Interpretation of Drug Testing Results in Medication-Assisted … · 2019-02-05 · Interpretation...

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Interpretation of Drug Testing Results in

Medication-Assisted Treatment

©NCDC, April 2018The following presentation may not be copied in whole or in part without the written permission of the author of the National Drug Court Institute.

Written permission will generally be given upon request.

Developed by: Paul L. Cary M.S.

National Center for DWI Courts

WHAT DOES THIS DRUG TEST RESULT MEAN?

Does the use of MAT drugs in

an effort to promote recovery

complicate the interpretation of

drug testing results?

TYPES OF DRUG TESTS

On-site devices (“instant”, “rapid”, POCT – “point of care testing”)

Dozens and dozens of individual products

Lab-based/Court-based immunoassay screening instruments

Lab-based confirmationGC/MS

LC/MS/MS

NOT ALL DRUG TESTS ARE CREATE EQUAL

Selectivity of a drug testChemical properties of the test that determine the degree to which drugs will react to (bind) to that test

Test A – Opiates (300 ng/mL cutoff)Urine sample that contains oxycodone at 500 ng/mL will test positive

Test B – Opiates (300 ng/mL cutoff)Urine sample that contains oxycodone at 500 ng/mL will test negative

Test A for Opiates – has a greater affinity for oxycodone than Test B

TWO-STEP TESTING APPROACH

Screening Test(Usually immunoassay tests) Designed to

separate negative samples from samples

that are “presumptively positive”

Confirmation Test(GC/MS, LC/MS) Follow-up procedure

designed to validate positive test results

Why can’t you adjudicate based on the screening

test results? FALSE POSITIVES

DRUG TESTS AND CROSS REACTIVITY

Screening tests can and do react to “non-target compounds”

• Amphetamines

• Benzodiazepines

Obtain list of interfering compounds from lab or on-site

vendor

Study results have demonstrated accuracy rates for initial

screening tests as low as 70%

Confirm positive results – BEST PRACTICE!

TYPICAL CUTOFF LEVELS

Amphetamines * 500 ng/mL 250 ng/mL

Benzodiazepines 300 ng/mL variable

Cannabinoids * 20/50 ng/mL 15 ng/mL

Cocaine (crack)* 150 ng/mL 100 ng/mL

Opiates (heroin) * 300/2000 ng/mL variable

Phencyclidine (PCP) * 25 ng/mL 25 ng/mL

Alcohol 20 mg/dL 10 mg/dL

SAMHSA (formerly NIDA) drugs

Screening Confirmation

WHAT IS A CUTOFF LEVEL?

Cutoffs are not designed to frustrate treatment professionals or court practitioners

A drug concentration, administratively established for a drug test that allows the test to distinguish between negative and positive sample - Threshold

Cutoffs provide important safeguardsScientific purposes (detection accuracy)Legal protections (evidentiary admissibility)

Measured in ng/ml = ppb

CUTOFFS AND FALSE POSITIVES

As you lower the cutoff level of a drug test

You increase the potential for false positive test results

How Do “Screening” Drug Tests

Work?

DRUG TESTS AND CROSS REACTIVITY

Drug Test Drug

Same principle applies to how drugs produce a response in the brain.

DRUG TESTS AND CROSS REACTIVITY

opiates fit = positive test

methadone doesn’t fit = negative test

Immunoassay screening tests

opiates antibody

DRUG TESTS AND CROSS REACTIVITY

morphine 100%

codeine 200%

heroin 80%

hydrocodone 75%

hydromorphone 45%

oxycodone 20%

DRUG TESTS AND CROSS REACTIVITY

(300 ng/mL opiate cutoff test)

150 ng/mL codeine

1500 ng/mL oxycodone

+

+

If oxycodone is a major substance of abuse in your

jurisdiction, you should consider a separate drug test for oxycodone as part of your

initial screening analysis.

NEGATIVE OR NONE DETECTED RESULTS

Client is remaining abstinent or not using a

drug that can be detected by the test.

Other possible explanations

Client not using enough drug

Client’s drug use is too infrequent

Collection too long after drug use episode

Sample has been tampered

Test being used not sensitive enough

Client using drug not on testing list

NEGATIVE OR NONE DETECTED RESULTS

Indicates that no drugs or breakdown products (metabolites), tested for, were detected in the sample tested

No such thing as “zero” tolerance or “drug free”

Negative does not mean NO drugs present

NEGATIVE = NONE DETECTED INTERPRETATION

NO need to second-guess every negativeresult

Not suggesting withholding positive reinforcement and rewards for positive behaviors

Drug testing is a monitoring tool

Assess none detected drug testing results in the context of your client’s overall program compliance (or non-compliance) and their life’s skills success (or lack thereof)

POSITIVE TEST RESULT INTERPRETATION

Indicates that drug(s) or breakdown products (metabolites), tested for, were detected in the sample tested

Drug presence is above the cutoff level

Greatest confidence achieved with confirmation

Result

Interpretation

for MAT Drugs

MEDICATION-ASSISTED TREATMENT

Medication-Assisted Treatment (MAT) is a

form of pharmacotherapy and refers to any

treatment for a substance use disorder that

includes a pharmacologic intervention as part

of a comprehensive substance abuse

treatment plan with an ultimate goal of

participant recovery with full social function.

MAT DRUGS

Medications for Alcohol DependenceNaltrexone: (ReVia®, Vivitrol®, Depade ®)

Disulfiram: (Antabuse®)

Acamprosate: (Campral®)

Medications for Opioid DependenceMethadone

Buprenorphine: (Suboxone® and Subutex®)

Naltrexone: (ReVia®, Vivitrol®, Depade ®)

WHAT IS NALTREXONE?

Belongs to a class of drugs known as opiate antagonists

Block the brain’s neurotransmitters

Displaces opiates from their binding site

Diminishes physical effects of opiates

Will naltrexone test positive on an opiate drug test?

Neuron Transmission

synapse

Credit Dennis Wei

Credit Dennis Wei

NEURAL SURFACE MEMBRANE

Ligand could be heroin, morphine, oxycodone or a MAT drug

LIGAND (MAT DRUG) BINDS TO RECEPTOR

MAT Drug (naltrexone)

Opiate Drug

Credit Dennis Wei

Do MAT drugs bind to immunoassay drug tests to produce “false positives”?

opiates fit = positive test

Does naltrexone “fit” and produce a “false positive” result?

Immunoassay screening tests

opiates antibody

Ethanol

SIEMENS EMIT ASSAY CROSS-REACTIVITY DATA

= 1,000,000 ng/mL

Abstract: A clinical evaluation of the naltrexone, a biodegradable sustained-release dosage was carried out in 4 healthy normal males.

Subjects were given an intravenous dose of 10 mg naltrexone and approximately 1 week later a 63-mg dose of naltrexone by subcutaneous administration.

Urine levels for naltrexone were 79-215 ng/mL.

MAT DRUGS

Medications for Alcohol DependenceNaltrexone: False Positive with Opiate Assay – NO!

Disulfiram: (Antabuse®)

Acamprosate: (Campral®)

Medications for Opioid DependenceMethadone

Buprenorphine: (Suboxone® and Subutex®)

Naltrexone: False Positive with Opiate Assay – NO!

OPIATES – RESULTS INTERPRETATION

All opiates are narcotic analgesics

Relieve pain and controlled substances

Not all narcotic analgesics are opiatesMeperidine (Demerol®)

Propoxyphene (Darvon®)

Methadone

Pentazocine (Talwin®)

Fentanyl (Sublimaze®)

Buprenorphine: (Suboxone®)

Naltrexone: (ReVia®, Vivitrol®, Depade ®)

Siemens Negative Reactivity Data

Thermo-Fisher Negative Reactivity Data

= 1,000,000 ng/mL

Siemens Negative Reactivity Data

Thermo-Fisher Negative Reactivity Data

= 100,000 ng/mL

MAT DRUGS

Medications for Alcohol DependenceNaltrexone: False Positive with Opiate Assay – NO!

Disulfiram: (Antabuse®)

Acamprosate: (Campral®)

Medications for Opioid DependenceMethadone: NO! with Opiate Assay

Buprenorphine: NO! with Opiate Assay

Naltrexone: False Positive with Opiate Assay – NO!

MAT DRUGS

Medications for Alcohol DependenceNaltrexone: False Positive with Opiate Assay – NO!

Disulfiram: NO! with drug tests reviewed

Acamprosate: NO! with drug tests reviewed

Medications for Opioid DependenceMethadone: NO! with Opiate Assay

Buprenorphine: NO! with Opiate Assay

Naltrexone: False Positive with Opiate Assay – NO!

CONCLUSIONS

Using standard instrument-based screening immunoassay drugs tests (in-lab or in-court), MAT drugs do not cross-react to produce “false positive” results.

When using on-site testing devices the cross-reactivity toward MAT drugs is largely unstudied. Contact product vendor.

Confirmation testing (GC/MS or LC/MS) resolves all cross-reactivity issues

CONFIRMATION: BEST PRACTICE

Gas Chromatography-mass Spectrometry (GC/MS) or (LC/MS)

Drug molecules separated by physical characteristicsIdentified based on chemical “finger-print”Considered Gold Standard

Refer to NADCP Adult Drug Court Best Practice Standards – Volume II

NO SUBSTITUTE FOR KNOWLEDGE AND EXPERTISE

Unethical to adjudicate based upon misinformation -violation of due process

Develop a relationship with your laboratory

Develop a relationship with your on-site device vendor

Don’t be afraid to “call the company”

Seek expert advice

CONFIRM – positive results!

Email Address:

carypl@health.missouri.edu

About this Project

For More Information:

Website: www.ndcrc.org

This project was supported by Grant No. G1299ONDCP02A awarded by the Office of National Drug Control Policy, Executive Office of the President. Points of view or

opinions in this document are those of the authors and do not represent the official position or policies of the Executive office of the President.