Four Key Issues for Court-Directed Drug Testing By: Paul L. Cary Toxicology Laboratory University of Missouri

The law is not black and white and neither is science. “. . there is a substantial gap between the questions that the legal community would like to have answered by drug testing and the answers that the scientific community is able to provide. The real danger lies in the legal community’s failure to “mind the gap” by drawing unwarranted inferences from drug testing results.”

Four Key Issues interpreting urine drug testing results eliminating the use of urine drug levels in court proceedings establishing a pragmatic cannabinoid detection window monitoring alcohol abstinence using EtG determinations

Interpretation of Urine Drug Test Results

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 client is 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 urine is tampered test being used not sensitive enough client using drug not on testing list

Negative/None Detected Interpretation no need to second-guess every “negative” result not suggesting withholding positive reinforcement & 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 ALWAYS confirm positive results in original sample

What is a “cutoff” level ? a drug concentration, administratively established for a drug test that allows the test to distinguish between negative and positive sample - “threshold” cutoffs are not designed to frustrate CJ professionals cutoffs provide important safeguards: scientific purposes (detection accuracy) legal protections (evidentiary admissibility) measured in ng/mL = ppb

Typical Cutoff Levels screening & confirmation amphetamines * 1000 ng/mL 500 ng/mL benzodiazepines 300 ng/mL variable cannabinoids * 20 & 50 ng/mL 15 ng/mL cocaine (crack)* 300 ng/mL 150 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

No such thing as “zero tolerance” testing drug tests not capable of testing to “0” ng/mL each drug & each drug test has a limit of detection drug courts urged to utilize “standardized” cutoffs potential hazards of a “zero-tolerance” approach (use of non-traditional cutoffs) testing accuracy (increase in false-positives) court’s justification for abnormally low cutoffs can/will your laboratory “defend” low cutoffs increased challenges/scrutiny to positive results lowered cutoffs may include “inadvertent” exposures

Isn’t any amount of drug in a client’s system a violation? punishment model vs. therapeutic model drug testing results (which form the foundation for incentives & sanctions) need to be scientifically accurate & legally defensible protection of client rights & the court

Exceptional (lowered) cutoffs in an effort to “catch” covert client drug use: provides only a marginal increase in drug detection opens your court to increased scrutiny associated with potential false positives and resulting inappropriate sanctions it’s all about credibility it’s all about confidence

The Issue of Urine Drug Concentrations

Drug Tests are Qualitative screening/monitoring drug tests are designed to determine the presence or absence of drugs - NOT their concentration drug tests are NOT quantitative

Drug concentrations or levels associated with urine testing are, for the most part, USELESS ! cocaine metabolite 517 ng/mL opiates negative cannabinoids negative amphetamines negative

The Twins A B 200 mg Wonderbarb @ 8:00 AM Collect urine 8:00 PM 12 hours later A B

The Twins - urine drug test results A B Wonderbarb = 638 ng/mL Wonderbarb = 3172 ng/mL

The Twins - urine drug test results physiological make up exact amount drug consumed exact time of ingestion exact time between drug exposure and urine collection AND YET . . . . . A B

The Twins - urine drug test results Twin B’s urine drug level is 5 times higher than Twin A A B Wonderbarb = 638 ng/mL Wonderbarb = 3172 ng/mL

Are any of the following questions being asked in your court? How positive is he/she? Are his/her levels increasing or decreasing? Is that a high level? Is he/she almost negative? Is this level from new drug use or continued elimination from prior usage? What is his/her baseline THC level? Does that level indicate relapse? Why is his/her level not going down? (or up?)

THE ISSUE Urine drug concentrations are of little or no interpretative value. The utilization of urine drug test levels by drug courts generally produces interpretations that are inappropriate, factually unsupportable and without a scientific foundation. Worst of all for the court system, these urine drug level interpretations have no forensic merit.

Where do urine drug levels come from? lower drug level higher drug level 20 ng/mL The importance of witnessed collection (for urine monitoring) can not be over-emphasized. As indicated on the slide, urine collections which are not witnessed are of little or no assessment value because of the propensity of drug court participants not to provide a legitimate sample (denial; efforts to hide relapse). The definition of “witnessed collections” is direct line-of-sight observation – basically staring at a participants genitals. Difficult? - yes! Uncomfortable? - no doubt! Necessary? - absolutely critical. Put another way; if drug courts don’t directly observe urine collections, they should not waste their time and money on testing efforts! It’s THAT important! The success of monitoring depends on a legitimate specimen for testing. The most likely guarantor that a legitimate specimen will be produced is with direct-observation collections. Remember, a drug court can employ the absolute best testing methods available, but that testing is worthless if the sample has been tampered with (by the participant) prior to the testing process. NEGATIVE RESULT POSITIVE RESULT screening drug testing cutoff

Scientific Rationale Technical Issues Physiological testing not linear tests measure total drug concentrations Physiological variability of urine output differential elimination of drug components

“Expected Values: When the test is used as a qualitative assay, the amount of drugs and metabolites detected by the assay in any given specimen cannot be estimated. The assay results distinguish between positive and negative specimens only.”

THIS ? 432 indicates he going up, right? is 22 above the cutoff? does 219 mean new use? 307 – well she’s almost negative, correct? 639 is really high for THC, isn’t it? I think 1200 is a new record, isn’t it? 115 is down from yesterday, probably continued elimination? 515 is much higher than last week, right? don’t we need to consider relapse at 57?

OR THIS ? Negative or Positive

Advantages of Eliminating Drug Levels court decisions have a strong scientific basis & forensically sound no longer attempt to interpret data that is not interpretable greater confidence in decision making process removes ambiguity associated with manipulating numbers that few in drug court are trained to do adds additional fairness/equity in sanctions & rewards process

Final Thought: However well-intentioned, the use of urine drug testing levels cannot be supported by the science and represents an adjudication practice that is not forensically defensible. An unambiguous and equitable evidentiary foundation that will pass both scientific and legal scrutiny is crucial to the continued success of drug courts (criminal justice).

The Cannabinoid Detection Window

Cannabinoid Detection in Urine Conventional wisdom has led to the common assumption that cannabinoids will remain detectable in urine for 30 days or longer following the use of marijuana. RESULT: delay of therapeutic intervention hindered timely use of judicial sanctioning fostered denial of marijuana usage by clients

Perpetuating 30-Plus Day Assumption Substance abuse treatment literature that proclaims, “some parts of the body still retain THC even after a couple of months”. Drug abuse information targeted toward teens “Traces of THC can be detected by standard urine and blood tests for about 2 days up to 11 weeks”. Health information websites that provide the following guidance; “At the confirmation level of 15 ng/ml, the frequent user will be positive for perhaps as long as 15 weeks.” And, last but not least Dr. Drew Pinsky (a.k.a. Dr. Drew) who has been the co-host on the popular call-in radio show "Loveline" for 17 years who states; “Pot stays in your body, stored in fat tissues, potentially your whole life.”

Cannabinoids - Recent/Relevant Research 30+ day detection window often exaggerates duration of detection window reasonable & pragmatic court guidance detection time: at 50 ng/mL cutoff up to 3 days for single event/occasional use up to 10 days for heavy chronic use detection time: at 20 ng/mL cutoff up to 7 days for single event/occasional use up to 21 days for heavy chronic use

Addressing Imperatives for Cannabinoids acknowledge research reporting prolonged THC elimination establish a reasonable and pragmatic detection window guidance for the vast majority of case adjudications sound judicial practice requires that court decisions be based upon case-specific information in unconventional situations that confound the court, qualified toxicological assistance should be sought

Recent Cannabinoid Use versus Non-recent use (double sanction issue): How do drug courts discriminate between new drug exposure and continued elimination from previous (chronic) use ? an issue only in first phase of program only drug that poses concern is cannabinoids “two negative test” rule – two back-to-back negative drug tests post clean out

Drug Court’s Competing Imperatives the need for rapid therapeutic intervention (sanctioning designed to produce behavioral change) the need to ensure that the evidentiary standards, crafted to protect client rights, are maintained

Ethyl Glucuronide (EtG) – New Strategy for Monitoring Alcohol Abstinence

Alcohol is the most commonly abused substance by drug court clients and the most difficult substance to detect in abstinence monitoring.

Ethyl Glucuronide

Advantages of Ethyl Glucuronide unique biological marker of alcohol use (no false positives) direct marker indicating recent use longer detection window than alcohol stable in stored specimens (non-volatile) is not formed by fermentation is not detected in the urine of abstinent subjects

Urine EtG Concentrations Following Alcohol Consumption: one 3.2% beer > 3800 ng/mL @ 4 hours detection up to 24 hours (alcohol - 90 minutes) three 3.2% beers detection up to 48 hours (alcohol - 3.5 hours)

Disadvantages of Ethyl Glucuronide testing available at relatively few laboratories testing somewhat costly ($25.00 price point) introduction of numerous testing approaches besides LC/MS/MS most significant concern – casual, inadvertent, environmental alcohol exposure causing positive results

On September 25, 2006 everything changed!

SAMHSA CSAT Advisory (9-25-06) “Currently, the use of an EtG test in determining abstinence lacks sufficient proven specificity for use as primary or sole evidence that an individual prohibited from drinking, in a criminal justice or a regulatory compliance context, has truly been drinking. Legal or disciplinary action based solely on a positive EtG, is inappropriate and scientifically unsupportable at this time. These tests should currently be considered as potential valuable clinical tools, but their use in forensic settings is premature.”

Sources of “Incidental” Alcohol Exposure medications (Nyquil) mouthwashes (Listermint & Cepacol) tincture of gingko biloba (herbal - memory) foods containing alcohol (such as vanilla extract, baked Alaska, cherries jubilee, etc.) “non-alcoholic” beers (O’Doul’s) colognes & body sprays insecticides (DEET) alcohol-based hand sanitizers (Purell)

What prompted SAMHSA Advisory ? the science of EtG testing - our capability to employ highly sensitive testing procedures to detect recent ethyl alcohol exposure - has outpaced our ability to appropriately interpret the test results in a forensically defensible manner consumption vs unintended exposure CSAT (National Advisory Council) concluded that there is inadequate research data about the populations being tested

Positive EtG Result (500 ng/mL): a result reported as EtG positive in excess of the 500 ng/mL cutoff is consistent with the recent ingestion of alcohol-containing products (1-2 days prior to specimen collection) by a monitored client studies examining “incidental” exposure widely conclude that results in excess of the 500 ng/mL cutoff are not associated with inadvertent or environment ethanol sources

Current State of EtG Testing my biggest concern is that this advisory will likely render ANY EtG result as legally inadmissible (for sanctioning purposes) already seen large decrease in EtG testing nationally EtG still valuable for therapeutic intervention

Options for Client Sanctioning positive urine EtG - cutoff of at least 500 ng/mL combined with: a client admission of use/replase identification of behavioral indicators alcohol-related arrest or incident alcohol-related job action client seen in bar/tavern a violation of EtG-specific contract

EtG- Specific Contract: outlines the behavioral requirements and compliance standards necessary for continued participation in drug court educate, alert and advise drug court clients of the potential (incidental) sources of alcohol that could produce a positive urine EtG test result listing the numerous commercial products that contain ethyl alcohol and provides a list of substances to avoid while in a drug court program

email address: carypl@health.missouri.edu