VIVITROL Efficacy for Opioid Dependence
VIVITROL–Clinically proven to prevent relapse to opioid dependence, following detoxification7†
VIVITROL blocks the subjective effects of opioids. Complete abstinence was sustained by 36% of patients treated with VIVITROL compared with 23% of patients treated with placebo from weeks 5-24.†7
†The efficacy of VIVITROL in the treatment of opioid dependence was evaluated in a 24 week, placebo-controlled, multi-center, double-blind, randomized trial of opioid-dependent (DSM-IV) outpatients, who were completing or had recently completed detoxification. Subjects were treated with an injection every 4 weeks of VIVITROL 380 mg or placebo. Oral naltrexone was not administered prior to the initial or subsequent injections of study medication. Standardized, manual-based psychosocial support was provided on a biweekly basis to all subjects in addition to medication.
Unintended precipitation of opioid withdrawal
To prevent occurrence of an acute abstinence syndrome (withdrawal) in patients dependent on opioids, or exacerbation of a preexisting subclinical abstinence syndrome:
- Patients, including those treated for alcohol dependence, must be opioid free for a minimum of 7-10 days before starting VIVITROL treatment
- Patients must be free of all opioid-containing medications, including medications used to treat opioid dependence (eg, methadone, Suboxone® [buprenorphine and naloxone] Sublingual Film [Clll], Subutex® [buprenorphine HCI sublingual tablets])
Patients treated for alcohol dependence with VIVITROL should be assessed for underlying opioid dependence and for any recent use of opioids prior to initiation of treatment with VIVITROL. Precipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where the prescriber had been unaware of the additional use of opioids or dependence on opioids.
Because the absence of an opioid drug in the urine is often not sufficient proof that a patient is opioid free:
- A naloxone challenge test should be employed if the prescribing physician feels there is risk of precipitating a withdrawal reaction following administration of VIVITROL