Buprenorphine in the
OTP, California
Judith Martin, MD, FASAM
Medical Director,
The 14th Street Clinic
www.14thstreetclinic.org
2004, COMP meeting
In a nutshell:
- DATA or 42CFR
-methadone or
buprenorphine
-specific adjustments
2004, COMP meeting
DATA 2000
Enables OBOT with sublingual
formulations of buprenorphine
Physician must qualify and notify
Medication prescribed or dispensed
Audited separately by DEA
Complaints go to medical board
30 patient limit for ‘group’.
2004, COMP meeting
Buprenorphine in OTP
Allowed under Federal Regs since 2003
Will be used in CA under Federal Regs
No 30 patient limit
OTP physician OK without new DEA
qualification
Dispensed only
Induction and observed dosing altered
2004, COMP meeting
CSAM suggests:
Until medication is covered by DrugMedi-cal, use under DATA 2000. The 42
CFT part 8 regs are overly restrictive for
this schedule 3 medication, more
flexible use under DATA 2000.
Only when patient limit becomes a
problem, consider regular OTP use.
2004, COMP meeting
Medication choice:
Methadone vs Suboxone
Full agonist:


Partial agonist
Easier induction
Less safety


Oral liquid


Observed dose easy
Computerized
dispensing easy
Cheaper
Tox screen easy
Induction tricky
Safe for takehome
Sublingual tablet
Observed dose takes
longer
 Manual pill counting
Expensive
Tox screen expensive

2004, COMP meeting
2004, COMP meeting
Buprenorphine is a Partial
Agonist
100
90
Full Agonist
(e.g. heroin)
80
70
60
Partial Agonist
(e.g. buprenorphine)
%
50
Mu Receptor
40
Intrinsic
Activity
30
20
10
0
Antagonist (e.g. naloxone)
no drug
low dose
DRUG DOSE
2004, COMP meeting
high dose
Differences in Precipitated
Syndromes
Buprenorphine will precipitate withdrawal only when it
displaces a full agonist off the mu receptors

Buprenorphine only partially activates the receptors, therefore a
net decrease in activation occurs and withdrawal develops
100
90
80
70
60
%
50
Mu Receptor
Intrinsic 40
Activity 30
20
10
0
Full Agonist (e.g. heroin)
A Net Decrease in Receptor Activity if
a Partial Agonist displaces Full Agonist
Partial Agonist (e.g. buprenorphine)
no drug
low dose
DRUG DOSE
high dose
2004, COMP meeting
Receptor Affinity
• AFFINITY is the strength with which a drug physically
binds to a receptor
 Buprenorphine’s affinity is very strong and it will displace full
agonists like heroin and methadone
 Note receptor binding strength (strong or weak), is NOT the
same as receptor activation (agonist or antagonist)
Mu
Receptor
Bup
affinity
is higher
Full
Agonist
Bound to Receptor
Therefore
Full Agonist is displaced
2004, COMP meeting
Receptor Dissociation
DISSOCIATION is the speed (slow or fast) of
disengagement or uncoupling of a drug from the
receptor


Buprenorphine’s dissociation is slow
Therefore Buprenorphine stays on the receptor a long time
and blocks heroin or methadone from binding
Mu
Receptor
Bup dissociation is slow
Therefore
Full Agonists can’t bind
2004, COMP meeting
Dose Response
Methadone Simulated 24 Hr. Dose/Response
At steady-state in tolerant patient
“Loaded”
“High”
mmt
bup
Normal Range
“Comfort Zone”
heroin Subjective
“Sick”
w/d
Objective w/d
0
hrs.
Time
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Opioid Agonist Treatment of Addiction - Payte - 1998
24
hrs.
Specific adjustments:
Patient selection
System to inform patients and answer
questions about buprenorphine, fees,
etc.
Easier to move from bup to methadone
than v.v. (ie, may want to use as first
line)
Pt has to taper to 30 of methadone to
transfer.
2004, COMP meeting
Specific adjustments:
DATA 2000 option
May set up separate billing and charts,
if DATA 2000 is used
Decision to order RX pads
Scheduling of doc and counselor time
Keep 30 patient census
May use nurses to do pill counts
May set up special fee structure.
2004, COMP meeting
Specific adjustments:
under OTP regs.
Induction timing becomes critical
What is observed dosing? May take up to 20
minutes, use waiting room more.
How to monitor compliance: urine test for bup
expensive, may do pill counts instead
May want to do MWF dosing
May ask for exception to daily observed
dosing in some cases.
Change DEA license to include schedule 3.
2004, COMP meeting
Useful websites:
CSAT physician locator by zip code:
http://buprenorphine.samhsa.gov/bwns_lo
cator/index.html
CSAM: www.csam-asam.org. Has forms
and handouts on website.
ASAM’s capwiz for info on 30 patient
limit bills pending. www.asam.org
2004, COMP meeting