Appendix I: Workshop Summary Outcome Measures and Success Criteria

On October 8, 1992, the second Clinical Decision Network workshop sponsored by the Medications Development Division (MDD), National Institute on Drug Abuse (NIDA) was held in Bethesda, Maryland. There were 30 attendees at this workshop (see attachment I). The agenda of this workshop addressed specific issues regarding standardized outcome measures and definitions of success of clinical efficacy trials for cocaine addiction pharmacotherapy. These two issues were identified in an earlier workshop (held April 20-21, 1992) as missing elements in current research and development processes for cocaine addiction pharmacotherapy. The meeting program was divided into two parts. The morning session included brief presentations by invited participants, which provided introduction, overview, background, and objectives of the workshops. Two workshops were conducted during the afternoon session, with participants divided into small groups. Discussions were focused on specific issues regarding using biological markers, e.g., urine, to assess cocaine use (workshop I), and defining abstinence as an outcome measure (workshop II) in conducting clinical efficacy trials.