VIVITROL clinical trial results :: VIVITROL Information

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VIVITROL—substantial, rapid, and sustained results for abstinence and ongoing recovery

When VIVITROL was added to psychosocial therapy*…
Reductions were substantial3

According to the Substance Abuse and Mental Health Services Administration/Center for Substance Abuse Treatment, 4 days is the US norm (median duration) for detoxification22
The above results are from a post hoc subgroup analysis of a 6-month, multicenter, double-blind, placebo-controlled clinical trial of alcohol dependent patients. This subset analysis evaluated patients who were abstinent for 4 or more days prior to treatment initiation3
The approval of VIVITROL was based on a subset of patients who were able to abstain for 7 days prior to treatment initiation3

*The psychosocial support used with all subjects was BRENDA, a low-intensity intervention designed to facilitate direct feedback of alcohol-related consequences. BRENDA consists of biopsychosocial assessment, reporting the assessment to the patient, an empathetic approach, identified and stated patient needs, direct advice regarding drinking behavior, and assessment of treatment adherence.

When VIVITROL was added to psychosocial therapy*…
Results were rapid4

"Potential clinical implications of the rapid, early onset of effect…include facilitation of early engagement in treatment, motivation to continue treatment, and focus on the goals established in counseling.4"

– Ciraulo et al. Journal of Clinical Psychiatry, 2008

The above results are from a post hoc analysis of a randomized, double-blind, placebo-controlled study of patients who had a minimum of 2 heavy drinking episodes per week during the month prior to screening. Patient inclusion did not require detoxification, abstinence, or intent to abstain from alcohol4
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration1

When VIVITROL was added to psychosocial therapy*…
Results were sustained for 6 months3

"Most treatment programs and providers identify abstinence as the goal of treatment…abstinence may be especially important for recovery of neurocognitive deficit, which, in turn, may promote ongoing recovery.3"

– O'Malley et al. Journal of Clinical Psychopharmacology, 2007

The above results are from a post hoc subgroup analysis of a 6-month, multicenter, double-blind, placebo-controlled clinical trial of alcohol dependent patients. This subset analysis evaluated patients who were abstinent for 4 or more days prior to treatment initiation3

Indication1

VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.

Patients should not be actively drinking at the time of initial VIVITROL administration.

Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.

Important Safety Information1

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.
Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.
The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses.
Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.

VIVITROL is contraindicated in patients receiving or dependent on opioids, in acute opioid withdrawal, and in those who have failed the naloxone challenge test or have a positive urine screen for opioids; and in those with previous hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent.

Patients must be opioid free for a minimum of 7-10 days before treatment. Attempts to overcome opioid blockade due to VIVITROL may result in fatal overdose. In prior opioid users, use of opioids after discontinuing VIVITROL may result in fatal overdose because patients may be more sensitive to lower doses of opioids. Patients requiring reversal of the VIVITROL blockade for pain management should be monitored by appropriately trained personnel in a setting equipped for cardiopulmonary resuscitation.

Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. Injection site reactions not improving may require prompt medical attention. Alcohol dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thinking. Caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment.

The most common adverse events associated with VIVITROL in clinical trials were nausea, vomiting, headache, dizziness, asthenic conditions, and injection site reactions.