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Buprenorphine and the NIDA CTN: Research to Practice. Walter Ling & Richard Rawson ISAP/UCLA XIII World Congress of Psychiatry September 14, 2005 Cairo, Egypt rrawson@mednet.ucla.edu www.uclaisap.org. Full agonist. -. Super agonist. -. fentanyl. morphine/heroin. hydromorphone.

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buprenorphine and the nida ctn research to practice
Buprenorphine and the NIDA CTN: Research to Practice

Walter Ling & Richard Rawson

ISAP/UCLA

XIII World Congress of Psychiatry

September 14, 2005

Cairo, Egypt

rrawson@mednet.ucla.edu

www.uclaisap.org

mu efficacy and opiate addiction

Full agonist

-

Superagonist

-

fentanyl

morphine/heroin

hydromorphone

Positive

effect

Potentiallylethal dose

Agonist+partial agonist

Partialagonist

=

- buprenorphine

addictive

potential

Antagonist - naltrexone

dose

Negative

Antagonist + agonist/partial agonist

effect

Mu efficacy and opiate addiction
buprenorphine clinical pharmacology
Buprenorphine: Clinical Pharmacology

Partial Agonist

  • high safety profile/ceiling effect
  • low dependence

Tight Receptor Binding

  • long duration of action
  • slow onset mild abstinence
intensity of abstinence

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18

19 20 21 22

Intensity of abstinence

Buprenorphine

Morphine

60

50

40

30

20

10

0

Himmelsbach scores

Days after drug withdrawal

buprenorphine detoxification in community clinics
Buprenorphine detoxificationin community clinics

Buprenorphine : Very brief pharmacology

CTN Protocols 0001 & 0002

Buprenorphine vs clonidine:

Inpatient detoxification

Outpatient detoxification

Treatment success /Number needed to treat

Looking ahead:

Implementation: Successes and barriers

The rest of the world

the first ctn protocols
The First CTN Protocols
  • Short term inpatient detoxification
    • Buprenorphine/naloxone vs clonidine
    • (CTN 0001)
  • Short term outpatient detoxification
    • Buprenorphine/naloxone vs clonidine
    • (CTN 0002)
study design
Study Design

Open Randomized Study

Bup/Nx:Clonidine = 2:1

Buprenorphine/Naloxone

13 days detoxification

Clonidine

13 days detoxification

joint probability

N remaining in treatment

X

N giving drug free urines

Total N of subjects

N remaining in treatment

Joint Probability
nnt number needed to treat
NNT: Number Needed to Treat

CTN 0001 (Inpatient)

  • NNT for Bup/Nx 77/59 = 1.31
  • NNT for Clonidine 36/8 = 4.5

NNT Clonidine : BupNx = 3.44

CTN 0002 (Outpatient)

  • NNT for Bup/Nx: 157/46 = 3.4
  • NNT for Clonidine: 74/4 = 18.5

NNT Clonidine : Bup/Nx = 5.44

NNT= Number of patients needed to treat to achieve 1 treatment success

buprenorphine what does it really mean
Buprenorphine: what does it really mean?
  • The great social experiment: return of opioid addiction treatment to medicine
  • Slow progress in implementation:
    • External barriers: legislative compromises
    • Inertia and resistance: medication and recovery
  • Application to the world and the region
pharmacotherapy and recovery
Pharmacotherapy and Recovery
  • Medications and recovery: incompatible?
  • “Medication is not recovery”
  • The great chemistry paradox
    • Addiction: chemistry went wrong
    • Role of “chemistry” (medicine) in recovery
slide21

Remember….

You Can Change the Brain with Either Biological or Behavioral Treatments

Alan Leshner

how people change
How People Change
  • “You can change some one’s life by altering his genes; but you can also do that by paying off his credit card”

James Watson

slide23

Thanks to

XIII Congress of Psychiatry: symposia organizing committee

National Institute on Drug Abuse

NIDA Clinical Trials Network Staff

CTN Publications Committee

Participating CTN Nodes and CTPs

Reckitt Benckiser: supplier of study med

Participating Patients

You the audience