The rationale and methods of the COMBINE study have been described in detail elsewhere (bCOMBINE Study Research Group, 2003b; Anton and Randall, 2005; Swift and Pettinati, 2005). Briefly, COMBINE was designed with the goal of determining whether alcohol dependence treatment outcomes can be improved upon by combining specific pharmacotherapies and behavioral therapies. Overall, the study included 1383 participants at 11 sites in the U.S. Participants were alcohol dependent adult outpatients who had been drinking heavily during the preceding 90 days but were abstinent for at least 4 days at randomization and not experiencing significant alcohol withdrawal. Patients were excluded if they had serious mental illness, were currently dependent on any drug other than alcohol, nicotine, or marijuana, had any significant recent opioid use, had any medical condition that interfered with study participation, or required medication that would increase the potential risks of the study.
