The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone
combination tablet for alternate-day dosing and determine whether multiples of the daily
dose are necessary to maintain an effective alternate day dosing regimen.
Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as
daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day
dosing is equal to that given during daily dosing.
Individuals must be currently opioid dependent and meet FDA criteria for narcotic
maintenance treatment. Co-morbid substance abuse or dependence disorders may also be
present. Individuals must be healthy despite drug dependency.
Individuals with evidence of an active Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness,
organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular
disease) or pregnant female subjects are excluded from study participation.