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SAMHSA News - May/June 2007, Volume 15, Number 3

Treating Alcohol Dependence: Naltrexone Advisory

cover of SAMHSA's Spring 2007 Substance Abuse Treatment Advisory on Naltrexone - click to view

SAMHSA recently issued an advisory explaining the use of a new extended-release injectable form of naltrexone—a medication used to treat alcohol dependence—that only needs to be taken once every 4 weeks.

An effective extended-release form of naltrexone has been sought after for 30 years and may help patients who might otherwise skip the required daily doses of the existing oral naltrexone to continue consistent treatment.

“Taking medication daily can become a problem of medication adherence that decreases medication effectiveness,” said addiction psychiatrist Kenneth Hoffman, M.D., M.P.H., of SAMHSA’s Center for Substance Abuse Treatment, Division of Pharmacologic Therapies.

“A monthly dose of naltrexone, rather than a daily dose, can eliminate this problem. By removing medication adherence as a problem, both patient and treatment provider can focus on steps needed to maintain a successful recovery program,” Dr. Hoffman said.

The SAMHSA advisory includes a table listing dosage, drug interactions, precautions, and potential adverse reactions for the new injectable naltrexone compared to the existing oral form.

The advisory also addresses safety and efficacy questions about the new medication and includes tips on how substance abuse specialty treatment advisors can incorporate injectable naltrexone.

Approved by the Food and Drug Administration in April 2006, extended-release naltrexone (Vivitrol) is injected by the prescribing medical provider into a patient’s muscle tissue, where it is absorbed into the bloodstream. The injectable naltrexone remains effective for about a month.

While the exact mechanism is unknown, both oral and injectable naltrexone work by blocking the opiate receptors in the brain that make drinking pleasurable.

“The addition of injectable naltrexone to the menu of available treatments provides another valuable option, especially for patients who have difficulty adhering to oral medication regimens,” said Raye Litten, Ph.D., Associate Director of the Division of Treatment and Recovery Research at the National Institute on Alcohol Abuse and Alcoholism.

The SAMHSA advisory should help to make both clinicians and patients aware of this most recent treatment innovation.

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Efficacy Study

To test the effectiveness of injectable naltrexone, researchers conducted a 6-month study. Alcohol-dependent patients were randomly assigned to take either 190 mg of Vivitrol, 380 mg of Vivitrol, or a placebo. All patients received addiction counseling in addition to medication.

The researchers found that patients treated with 380 mg of Vivitrol in conjunction with counseling had fewer days on which they drank heavily than those treated with a placebo.

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Adverse Reactions

Few adverse reactions occurred during the clinical trials of injectable naltrexone. Both oral and injectable forms of naltrexone can cause serious withdrawal reactions from recent use of opioids such as heroin, and opioid-containing medications such as morphine and codeine.

Doctors should ensure that patients have not taken opioids or opioid-containing medication in the 7 days prior to administering injectable naltrexone.

Rare but significant side effects have been reported. These include injection site reactions that do not improve over time, shortness of breath, yellowing of the skin or eyes, or suicidal ideation and behavior. Patients are encouraged to report these symptoms to their doctors immediately.

Patients should be informed about the potential benefits of the extended-release naltrexone and reminded that medication is just one part of a comprehensive approach to alcohol dependence treatment.

The SAMHSA advisory emphasizes that medications for alcohol use disorders do not replace counseling. Treatment with extended-release naltrexone is meant to be one part of a comprehensive management program that includes psychosocial support and participation in a “12-step” or other mutual-help group program. End of Article

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Read the Advisory

“Naltrexone for Extended-Release Injectable Suspension for Treatment of Alcohol Dependence” is SAMHSA’s spring 2007 Substance Abuse Treatment Advisory, Volume 6, Issue 1. The advisory is available in PDF format on the SAMHSA Web site at
. For a print copy, contact SAMHSA’s National Clearinghouse for Alcohol and Drug Information at 1 (800) 729-6686 or 1 (800) 487-4889 (TDD).

For a list of other SAMHSA advisories available online, visit
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Inside This Issue
Expanding HIV Assistance:
Outreach, Testing for
At-Risk Individuals
Part 1
Part 2
Resources on HIV/AIDS
HIV/AIDS Consumer Guide

From the Administrator: On Capitol Hill

Grants: Manual Clarifies Application Process

Children's Mental Health

Virginia Tech Tragedy: Coping with Trauma

Psychological First Aid

Veterans, Families: New Resources

Around the World Treatnet: Improving Treatment Around the Globe

Expanding Treatment in Central America

Treating Alcohol Dependence: Advisory

Recovery Month: Toolkit, PSAs Help Planning Efforts

PRISM Awards in Spotlight

Depression: Reports Offer Statistics

Mental Health Report Available

TAP 21A: Competencies for Clinical Supervisors

HBCU Conference Highlights Workforce

Homelessness Web Site Launched

STD Rates: Alcohol, Drug Use Linked

Staff in the News:
Dr. Kenneth S. Thompson


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SAMHSA News - May/June 2007, Volume 15, Number 3