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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)

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the value of ongoing evaluation in adopting buprenorphine naloxone short term taper

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

topics
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
slide3

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

nida ctn buprenorphine naloxone detoxification protocols
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.

adopt this treatment
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

three groups
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
patient demographics

Prior to BNX

100

No BNX

BNX

% of Patients

80

60

40

20

0

Female

Male

African

White

American

Patient Demographics
treatment completion engagement

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.
qi report detects problem
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.
two groups
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
clinical significance of transfer
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.
risks of opiate detoxification
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.
timeline of opiate treatment innovations at maryhaven
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
conclusion
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