, gets worse over time, or does not get better by two weeks after the injection.

Is there a risk of sudden opioid withdrawal when starting VIVITROL?3

Yes. One serious side effect of VIVITROL is sudden opioid withdrawal. You must stop taking any opioids or opioid-containing medications, including buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL.

If your healthcare provider decides that you don’t need to complete detox first, he or she may give you VIVITROL in a medical facility that can treat sudden opioid withdrawal. Sudden opioid withdrawal can be severe and may require hospitalization.

VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, severe reaction at the injection site and sudden opioid withdrawal.
See Important Safety Information below. Discuss all benefits and risks with a healthcare provider. See Prescribing Information and Medication Guide.


How Can Vivitrol (Naltrexone) Help

Is Vivitrol Safe and Effective for Alcohol and Opioid Dependence Treatment?

Naltrexone is usually taken as a daily pill or administered as a once-a-month injectable. It’s not addictive, and it usually only causes mild and short-lasting side effects.

Naltrexone can only be taken by individuals who have already stopped using alcohol or opioids for over a week. It cannot be used to treat withdrawal symptoms. It needs to be taken continuously in order to reduce cravings.

What Is Naltrexone?

Created by Endo Laboratories in 1963, naltrexone was first developed to treat opioid addiction. It was approved by the FDA for this purpose in 1984.

During the 1980s, the drug showed promise in animal testing for its potential in treating alcohol abuse — promise that was proven in human clinical trials. The trails confirmed that, when combined with therapy, naltrexone reduced alcohol cravings and relapse rates.

Naltrexone is offered under the brand names ReVia and Depade (in pill form) and Vivitrol (as an injectable). As a pill, naltrexone is usually taken at a 25 to 50 mg dose once a day.

As an intramuscular injectable in its extended-release formula, naltrexone is usually administered once a month, at a dose of 380 mg.

Some people prefer Vivitrol since they don’t have to remember to take a pill regularly they do with ReVia or Depade.

Naltrexone works by reducing cravings for alcohol and opioids. It does this by binding and blocking opioid receptors in the body. Thus, it works differently than commonly prescribed buprenorphine and methadone treatments, which trigger opioid receptors in order to reduce cravings.

When taken, naltrexone prevents the blissful and calming effects of opioids. It is also thought to block the pleasurable feelings associated with alcohol use and reduce alcohol cravings.

How Does Naltrexone Help in Treating Addiction?

Naltrexone is not used to treat the immediate withdrawal symptoms associated with opioid or alcohol use disorder. Instead, it’s used to manage opioid and alcohol cravings and addiction. It’s used to help those who have already quit using alcohol or opioids, aiding them in remaining free from drugs and alcohol.

In any form (ReVia, Depade, or Vivitrol), naltrexone works by affecting the opioid system.

There are opioid receptors in the brain, and these receptor sites are acted upon by naturally produced internal neurotransmitters (chemical messengers) that result in the release of painkilling chemicals.

Opioid drugs bind to opioid receptors and mimic the effects of the naturally produced painkilling chemicals.

As an opioid antagonist, naltrexone works by blocking the opioid receptors. This limits the effect opioid drugs can have on a person and possibly reduces opioid cravings. As a result, it is very effective for treating opioid addiction.

For alcohol use disorder, the manner in which naltrexone works is not fully understood. However, it’s thought to be related to the opioid system as well as the neurotransmitter dopamine.

In animal testing, the administration of an opioid agonist (morphine) was shown to increase alcohol consumption, while the administration of an opioid antagonist (such as naltrexone) was shown to decrease alcohol consumption. This research indicates that the opioid system is involved in some way with the enjoyable or “rewarding” aspects of alcohol consumption.

Researchers agreed that the link between alcohol consumption and the opioid system was most ly due to the neurotransmitter dopamine, which plays a major part in the brain’s reward and motivation system. A meta-analysis of 19 studies found that, when compared to a placebo, naltrexone significantly reduced relapse rates of those in short-term treatment for alcohol use disorder.

What Are the Side Effects of ReVia or Vivitrol?

Most side effects of naltrexone are mild and short-lasting, although some people may be more sensitive. These are some of the more common side effects:

  • Upset stomach
  • Anxiety and nervousness
  • Muscle pain
  • Joint pain

More serious side effects are rare, but may include the following:

  • Hallucinations
  • Confusion
  • Tiredness or drowsiness
  • Stomach pain, vomiting, or diarrhea
  • Rash on skin
  • Vision problems (blurriness)

When taken in higher doses (higher than those prescribed clinically), naltrexone can cause liver failure and other serious problems. Stop taking naltrexone and seek medical care if any of the following effects are experienced:

  • Unusual bruising or bleeding
  • Extreme loss of appetite
  • Yellowing of the skin or eyes
  • Dark urine
  • Upper stomach pain

Can Naltrexone Become Addictive?

Naltrexone is considered nonaddictive and non-habit-forming.

Possible Risks or Concerns

Although ReVia, Depade, and Vivitrol are considered safe and effective drugs for treating opioid use disorder and alcohol use disorder, there are some considerations to keep in mind about naltrexone.

  • Naltrexone is prescribed only after an individual has stopped using opioids or alcohol for at least 7 to 10 days. If it’s taken along with the drugs or alcohol, it can cause severe withdrawal symptoms. This means the individual must get through the initial withdrawal process before beginning to manage their cravings with naltrexone.The initial withdrawal symptoms are usually the hardest to overcome during recovery. Withdrawal from alcohol and opioids can be extremely uncomfortable, dangerous, and even life-threatening. Undergoing withdrawal in a professional recovery setting (often with the help of medication-assisted treatment to manage the withdrawal symptoms) may be necessary to ensure a safe and successful initial withdrawal period.
  • Individuals with acute liver or kidney problems, or hepatitis, should not take naltrexone.
  • Although naltrexone has shown promise as a safe opioid treatment for pregnant women, there is not enough research in this area yet. Pregnant women should not take naltrexone without approval from their doctor.
  • Because naltrexone blocks some of the effects of opioids and alcohol, individuals who have used naltrexone and then return to drinking or using opioid drugs may be more sensitive to the effects of drugs or alcohol, or not feel the full effects of the amount they’ve used. This may lead to overdose or dangerous behavior.
  • In order for naltrexone to manage addiction, individuals must continue to take the medication. A missed dose could lead to an increase in cravings or relapse. Vivitrol is sometimes preferred in order to avoid forgetting to take a pill.
  • Naltrexone should never be used with high doses of opioid drugs. This can result in coma or death.
  • Before starting naltrexone, an individual should discuss all their medications and any possible interactions they may have with naltrexone with their doctor. Medications of potential concern include cough medications, disulfiram, or thioridazine
  • Naltrexone may affect an individual’s thoughts and reaction time. Be familiar with how you react to the medication before driving or performing any activity that requires you to be alert.

Is Naltrexone Alone Enough to Treat Addiction?

Research has indicated that naltrexone is an effective tool for helping individuals with alcohol use disorder or opioid use disorder to control and reduce their cravings. However, substance use disorders are complex and often require a more holistic approach in order to provide an individual with a chance at sustained recovery.

There is no cure for addiction. It is a chronic condition that must be consistently managed over time.

Naltrexone is not a cure-all for addiction. Because naltrexone cannot be taken during withdrawal, an individual must get through what is perhaps the most difficult part of their recovery before they can even start taking it. Once they have gotten through withdrawal, they can begin taking ReVia or Vivitrol to control their cravings.

Support is critical during withdrawal and early recovery. You’ll reduce your chances of relapse if you detox in a structured program that offers medical supervision and psychological support. You may be given other medications during detox, including other forms of MAT or medications that treat individual withdrawal symptoms, such as medications to combat insomnia or nausea.

In this type of program, you’ll also receive psychological support around the clock, helping you to process what you’re going through and restricting your access to substances that could lead to relapse. If you attempt to detox at home on your home, relapse is highly ly.

If you return to use after a period of abstinence, your tolerance may be lower. Taking the same dose, or drinking the same amount, you were accustomed to before could more quickly result in overdose.

When Is Naltrexone a Good Choice?

While it’s not a fast fix for addiction, naltrexone can play an important role in recovery for many individuals, particularly those engaged in a comprehensive treatment program with long-term plans for recovery. For most individuals with a substance use disorder, withdrawal is just the first step on a long journey. They need tools and skills to succeed in recovery and beyond.

Along with therapy where participants learn invaluable coping and life skills, medication-assisted treatment (MAT) can help to make everyday life more manageable and reduce the risk of relapse. Naltrexone may be an ideal choice for many because it isn’t habit-forming, and has generally mild side effects. It should be used as part of a comprehensive treatment program.


Effective Treatments for Opioid Addiction | National Institute on Drug Abuse

Is Vivitrol Safe and Effective for Alcohol and Opioid Dependence Treatment?

  • Over 2.5 million Americans suffer from opioid use disorder which contributed to over 28,000 overdose deaths in 2014.1,2
  • Use of opioids, including heroin and prescription pain relievers, can lead to neonatal abstinence syndrome as well as the spread of infectious diseases HIV and Hepatitis.

Medications, including buprenorphine (Suboxone®, Subutex®), methadone, and extended release naltrexone (Vivitrol®), are effective for the treatment of opioid use disorders.

  • Buprenorphine and methadone are “essential medicines” according to the World Health Organization.3
  • A NIDA study shows that once treatment is initiated, a buprenorphine/naloxone combination and an extended release naltrexone formulation are similarly effective in treating opioid use disorder. However, because naltrexone requires full detoxification, initiating treatment among active users was more difficult with this medication. Once detoxification was complete, both medications had a similar effectiveness.
  • Medications should be combined with behavioral counseling for a “whole patient” approach, known as Medication Assisted Treatment (MAT).

View Transcript

MAT Decreases opioid use, opioid-related overdose deaths, criminal activity, and infectious disease transmission.4,5,6 After buprenorphine became available in Baltimore, heroin overdose deaths decreased by 37 percent during the study period, which ended in 2009.6

MAT Increases social functioning and retention in treatment.4,5 Patients treated with medication were more ly to remain in therapy compared to patients receiving treatment that did not include medication.4

Treatment of opioid-dependent pregnant women with methadone or buprenorphine Improves Outcomes for their babies; MAT reduces symptoms of neonatal abstinence syndrome and length of hospital stay.7

In November 2017, the U.S.

Food and Drug Administration approved Sublocade, the first once-monthly buprenorphine injection for moderate-to-severe opioid use disorder in adult patients who have initiated treatment with the transmucosal buprenorphine-containing products.

This medication, in addition to Probuphine®, an implantable buprenorphine formulation approved in May 2016, eliminate the need for daily dosing and improve treatment retention. Read the Director's blog — Probuphine: A Game-Changer in Fighting Opioid Dependence.

Reaching Patients in Need

The emergency department (ED) provides a prime opportunity to screen patients for opioid use disorder and initiate MAT. Patients who initiate MAT in the ED are more than twice as ly to remain engaged in treatment compared to patients referred for treatment. Read the JAMA article — Emergency Department–Initiated Buprenorphine/Naloxone Treatment for Opioid Dependence

A recent study found treatment with extended-release naltrexone reduced relapse rates among criminal justice involved adults with a history of opioid dependence. Read the NEJM article Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders.

Medications are Not Widely Used

Less than 1/2 of privately-funded substance use disorder treatment programs offer MAT and only 1/3 of patients with opioid dependence at these programs actually receive it.8

  • The proportion of opioid treatment admissions with treatment plans that included receiving medications fell from 35 percent in 2002 to 28 percent in 2012.9
  • Nearly all U.S. states do not have sufficient treatment capacity to provide MAT to all patients with an opioid use disorder.10

Addressing Myths About Medications

Methadone and buprenorphine DO NOT substitute one addiction for another. When someone is treated for an opioid addiction, the dosage of medication used does not get them high–it helps reduce opioid cravings and withdrawal. These medications restore balance to the brain circuits affected by addiction, allowing the patient’s brain to heal while working toward recovery.

Diversion of buprenorphine is uncommon; when it does occur it is primarily used for managing withdrawal.11,12 Diversion of prescription pain relievers, including oxycodone and hydrocodone, is far more common; in 2014, buprenorphine made up less than 1 percent of all reported drugs diverted in the U.S.13

Vaccines currently under development target opioids in the bloodstream and prevent them from reaching the brain and exerting euphoric effects.

Researchers are exploring the potential of Transcranial Direct Current Stimulation, a novel, non-invasive brain stimulation technique, for treating opioid use disorder.

Improving Treatment Delivery — Researchers are exploring how the health care system can reach more people in need of treatment and helping providers understand which treatments will be most effective for which patients.

Reaching Justice-Involved Youth —  NIDA-funded research is aimed at identifying the most effective strategies for improving the delivery of evidence-based prevention and treatment services for youth through our Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS) initiative. Read more about Justice System Research Initiatives.

Additional Information

If you or someone you care about has an opioid use disorder, ask your doctor about available MAT options and about naloxone, an opioid antagonist that can reverse an opioid overdose.


This publication is available for your use and may be reproduced in its entirety without permission from NIDA. Citation of the source is appreciated, using the following language: Source: National Institute on Drug Abuse; National Institutes of Health; U.S. Department of Health and Human Services.

NIDA. 2016, November 1. Effective Treatments for Opioid Addiction. Retrieved from

NIDA. «Effective Treatments for Opioid Addiction.» National Institute on Drug Abuse, 1 Nov. 2016,

NIDA. Effective Treatments for Opioid Addiction. National Institute on Drug Abuse website. November 1, 2016


VIVITROL Treatment: Once A Month Injection for Opioids & Alcohol

Is Vivitrol Safe and Effective for Alcohol and Opioid Dependence Treatment?

Relapse is an unfortunate reality of addiction. In fact, relapse rates range from 50-90%. This frightening statistic is why medically-assisted treatment (MAT) options exist; to help people suffering from addiction achieve and maintain recovery. Some options include Methadone, Suboxone, and VIVITROL®.

VIVITROL® is prescription injectable medicine that can be used to prevent a relapse to opioid dependence or alcohol after a person has gone through detoxification. When combined with a solid alcohol and drug recovery program, such as counseling and one-on-one therapy, VIVITROL® can help a person stay in recovery longer.

Recovery Centers of America provides medication assisted treatment (MAT) that includes VIVITROL® for patients who are hoping to achieve sobriety from opioid addiction, including addiction to alcohol and opioids. Here are a few things you’ll want to know about VIVITROL®.

What is VIVITROL®?

VIVITROL® is the brand name for naltrexone and is an opioid blocker that is a monthly injection administered by a healthcare provider. VIVITROL® was approved by the Food and Drug Administration in 2006 to prevent relapse in those recovering from an alcohol use disorder.

Naltrexone minizines cravings for alcohol differently than other types of alcohol prevention medicines, which can make you sick when alcohol is consumed. VIVITROL® was also approved by the FDA in 2010 to treat opioid addiction.

It was discovered VIVITROL® could aid in opioid relapse after a study found people who took VIVITROL® during rehabilitation stayed in the program, longer and were more ly to remain abstinent and avoid relapse.

Before beginning VIVITROL®, a person must be opioid-free for at least 7 to 14 days to avoid sudden opioid withdrawal. Naltrexone removes opioids from opioid receptors; therefore, if a person is going through a medically assisted detoxification via buprenorphine, VIVITROL® can stop the medicine from working and make withdrawal symptoms worse.

All forms of naltrexone work to stop the euphoria that alcohol and opioids can cause. While VIVITROL® prevents endorphins from binding opioid receptors in people who consume alcohol, it also blocks opoid drugs from binding to opioid receptors in the brain. Not only can this make treatment more effective, but it can also help with relapse.

VIVITROL® treatment program

Unfortunately, there is no magic cure that’ll put a stop to substance use disorder. However, VIVITROL® can help patients achieve and maintain their recovery.

One study found that people who use VIVITROL® in addition to counseling to treat opioid addiction have 90% opioid-free weeks, compared to 35% who took a placebo.

Additionally, people who used VIVITROL® in addition to rehab and continued therapy were 17 times less ly to relapse than those who did not use VIVITROL®.

VIVITROL® vs Suboxone

Buprenorphine (brand name Suboxone) is an opioid agonist that can help reduce opioid use or protect against relapse. Naltrexone (brand name VIVITROL®) is an evidence-based medication for opioid use disorder.

VIVITROL® is an extended-release injection delivered monthly, while Suboxone is given in oral pill or oral film form. Some consider VIVITROL® a lower maintain option, since it is monthly, and also treatments for alcohol use disorder.

Suboxone can reduce opioid withdrawal symptoms, while VIVITROL® cannot.

VIVITROL® and Suboxone can help reduce cravings and protect against relapse. VIVITROL® requires a period of opioid abstinence, while Suboxone does not.

What happens if you take opiates while on VIVITROL®?

Individuals should not take opiates while on VIVITROL®, as this can be dangerous and result in overdose. Because VIVITROL® blocks the effects of drugs, a person may take higher doses in order to feel the effects.

The danger in this is that they can still overdose even when they don’t feel the effects. VIVITROL® can also impact a person’s tolerance to opioids, increasing their sensitivity.

However, a personal doesn’t usually know this has happened, so when they take the same amount of opioids they did before they started VIVITROL®, they may end up overdosing.

How does VIVITROL® work?

VIVITROL® is an opioid antagonist – or blocking – medication. Antagonists create a barrier that blocks opioid molecules form attaching to opioid receptors.

While antagonists attach to opioid receptors, they do not cause the release of dopamine. In other words, the person will get relief without getting high.

Antagonists such as VIVITROL® are non-addictive and don’t lead to physical dependence.

What drugs does VIVITROL® block?

VIVITROL® blocks the effects of opioids, heroin and opioid pain medication (such as codeine, fentanyl, hydrocodone, etc.). That is why the risk of overdose is higher when taking VIVITROL® – a person may not feel the effects of the drug, even if it’s the same dose they were taking before starting VIVITROL®, and take more.

How long does VIVITROL® shot block opiates?

The VIVITROL® blocks opioid receptors for one month at a time. Once given, it begins a blocking effect right away. It slowly decreases and then eventually goes away over time. Generally, VIVITROL® shots are given once every 28 days.

How much does VIVITROL® cost?

with most other types of treatment for disease, the cost of VIVITROL® depends on your insurance and the coverage it provides. The range of VIVITROL® treatment program costs ranges depending on the facility and may be covered by both private and public insurance.

How long do VIVITROL® side effects last?

As with most medications, the type, severity and range of side effects from VIVITROL® vary from person to person. Some individuals may find the side effects go away with a day or two, while others may have lingering side effects. Your doctor may be able to help you manage these effects.

What happens if you drink on VIVITROL®?

According to the National Institute on Alcohol Abuse and Alcoholism (NIAAA), individuals who use naltrexone (VIVITROL®) while drinking alcohol do not face any significant dangers. They may see symptoms similar to those of alcohol use, including poor coordination, decreased response time, slower rate of thinking and responding, and a decrease in the urge to drink.

VIVITROL® side effects

Side effects can include risk of opioid overdose, reactions at the injection site, sudden opioid withdrawal and liver damage or hepatitis. Common side effects include nausea, headache, dizziness, anxiety, nervousness, restlessness, irritability, tiredness, loss of appetite, increased thirst, muscle or joint aches, weakness, sleep problems, decreased sex drive, or impotence.

Recovery Centers of America Medication Assisted Treatment (MAT) Clinic Locations

To learn about RCA’s Suboxone and Methadone treatment facilities, click one of the links below. Currently, we have two locations in New Jersey: Trenton Healthcare Clinic in Trenton and Bravo Medical in Somerdale (not far from Camden). New MAT clinic locations coming soon.

New Jersey MAT Clinic Locations
Methadone and Suboxone in Trenton
Methadone and Suboxone in Somerdale (10 miles from Camden)
Methadone and Suboxone in Iselin

Pennsylvania MAT Clinic Locations
Methadone and Suboxone in Lansdowne

Click here to see all Recovery Centers of America locations (including MAT, inpatient and outpatient) on a map.


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