buprenorphine and the nida ctn: research to practice walter ling & richard rawson isap/ucla xiii...
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Buprenorphine and the NIDA CTN: Research to Practice
Walter Ling & Richard Rawson ISAP/UCLA
XIII World Congress of PsychiatrySeptember 14, 2005
Cairo, Egypt
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Potentially lethal dosePositive effect
=
addictive
potential
Negative effect
Full agonist -morphine/heroin
hydromorphone
Antagonist - naltrexone
dose
Antagonist + agonist/partial agonist
Agonist + partial agonist
Super agonist -fentanyl
Partial agonist - buprenorphine
Mu efficacy and opiate addictionMu efficacy and opiate addiction
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Buprenorphine: Clinical Pharmacology
Partial Agonist• high safety profile/ceiling effect• low dependence
Tight Receptor Binding• long duration of action• slow onset mild abstinence
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Good Effect
0
20
40
60
80
100
p 0.5 2 8 16 32
Buprenorphine (mg)
Pea
k S
core
3.75 15 60
Methadone (mg)
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Respiration
02468
1012141618
p 1 2 4 8 16 32
Buprenorphine (mg)
Bre
ath
s/m
inu
te
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Intensity of abstinence
60
50
40
30
20
10
0
Him
mel
sbac
h s
core
s
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
Buprenorphine
Morphine
Days after drug withdrawal
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Buprenorphine detoxificationin community clinics
Buprenorphine : Very brief pharmacologyCTN Protocols 0001 & 0002Buprenorphine vs clonidine:
Inpatient detoxificationOutpatient detoxificationTreatment success /Number needed to treat
Looking ahead:Implementation: Successes and barriers
The rest of the world
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The First CTN Protocols
• Short term inpatient detoxification– Buprenorphine/naloxone vs clonidine– (CTN 0001)
• Short term outpatient detoxification– Buprenorphine/naloxone vs clonidine– (CTN 0002)
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Study Design
Buprenorphine/Naloxone13 days detoxification
Open Randomized StudyBup/Nx:Clonidine = 2:1
Clonidine13 days detoxification
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Joint Probability
N remaining in treatment
X
Total N of subjects
N giving drug free urines
N remaining in treatment
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Demographics 0001 (Inpatient)Bup/Nx Clonidine Total
Sex No. (%)
Male
Female
47 (61)
30 (39)
21 (58)
15 (42)
68 (60)
45 (40)Race No. (%)
White
Black
Hispanic
Other
43 (56)
15 (19)
12 (16)
7 (9)
20 (56)
7 (19)
6 (17)
3 (8)
63 (56)
22 (19)
18 (16)
10 (9)
Age in Years: Mean(Range 21-61)
35.6 37.4 -
Employment % (full/part time) - - 66
Mean Education in Years (SD) - - 12.8 (1.7)
Mean Years of Heroin Use (SD) - - 6.6 (8.1)
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Present and Clean0001 (Inpatient)
Present and Opiate Clean
Bup/Nx % Clonidine %
N 77 36
Day 3 or 4 52 67.5 16 44.4
Day 7 or 8 63 81.8 13 36.1
Day 10 or 11 56 72.7 10 27.8
Day 13 or 14 59 76.6 8 22.2
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Percent Present and Clean0001 (Inpatient)
0
10
20
30
40
50
60
70
80
90
100
Day 3 or 4 Day 7 or 8 Day 10 or 11 Day 13 or 14
ClonidineBup/Nx
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Demographics 0002 (Outpatient)Bup/Nx Clonidine Total
Sex No. (%)
Male
Female
115 (73)
42 (27)
51 (69))
23 (31)
166 (72)
65 (28)
Race No. (%)
White
Black
Hispanic
Other
62 (40)
57 (36)
33 (21)
5 (3)
30 (40)
28 (38)
13 (18)
3 (4)
92 (40)
85 (37)
46 (20)
8 (3)
Age in Years: Mean(Range 21-61)
38.3 40.0 -
Employment % (full/part time) - - 56.8
Mean Education in Years (SD) - - 12.4 (2.1)
Mean Years of Heroin Use (SD) - - 9.42 (9.6)
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Present and Clean0002 (Outpatient)
Present and Opiate Clean
Bup/Nx % Clonidine %
N 157 74
Day 3 or 4 37 23.6 5 6.8
Day 7 or 8 56 35.7 6 8.1
Day 10 or 11 52 33.1 5 6.8
Day 13 or 14 46 29.3 4 5.4
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Percent Present and Clean0002 (Outpatient)
0
5
10
15
20
25
30
35
40
45
50
Day 3 or 4 Day 7 or 8 Day 10 or 11 Day 13 or 14
ClonidineBup/Nx
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NNT: Number Needed to TreatCTN 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
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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
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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
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You Can Change the Brain with You Can Change the Brain with Either Biological or Behavioral Either Biological or Behavioral
TreatmentsTreatments
Remember….Remember….
Alan Leshner
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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
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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