The Value of Ongoing Evaluation in Adopting Buprenorphine-Naloxone Short-term Taper

1. The Value of Ongoing Evaluation in Adopting Buprenorphine-Naloxone Short-term Taper Gregory S. Brigham, Ph.D. Maryhaven, Columbus, Ohio NIDA CTN Ohio Valley Node American Psychological Association, San Francisco, CA (August 2007) Support from The Ohio Valley Node of the NIDA CTN, NIDA 5 U10 DA13732-04

2. Topics • A medication example of moving from clinical trial to clinical practice: Buprenorphine short-term taper at Maryhaven • Importance of ongoing monitoring, evaluation and, feedback on provider modifications to interventions

3. Partial vs. Full Opioid Agonist death Opiate Full Agonist (e.g., methadone) Effect Partial Agonist (e.g. buprenorphine) Antagonist (e.g. Naloxone) Dose of Opiate

4. NIDA CTN Buprenorphine-Naloxone Detoxification Protocols • Two, open-label, randomized clinical trials, residential & outpatient. • Compared Buprenorphine-Naloxone (n = 77) and Clonidine (n = 36) for 13 day opiate detoxification in residential. • Initiated in 6 Community Treatment Programs. • Outcome: • BUP/NX = 77% (59) Present and Clean on day 13 • Clonidine = 22% (8) Present and Clean on day 13 Ling, W., Amass, L., Shoptaw, S., Annon, J. J., Hillhouse, M., Babcock, D., Brigham, G., Harrer, J., Reid, M., Muir, J., Buchan, B., Orr, D., Woody, G., Krejci, J., Ziedonis, D., & Buprenorphine Study Protocol Group (2005). A multi-center randomized trial of buprenorphine-naloxone versus clonidine for opioid detoxification: Findings from the National Institute on Drug Abuse Clinical Trials Network. Addiction, 100, 1090-1100.

5. Adopt This Treatment? “We must find a better way to treat these patients, more that half of them are not continuing with treatment” Maryhaven Medical Director

6. Three Groups • Prior to BNX implementation, n = 157 • Admitted prior to BNX Implementation between 6/10/03 - 8/24/03 • After BNX implementation but no BNX, n = 227 • Admitted between 8/25/03 - 1/31/04, but did not take BNX • Received BNX, n = 64 • Admitted between 8/25/03 - 1/31/04 and received BNX

7. BUP/NX Taper at Maryhaven

8. Prior to BNX 100 No BNX BNX % of Patients 80 60 40 20 0 Female Male African White American Patient Demographics

9. A B Prior To BNX No BNX 100 BNX TX 84 82 % ofPatients 80 56 54 60 40 32 31 20 0 Completed Detoxification Continued Early TX * p = .0001 Program Engagement Treatment Completion & Engagement * * • Brigham, G. S., Amass, L., Winhusen, T., Harrer, J. M., & Pelt, A. (2007). Using buprenorphine short-term taper to facilitate early treatment engagement . Journal of Substance Abuse Treatment, 32, 349-356.

10. QI Report Detects Problem • Maryhaven QI data showed decline in completion rates as the number of admissions increased. • Further investigation indicated that initial indicator of completion drop-off was not accurate but transfer drop off was substantial. • Chart review revealed adaptation of the treatment to treat greater number of patients with the unintended result of lower success rates.

11. Two Groups • 100 patients admitted for short-term Buprenorphine Taper between 6/01/04 & 12/31/04 • BNX 7 Day Taper, n = 29 • BNX 13 Day Taper, n = 71

12. BUP Taper Admits June Thru December 2004

13. Taper Completion & Engagement

14. Clinical Significance of Transfer • Detoxification is not a treatment for addiction • (National Institute on Drug Abuse (1999). Principles of drug addiction treatment: A research-based guide. NIH Publication No. 99-4180 • A critical quality indicator for detoxification is engagement in ongoing treatment • Washington Circle Group (McCorry, F., Garnick, D.W., Bartlett, J., Cotter, F., & Chalk, M. (2000). Developing performance measures for alcohol and other drug services in managed care plans. Joint Commission on Quality Improvement, 26 (11), 633-643.; Garnick, D.W., Lee, M.T., Chalk, M., Gastfriend, D., Horgan, C.M., McCorry, F., McLellan, A.T., & Merrick, E.L. (2002). Establishing the feasibility of performance measures for alcohol and other drugs. Journal of Substance Abuse Treatment, 23, 375-385. ) • Center for Substance Abuse Treatment (CSAT). Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04 -3939. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2004.

15. Risks of Opiate Detoxification • BNX detoxification taper without ongoing treatment leads to rapid relapse • Fiellin, D.A., Kleber, H., Trumble-Hejduk, J.G., McLellan, A.T., & Kosten, T.R. (2004). Consensus statement on office-based treatment of opioid dependence using buprenorphine. Journal of Substance Abuse Treatment, 27, 153-159. • Return to opioid use after even a brief period of abstinence may increase the risk for accidental drug overdose • Strang, J., McCambridge, J., Best, D., Beswick, T. Bearn, J., Rees, S., & Gossop, M. (2003). Loss of tolerance and overdose mortality after inpatient opiate detoxification. British Medical Journal. May 2003; 959-960.

16. Timeline of Opiate Treatment Innovations at Maryhaven • 2001 BUP Clinical Trial • 2003 Adoption of BUP Taper • 2005 Adoption of BUP Maintenance • 2007 Open OTP with both Methadone and BNX

17. Conclusion • Identify important outcomes • Measure & monitor outcomes • Evaluate impact of provider modifications to intervention; even small shifts in practice can have significant unintended consequences • Provide timely feedback to clinicians and other stake holders