Treating Alcohol Dependence: Naltrexone Advisory
By Erin Bryant
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.
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