2.  Is buprenorphine that good?  Is medical management (MM) that good?  Is counseling that ineffective for this population?  Have the studies been designed properly?  What are the minimal requirements for counseling and good enough outcomes?

7. Why would everything we’ve learned about treating opioid dependence not apply to buprenorphine?

8. McLellan et al 1993

12. Hser et al., under review

16. MMMM+CBT MMMM+CBT Randomized 7170 Protective transfer or MMP 28 (39%)19 (27%) Missed visits 1124 Retained/success at 24 weeks (12 weeks after CBT stopped) 45%39% *6/12 sessions attended Supervision, no fidelity testing

18. CBTCM CBT+CM NT Randomized 5349 51 Completed treatment phase 16 weeks 37/53=69%35/49=71%34/49=69%28/51=54% CBT and CM stop Complete medication phase (32 weeks) 26/53=49%28/49=57%24/49=49%22/51=43% **Payments for assessments, including urines, CM reinforcement for opioid-negative urines only, no data on CBT fidelity, 73% compliance

19. MMMM + Counseling Randomized 324329 Success Phase 1 (12 weeks) 24 (7%)19 (6%) Start phase 2 180 Success Phase 2 (24 weeks) 84 (47%)93 (52%) Success at post taper follow- up 13 (7%)18 (10%)

21. MM+ CMMM+CM+TES Randomized7892 Retained/success at 12 weeks 64%80% ** No follow-up reported Why were these outcomes so much better?

22. Bup + Standard careBup + Therapist CRABup + Computer CRA (TES) Randomized45 Retained at 24 weeks 58%53%62% Negative urines (opioids and cocaine) 57%73%70% Why were these outcomes so much better?

24. Reason% Discharge involuntarily/conflict with staff24% Discharge for missing too many days17% Program conflicts with other obligations (work, home) 17% Sought another provider14% Discharged due to too many positive urines9% Incarcerated7% Did not like buprenorphine4% Financial4% Wanted to keep using drugs4% Finished treatment successfully4%

29. Anxiety Pain Cocaine

30. Core principles: CBT4CBT development

31. Demo at CBT4CBT.com

32. Overview: CBT4CBT methadone trial Carroll et al., Am J Psych. 2014

33. Carroll et al., AJP, 2014

34. Kiluk et al, Addiction, 2010 Better response

37. A dherence A ttendance A bstinence A lternate activities A ccessing support

40. Is medical management (MM) that good? Compared to nothing, of course Moderate response, high attrition, high relapse implies significant room for improvement (floor, not ceiling effects) MM not scalable, nor representative of usual care in many settings Many providers new to addiction may be uncomfortable providing MM, access to addiction expertise seen as significant barrier

41. Is counseling ineffective for this population? No behavioral therapy yet tested without MM Tests of CM, CBT not done in accordance with current with methodological standards (targeting compliance, cocaine, other behaviors) Different models need to be considered Stepped models Technology based models Treating to success

42. Have the studies been designed properly? Highly unusual for CM not to be effective Cannot conclude counseling not effective for bup without significant MM Consider outcomes other than ‘retention = success’ What are the minimal requirements for counseling and good enough outcomes?

43. Supported by NIDA P50 DA09241, R37 DA15969, U10 DA015831, R01 DA035058, R01 DA03069 & NIAAA AA021405 Psychotherapy Development Center website (training videos and resources, manuals, datasets): pdc.yale.edu CBT4CBT demo, etc at: CBT4CBT.com Kathleen.carroll@yale.edu