methadone and driving
TRANSCRIPT
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METHADONEAND
DRIVING
Laurel FarrellForensic [email protected]
mailto:[email protected]:[email protected] -
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Are people taking
methadone anddriving?
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Methadone prevalence in DUID cases
New Hampshire Dept of Safety
2007 Statistics
52 cases were positivefor MethadoneApproximately 3%
39 out of 52 highwayrelated; 4 MVA13 out of 52 OCME;3 fatal MVA
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Methadone prevalence in DUID cases
NYSP
Methadone identified in 3.6% of all DUID cases in the last 3 years
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Methadone prevalence in DUID cases
Georgia Bureau of Investigation
A 35% increase in the number of methadone identification in DUID cases - 8.7%+
A 130% increase in the number of methadone identifications in PM cases 9.7%+
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Methadone prevalence in DUID casesWisconsin State Laboratory of Hygiene
Methadone is the 7th
most frequently identified drugIncreased from 2 5 % of drug positive cases
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Methadone prevalence in DUID CasesSouthwestern Institute of Forensic Sciences
02468
10
12141618
1 9
8 9
1 9 9 0
1 9 9 1
1 9 9 2
1 9 9 3
1 9 9 4
1 9 9 5
1 9 9
6
1 9 9 7
1 9 9
8
1 9 9 9
2 0 0 0
2 0 0 1
2 0 0 2
2 0 0 3
2 0 0 4
2 0 0 5
2 0 0
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2 0 0 7
2 0 0
8 p
r o j e c t e
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Methadone Case Increase
WA State
050
100150200250300350
400450500
1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006
Drivers
Deaths
2006 - Methadone was detected in 7.4% of our 9789 cases.262 impaired drivers (5.4%) and 463 death investigation (10%) cases
The 5th
most frequently found drug other than ethanol in DUID cases
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2004 2005 SOFT/AAFS Survey of DRE LabsMost Frequently Encountered Drugs(no data from 3 labs; N = 39)
26
30
37
37
39
0 10 20 30 40
Methamphetamine
Hydrocodone
Cocaine
Benzodiazepines
Cannabis
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2004-2005 SOFT/AAFS Survey of DRE LabsMost Frequently Encountered Drugs(no data from 3 labs; N = 39)
4
5
8
5
10
6
12
16
26
28
0 5 10 15 20 25 30
Butalbital
Propoxyphene
PCP
MDMA
Zolpidem
Diphenhydramine
Methadone
Oxycodone
Carisoprodol/meprobamate
Morphine/Codeine
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History
Introduced into the United States in 1947 asan analgesic by Eli Lilly and Company1964 began use in Methadone MaintenanceTreatmentSince 2000 it has been increasinglyprescribed for pain management
Schedule II Controlled Substance Act
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Methadone Maintenance Therapy
1999 20% of the estimated 810,000 heroin addictsreceive MMT = 162,000MMT:
Individualized health careMedically prescribed opioidAdministered orally on a daily basisStrict program conditions and guidelines
The patient remains physically dependent on aopioid but is freed from the uncontrolled, compulsive
and disruptive behaviorImproved subject healthDecreased criminal activityIncreased employment
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U.S. Formulations
Oral Solutions10 mg of methadonehydrochloride per mL.Methadose Oral
ConcentrateCherry flavored liquidconcentrate.
Methadose Sugar-Free Oral Concentrate(methadone hydrochlorideUSP) is a dye-free, sugar-free, unflavored liquidconcentrate of methadonehydrochloride.
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U.S. Formulations
Tablets5 mg, 10 mgDolophine Hydrochloride
Diskets (dispersible tablet)40 mg methadose wafersformulated with insoluble excipients to deter the use of this drug by injection
Other:10mg/mL intensol
Intended to be diluted with at least 1 ounce of liquid10 mg/mL , 50 mg/1mL and 50 mg/2mL ampoulesLinctus - 2mg/5mL used in the UK for treating coughing interminal disease
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Current Methadone Use
32%
39%
24%
5%
2006 Distribution of Methadone
5 mg & 10 mg Tablets
(4,412,615 grams)Liquids (5,283,295grams)
40 mg Diskettes(3,236,405 grams)
All Others (665,224grams)
Includes Methadone Treatment Programs
Source: DEA ARCOS 04/2007
DEA Office of Diversion Control Methadone Mortality Working Group
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Current Methadone Use
DEA Office of Diversion Control Methadone Mortality Working Group
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Effects Analgesia - Pain relief Decreased Drug CravingRespiration depressedPupils constricted (miosis)ConstipationSubjective effects:
DrowsinessLight HeadedDizzinessHeadache
Suppressed cough reflex
Decreased appetiteSweatingReduced sex driveA variety of hormonalchanges
Low to
moderatedoses
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Effects
Slightly higher dosesEuphoriaMay experience restlessness and anxiety (dysphoria)
AgitationConfusion
DisorientationNausea and vomiting more common
Highest dosesUnconsciousnessDecreased body temperature and blood pressureConstricted pupils often used as an indicator of ODRespiration rate now dangerously low and is the cause of death in ODCardiac Conduction Effects
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Effects
Additive effects with other opioidsAdditive effects with Alcohol
Additive effects with CNS Depressants
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Current Methadone Use
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Current Methadone Use
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Methadone-Associated MortalityMethadone Mortality Working Group DEA Diversion; April 2007
Three Primary Scenarios:
1) Accumulation to toxic levels of methadoneduring the start of opioid treatment or painmanagement due to overestimation of toleranceand methadones long, often variable, half -life.2) Misuse of diverted methadone by individuals
with little or no opioid tolerance.3) Synergistic effects of methadone incombination with other CNS depressants(i.e., alcohol, benzodiazepines or other opioids).
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Miosis
Laboratory StudiesWeinhold and Bigelow, 1993
Methadone (50-60 mg p.o.).Peak miosis was best detected under moderately diminterior lighting 90 min after methadone
Higgins etal, Clin Phamacol Ther. 198520 mg methadone to 28 males beginning MMTMiosis observed in all subjectsProportional to reported heroin use and years since firstopiate use
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Opioid Receptors
1973 Discovery of opioid receptorsOpiate drugs work by mimickingnatural opiate-like molecules made andused in the brain.
1975 - Identified the first endogenous brainopioids, called endorphins.
Three major receptor subtypesMu (m)
mu1 analgesiamu2 respiratory depression
Kappa (k)
Delta (d)Principally found in the central nervoussystem and the gastrointestinal tract
www.biodavidson.edu
PET scan of opiatereceptors in humanbrain
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Euphoria Reinforcing Effect
Limbic systemMain regulator of emotionSurrounds the brain stem below the cerebral cortexOpiate receptors very dense
EuphoriaOpioids are not rapidly removed as endorphins areActivate receptors for extended periodsIncreases dopamine level in nucleus accumbens
Reinforcing effects seem to also be due to otherfactors not completely understood
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Pain
Incidence2006 National Center for Health Statistics Report
26% of Americans (76.5 million) over 20 years of age had pain
of any sort that persisted for more than 24 hoursPain affects more Americans than diabetes, heart diseaseand cancer combined.
Duration1999-2002 Study of people over 20 years of age
12% pain for 1-3 months14% pain for 3-12 months42% pain for more than one year
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Opioids vs Pain
Analgesia reducedsensitivity to painOpioids bring pain relief byinterfering with the painperception pathway in the
nervous systemSpinal cordInterfere with transmission of thepain messages between neurons -preventing them from reachingthe brainInterrupt the descending messagefrom the brain to the spinal cord
BrainEmotional and hormonal aspectsChanges the subjective messagereceived; still feel the pain but itno longer bothers you
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Tolerance
Chronic useLeads to changes in the nervous system
Develops quite rapidlyDoes not occur for all pharmacological effects
to the same extent or at the same rateNo or minimal tolerance to constipating effects ormiosis
Significant loss of tolerance may occur asquickly as three days without methadoneAfter 5 days the body has essentially eliminated thedrug and any drug intake should progress as if starting a dosing program
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Tolerance
Mechanisms responsible for toleranceIncreased rate of metabolism
Drug disposition toleranceAn increase in liver enzymes
Classical conditioning (effect of environmental cues)Changes in nerve cells
Adaptive mechanism to return the organism to homeostasisGradual increase in cell firing ratecAMP production increases to pre-opioid level
Example: 50 mg has proven fatal; 180mg/day in MMT; up to 780 mg/day in rare
instances
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Withdrawal
AnalgesiaRespiratory depressionEuphoriaRelaxation and sleepTranquilizationDecreased blood pressure
ConstipationPupil constrictionHypothermiaDrying of secretionsReduced sex driveFlushed and warm skin
Pain and irritabilityPanting and yawningDysphoria and depressionRestlessness and insomniaFearfulness and hostilityIncreased blood pressureDiarrheaPupil dilationHyperthermiaTearing, runny noseSpontaneous ejaculationChilliness and gooseflesh
Acute Action Withdrawal Sign
Psychopharmacology by Meyer and Quenzer
Symptoms generally develop more slowly and are lessacutely severe than those of morphine and heroinwithdrawal, but are usually more prolonged.
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Withdrawal
Rapeli et al, BMC Psychiatry, 2006, Feb 24;6:9Evaluated cognitive function during the first few weeksof abstinenceSubjects with opioid dependencePerformed significantly worse in tests measuringcomplex working memory, executive function, and fluidintelligenceCorrelation with days in withdrawal
Indicated a general deficit in higher order cognition
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Pharmacokinetics
The action of the body on the drugAbsorption, Distribution, Metabolism, and Elimination
Good Oral bioavailability = 36 99%Peak plasma levels 1-4 hours
Volume of distribution = 4-6.7 L/kgLong Half-Life 8-59 hoursMetabolism: liver
CYP450: 2B6, 2C19, 3A4 (primary), 2C9, 2D6 (minor)
Excretion: feces, urine
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Pharmacokinetics
Long Half-Life 8-59hours
Compared to morphineat avg of 3 hours
Good Oral bioavailability36-99%
Compared to morphine at20-40%
Large Volume of
Distribution
Due to its chemical structureAlmost as effective as IV
Large VD =distribution intotissues; lipid solubleLess reports of a rush effect
Allows the drug to be given once dailyMuch longer than the analgesiceffect, typically 6 8 hoursRisk of additional doses being consumedfor pain leading to respiratory
depression
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Pharmacokinetics
Metabolism: liver Enzymes - CYP450: 1A2, 2B6, 2C19,
3A4 (primary), 2C9, 2D6 (minor),
Drug-drug interactionsThese enzymes are used to metabolize large numbers of drugs3A4 approximately 2/3 of the PDR
Competitors two drugs using the same enzymeInhibitors = generally will reduce metabolism; increaseMethadone levels
Examples: Zithromax, Erythromycin, Sertraline,
Cimetidine, Prilosec, acute alcohol
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Pharmacokinetics
Metabolism: liverEnzymes - CYP450: 1A2, 2B6, 2C19,
3A4 (primary), 2C9, 2D6 (minor),
Drug-drug interactionsInducers = generally will result in more rapidmetabolism decreasing effects of Methadone
Examples: Phenytoin , St. Johns Wort,Carbamazepine, abstaining chronic alcoholic
Isoenzyme 2D6 is subject to genetic polymorphismRapid metabolizers and Slow metabolizers
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Pharmacokinetics
Excretion:feces, urine
Saliva, beast
milk, hair,amnioticfluid, nails
Primary metabolites:EDDP - inactiveEMDP - inactive
Minor metabolites:Methadol - activeNormethadol - active
Additional metaboliteshave been identified
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Blood Toxicology
Acute Oral Dosing (15-120 mg) 0.075 0.86 mg/L
Chronic Oral Dosing (100 - >200mg) 0.57 1.06 mg/L
DUI 0.05 0.64 mg/LMed Examiner 0.02 5.3 mg/L
Concentration ranges of subject groups overlapDetermination of impairment from bloodtoxicology alone is not possible
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POTENTIALDEFENSES IN
METHADONE DUID
CASES
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Defense:The impairment is not due to the Methadone butto the pain I am suffering
Scientific LiteraturePain deteriorated performance more than oralopioid treatment in cancer patients
Increase in reaction time correlated to painintensity and not opioid doseAbility to maintain lane position impaired inpain patients compared to controls
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Defense:The impairment is not due to the Methadone but tothe pain I am suffering
Documentation
DRE EvaluationDocument performance impairment at the time of drivingEvaluation questions: Are you sick or injured? andAre you under the care of a physician?
Comprehensive toxicologyDocumentation of prescribed drugs and no otherimpairing drugs
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Defense:The impairment is not due to the Methadone butto the other psychological disorders
Documentation
DRE EvaluationDocument performance impairment at the time of drivingEvaluation questions: Are you sick or injured? Areyou under the care of a physician? Do you have anyphysical defects?
Comprehensive toxicologyDocumentation of prescribed drugs and no otherimpairing drugs
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Defense:
In MMT and on a stable dose of Methadone
Scientific Literature
No significant performance decrements in laboratorytests:
Memory testVigilance and simple reaction timeVisual functioning
Compensatory, pursuit, and critical trackingNo decrement in maintaining lane position, speed andreaction time in a 75 minute driving simulator testLiterature Reviews that conclude that opioids do notimpair driving in the opioid-dependent person
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DocumentationDRE Evaluation
Document performance impairment at the time of drivingEvaluation questions: Are you under the care of a physician?
Methadone doseInquire how long the subject has been on the current doseScientific Literature
Impairment with 30%increase in doseScientific literature
Impaired psychomotor speed, decision making, inhibitorymechanisms, logical reasoning
Defense:In MMT and on a stable dose of Methadone
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DocumentationComprehensive toxicology
Documentation of no other drugs being
consumed
Defense:In MMT and on a stable dose of Methadone
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Methadone and Polydrug Use
Search for Methadoneonly cases:I put the request out to all 400+DREs and so far all methadonecases involved other drugs Dan Mulleneaux, Region Irepresentative to TAP
Not one of the cases came back Methadone alone NYSP Sgt.Doug Paquette Region III TAPRepresentative
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Methadone and Polydrug Use
2007 - 52 cases (3%) positiveBlood level ranges = 29-836 ng/ml73% males
18-81 y; Avg 38
27% females21-44 y; Avg 31
79% polydrug use19 (37%) w/Benzo17 (33%) w/Cannabis8 (15%) w/Cocaine8 (15%) w/Opioid
Polydrug use with methadone
4 drugs13% 1 Drug 21%
2 Drugs45%
3 Drugs21%
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Methadone and Polydrug Use in DWI CasesSouthwestern Institute of Forensic Sciences
13% 5%
19%
6%52%
14%
Benzos Only
Opiates Only
Methadone Only
COOH-THC Only
Combo Drugs
Contain CNSStimulants
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WA - High Prevalence of Other
Drugs (98% - drivers)
0.000
0.100
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0.500
0.600
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S o m a
A n t i - C
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Post Mortem
Drivers
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WA DRE Cases
Methadone only significant finding32 cases
Males 75%
Age 40 (mean) 42 (median)Methadone concentration:
0.26 mg/L mean 0.27 mg/L median42% involved in a MV collision
Most commonly involved collisions with parked cars45% arrested for erratic driving (significantweaving)
(1/3 of which were so bad, reported by cell phonecallers)
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WA DRE Cases
DRE Testing Results
Admissions: 78% Admitted using methadone31% Opiate Treatment Program34% Chronic Pain
Test
Walk and Turn
One Leg Stand
Romberg Balance
Time Estmate
Finger to Nose Generally Poor performance
Performance
5/8
3/4
Avg 2" sway
Widely Variable
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INDIVIDUAL
CASEEXAMPLES
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Pain Patient
35 year old maleCollided with vehicle in same lane of travel
Officers noted defendant sitting in hisvehicle nodding offRepeatedly asked the same questions
DRE noted slurred speech, watery eyesand droopy eyelids
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Pain Patient
Romberg Balance: 2-3 inches of swaySubject asked to repeat test (total 4)Estimated 30 secs as:
36, 45, 10, 76 seconds
Walk and Turn - 6/8 cluesLegs noticeably shaking
One Leg Stand 3/4Finger to Nose - 5/6
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Pain Patient
Admissions30 mg Methadone chronic pain3 hours before stop
Blood Toxicology: 0.27 mg/L methadoneEDDP, caffeine, nicotine
OutcomePhysician testified that methadone does not impairdrivingConvicted DUID
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Pez Dispenser
20 year old male, single vehicle accidentSubject claimed he slid off the road due tosnow and ice (Actual temp - 56 F.)Subject had thick, slurredspeech, staggered and had difficultystandingDescribed as on the nod
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Romberg Balance swayed 3 front to back and 2 side to side
Head tilted back so far he looked like a PezDispenser
Walk & Turn Stumbled during instructionstwice, missed heel to toe every step, stoppedafter the turn (8/8)
One-Leg-Stand repeatedly put his foot downand held onto wall for balance (4/4)
Finger to nose only touched his nose 1/6 (with
his knuckle) (6/6)
Pez Dispenser
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Pupil size:Room Light: 3.0 mm (within normal)Darkness: 3.0 mm (constricted)
Direct Light: 2.5 mm (within normal)Little to no reaction to lightPulse: 54, 56, 56 (normal = 60-90)BP: 128/68 (normal 120-140/60-90)Muscle Tone: Flaccid
Pez Dispenser
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AdmissionsUnknown amount of methadone
provided by a
friend
Blood Toxicology: 0.05 mg/L methadoneEDDP
Pleaded guilty to DUI Drugs
Pez Dispenser
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Implausible Deniability36 year old female, subject of multiple cellphone callers to 911Had struck a guardrail wiping out entire
right side of her carWeaving back and forth across multiplelanesDisoriented and unaware she had been
involved in a collisionDRE noted droopy eyelids, and constrictedpupilsSubject was very agitated
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Implausible Deniability
Romberg balance 2 circular sway andestimated 21 seconds to be 30Walk & Turn Unable to stand withoutsway, 10 steps up, 9 back, 8/8 clues (talkednon-stop)One-Leg-Stand swayed, hopped , put footdown, used arms 4/4Finger to nose 4/6
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Implausible Deniability
Pupil size:Room Light: 2.5 mm (within normal)Darkness: 3.0 mm (constricted)
Direct Light: 2.0 mm (within normal)Little to no reaction to light
Pulse: 92, 96, 96 (normal = 60-90)
BP: 156/108 (normal 120-140/60-90)Muscle Tone: Normal
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Implausible Deniability
AdmissionsMethadone at 7:30 am (15 hours prior to stop)
Opiate treatment program claimed no one at theclinic told her it would impair her
She continued to insist that she was not impaired
Blood Toxicology: 0.35 mg/L methadone
EDDP, caffeineConvicted of DUI Drugs
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Asleep at the Wheel
53 year old female, subject of a Drunk Driver to 911Witness:
Driver cut her off on a bridge
Pulled over - Still there 1.5 hours laterSlumped over the wheelCar still on and in drive
Initial officer:Difficulty keeping her eyes openSlurred SpeechHGN present; failed walk and turn
BrAC = 0.00%
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Asleep at the Wheel
Romberg balance 4 sway front to back and 3 sway side -to-side; estimated 34seconds to be 30
Walk & Turn Unable to stand withoutsway, missed heel-to-toe on almost allsteps, used arms for balanceOne-Leg-Stand swayed, put foot
down, used arms stopped for safety onboth legsFinger to nose missed touching herfingertip to nose on all six attempts
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Asleep at the WheelEyes - BloodshotHGN (immediate onset) and VGNPupil size:
Room Light: 4.5 mm (within normal)Darkness: 5.0 mm (within normal)Direct Light: 3.0 mm (within normal)
Little to no reaction to light
Pulse: 102, 98, 100 (elevated; normal = 60-90)BP: 114/82 (low; normal 120-140/60-90)Muscle Tone: Flaccid
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Asleep at the Wheel
AdmissionsOne 10 mg Methadone at 11:00 a.m. (7 hours prior)One 5 mg Klonopin at 4 or 5 p.m. (2-3 hrs prior)Got pills from another person
DRE Opinion: CNS Depressant
Toxicology: Urine
Positive Methadone & Quetiapine (Seroquel)Clonazepam was not detected in the urine
Elevated negative screen was not confirmed
Active DUID Case
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Common Poly
50 year old maleAuto AccidentStruck car waiting to make a left turn
Responding Officer:ShakingDroopy, Reddened EyesLethargic - Slow to answer questionsInitial SFSTs:
No HGN or VGNWalk and Turn Failed test; Body TremorsOne Leg Stand Discontinued for safety
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Common Poly
Romberg balance 2 circularsway, estimated 15 seconds to be 30, eyelidand body tremors
Walk & Turn Could not maintainbalance, missed heel-to-toe on almost allsteps, used arms for balanceOne-Leg-Stand swayed, put foot
down, used arms; leg tremorsFinger to nose missed touching fingertipto nose on all six attempts; eyelid and legtremors
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Common Poly
Eyes watery with reddened conjunctiva
Pupil size:Room Light: 2.5 mm (within normal)Darkness: 5.0 mm (within normal)Direct Light: 1.5 mm (constricted)
Normal reaction to light
Pulse: 96, 104, 100 (normal = 60-90)BP: 192/84 (normal 120-140/60-90)
Muscle Tone: Normal
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Common Poly
Admissions: Furosemide (Lasix)
Controlled Substance in car: Marijuana
DRE Opinion: Cannabis
Urine Toxicology:Methadone
7-aminoclonazepam
Active DUID Case
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Non-compliant MMT
32 yo, maleSubject leaves MMT clinic; ~10 mins. later hitsand kills a 69 year old male pedestrian who iscrossing street.Subject Statements:
Never saw the pedestrianHad placed a coffee between his legs and when helooked up the pedestrian was in his windshield
WitnessesComing from both directions could see pedestrian
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Non-compliant MMT
Day of Accident:No one notes anything unusual about subject;does not appear impairedSubject states that methadone does not have anyaffect on him and that he did not feel tired~7 hours after the crash subject is noticed fallingasleep in lobby at PDSubject states that he smoked pot about 1 weekagoSubjects attitude - very matter of fact showinglittle emotionSubject signs medical release forms
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Non-compliant MMT
Methadone Doses
5/1/2007
75
100
125
150
175
200
225
250
275
7 / 2 2
/ 2 0 0
8 / 1 6
/ 2 0 0
9 / 1 0
/ 2 0 0
1 0 / 5 /
2 0 0
1 0 / 3 0
/ 2 0 0
1 1 / 2 4
/ 2 0 0
1 2 / 1 9
/ 2 0 0
1 / 1 3
/ 2 0 0
2 / 7 / 2 0
0 6
3 / 4 / 2 0
0 6
3 / 2 9
/ 2 0 0
4 / 2 3
/ 2 0 0
5 / 1 8
/ 2 0 0
6 / 1 2
/ 2 0 0
7 / 7 / 2 0
0 6
8 / 1 / 2 0
0 6
8 / 2 6
/ 2 0 0
9 / 2 0
/ 2 0 0
1 0 / 1 5
/ 2 0 0
1 1 / 9 /
2 0 0
1 2 / 4 /
2 0 0
1 2 / 2 9
/ 2 0 0
1 / 2 3
/ 2 0 0
2 / 1 7
/ 2 0 0
3 / 1 4
/ 2 0 0
4 / 8 / 2 0
0
5 / 3 / 2 0
0
5 / 2 8
/ 2 0 0
6 / 2 2
/ 2 0 0
7 / 1 7
/ 2 0 0
D o s e
RED = Methadone dose when noncompliant
positive for additional drug
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Non-compliant MMT
Blood Toxicology:Alcohol - None Detected
Delta-9-THC = NegativeDelta-9-Carboxy-THC= 18 ng/mlMethadone = 754 ng/ml
Case Disposition Grand JuryTragic accident but no crime had beencommitted
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Summary of Case Examples
Impairment may occur in individuals undera doctors careLow dose in a nave individual can be
impairingPatients may not be properly informedMethadone patients may be non-compliantPolydrug use is commonMethadone in DUID prescribed forpain, MMT and through diversion
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In Conclusion
Methadone can impair performanceFactors that must be considered:
Reason for Use Pain, MMT, DiversionHealth of subjectHistory of Use a recent change?
TolerancePolydrug Use
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Impairment can not bedetermined by quantitative
blood toxicology alone.
Paired with the observationsof a DRE, a determination
of impairment can be made.
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Thank you
Toxicologists:Lisa Callahan, GADr. Michael Wagner, NH
Colleen Scarneo, NHDr. Jeanne Beno, NYJennifer Limoges, NYDr. Julia Pearson, VADr. Fiona Couper, WALaura Liddicoat, WIS
DREs:Dan Mulleneaux, AZSgt. Doug Paquette, NYSP
Sgt. Joe Reff, WatertownPD, NYAlan Bell, NiskayunaPD, NY