Participants were recruited from individuals enrolled in one of the methadone maintenance programs of the APT Foundation, the largest provider of methadone maintenance services in New Haven, Connecticut. Participants were English-speaking adults, stabilized on methadone (same dose>2 months), who met DSM-IV criteria for current (within the past 30 days) cocaine dependence. As in our previous trial, exclusion criteria were minimized in order to facilitate recruitment of a broad and clinically representative group of individuals enrolled in this setting. Thus, individuals were excluded only if (1) they failed to meet DSM-IV criteria for current cocaine dependence, (2) had an untreated/unstabilized psychotic disorder or had current suicidal/homicidal ideation such that more intensive treatment was indicated, or (3) could not read at a 6th grade level (required for provision of written informed consent and completion of assessment instruments).
As shown in the CONSORT diagram (Figure 1), 101 of the 154 individuals screened were determined to be eligible for the study, provided written informed consent and were randomized. Following description of the study and provision of written informed consent approved by the Yale University School of Medicine Human Investigations Committee, participants were randomized to either TAU or CBT4CBT, using a computerized urn randomization program (29 ) to balance treatment groups with respect to gender, ethnicity, education level, and frequency of cocaine use at baseline.