Methadone and Driving

8/8/2019 Methadone and Driving

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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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NYSP

Methadone identified in 3.6% of all DUID cases in the last 3 years


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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

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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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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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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)

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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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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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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

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250

275

7 / 2 2

/ 2 0 0

8 / 1 6

/ 2 0 0

9 / 1 0

/ 2 0 0

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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

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/ 2 0 0

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/ 2 0 0

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2 0 0

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2 0 0

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/ 2 0 0

1 / 2 3

/ 2 0 0

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/ 2 0 0

3 / 1 4

/ 2 0 0

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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

Documents

Methadone and Driving