Cannabis in the Workplace

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1 Cannabis in the Workplace Ryan Vandrey, PhD Johns Hopkins University School of Medicine

2 Disclosures Paid consultant to Zynerba Pharmaceuticals, Battelle Memorial Institute None of my consulting is directly related to the work I will present Funding for the studies provided by the Substance Abuse and Mental Health Services Administration (SAMHSA)

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4 Current State Laws

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6 Workplace Implications What are the effects of cannabis? What kind of impairment can be expected? How can we detect cannabis use? Does product type or route impact effects? Is there a biomarker for impairment? What about secondhand exposure? Can/should you test for legal cannabis use? What about treatment for problematic use?

7 Acute Effects Positive: Euphoria, relaxed, easier to laugh, increased appetite, potential medical benefit Negative: rapid heart rate, dry mouth, red and irritated eyes, paranoia, anxiety, nausea/vomiting, hallucinations, cognitive impairment (memory, attention, time estimation, complex cognition) Driving impairment: increased risk for accident, impairment on vehicle following, lane position, and emergency maneuvers

8 Chronic Use Effects Cannabis Use Disorder; tolerance/withdrawal Increased rate of mental health problems Decreased memory, attention, IQ Cannabinoid Hyperemesis Syndrome Altered brain structure; Age of onset important Unclear if effects are reversed with abstinence Correlations only; cannot infer causality Functional significance not well established; difficult to determine fit for duty impact

9 Cannabis and the Workplace 62% of the workforce in the U.S. lives in a state where medical use of cannabis is legal 21% of the workforce in the U.S. lives in a state where adult non-medical use of cannabis is legal Rates of use are higher in states where cannabis is legal versus those where it is not

10 Incident Treatment Admissions Approximately 21% of U.S. adults 18 and older entering substance treatment for the first time reported their employment status as full-time (FT) on the 2012 Treatment Episode Dataset (TEDS). Marijuana Percentage of FT workers who indicated their primary drug at admission was 17.2% 21% Prescription drugs 12.2% Illicit drugs 9.5%

11 Federal Guidelines SAMHSA Mandatory Guidelines for workplace drug testing Living document outlining regulations for workplace drug testing SAMHSA Division of Workplace Programs Current cannabis test standard: EIA screen: 50ng/mL GC/MS confirmation: 15 ng/ml Oral fluid and hair testing in development

12 SAMHSA Research Primary interest in PK to inform federal workplace drug testing Incorporated subjective, cardiovascular, performance assessments Enrolled non-tolerant healthy adults Varied route of administration and dose Same protocol across studies Evaluation of sex differences Ensuring consistent/complete dose delivery

13 Dosing Cannabis obtained from NIDA Passive, vaporized, ingested, smoked PL, 10mg, 25mg, and 50mg* doses * Oral administration only

14 Assessments 2 14

15 Biological Specimens Whole blood: THC, 11-OH-THC, and THCCOOH (LOQ = 0.5ng/mL) Urine: THCCOOH (LOQ = 0.75ng/mL) Saliva/oral fluid: THC and THCCOOH (LOQ = 2 and 0.02 ng/ml respectively)

16 Passive Exposure Study 3 test sessions; 12 participants per session 5.3% THC cannabis; no ventilation 11% THC cannabis; no ventilation 11% THC cannabis; ventilation 6 smokers (ad-lib) and 6 passively exposed 60-minute exposure period

17 Test Chamber

18 Effect of Ventilation

19 Can I Get a Contact High?

20 Can I Get a Contact High?

21 PK/PD Summary Urine: Cmax, 2-11 hrs; >15 ng/ml, 2-30 hrs OF: Cmax = 0.25 hr; > 4 ng/ml, hrs Blood: Cmax = hrs; Two > 5 ng/ml Room ventilation has a significant impact on secondhand smoke exposure Under extreme circumstances, intoxication and positive drug tests can occur Likelihood of positive test depends on the biological matrix and cut-offs used

22 Oral Administration Study 1: Pharmacokinetic Emphasis - 3 doses of cannabis - Between subjects design - Assessments over 9 days (PD on Day 1) Study 2: Pharmacodynamic Emphasis - 3 doses plus placebo - Within-subjects crossover design - PK/PD for 8 hours post-administration

23 Study 1 Methods 18 healthy adults recruited - Prior cannabis use; not in past 3 months 6-days residential; 3-days outpatient Single dose of cannabis administered Day 1 - Whole plant cannabis baked into brownies with 10, 25, or 50mg THC - 3M/3F administered each dose Standard low-fat breakfast provided

24 Drug Preparation Cannabis ground into powder Heated for 30 min at 250 F (121 C) Individual doses stirred into brownie batter and baked for 30 min at 325 F (163 C)

25 ng/ml Urine PK Oral Cannabis, THCCOOH, Urine THCCOOH Mean UR, 10 mg THCCOOH Mean UR, 25 mg THCCOOH Mean UR, 50 mg 15 ng/ml Cutoff Hours 25

26 ng/ml Hours Urine PK UR Cmax, Oral Cannabis (THCCOOH) 10 mg 25 mg 50 mg 200 UR Detection Times, Last Positive 15 ng/ml, Oral Cannabis (THCCOOH) 10 mg 25 mg 50 mg Mean Subjects Dosed Mean Subjects Dosed 26

27 ng/ml Oral Fluid THC Oral Cannabis, THC, Oral Fluid THC Mean OF 10 mg THC Mean OF 25 mg THC Mean OF 50 mg Hours 27

28 pg/ml Oral Fluid THCCOOH Oral Cannabis, THCCOOH, Oral Fluid THCCOOH Mean OF 10 mg THCCOOH Mean OF 25 mg THCCOOH Mean OF 50 mg 50 pg/ml Cutoff Hours 28

29 ng/ml Whole Blood THC 3 Oral Cannabis, THC, Blood THC Mean BL, 10 mg THC Mean BL, 25 mg THC Mean BL, 50 mg 2 ng/ml Cutoff Hours 29

30 Whole Blood 11-OH-THC Oral Cannabis, 11-OH-THC, Blood ng/ml OH THC Mean BL, 10 mg 11-OH THC Mean BL, 25 mg 11-OH THC Mean BL, 50 mg Hours

31 ng/ml Whole Blood THCCOOH Oral Cannabis, THCCOOH, Blood THCCOOH Mean BL, 10 mg THCCOOH Mean BL, 25 mg THCCOOH Mean BL, 50 mg Hours 31

32 Oral Administration THC = Passive THC = Smokers at baseline Drug Effect much greater

33 Oral PK Summary URINE Long detection times for THCCOOH ORAL FLUID Short detection times for THC THCCOOH was erratic BLOOD Very low cannabinoid concentrations 2/6 at 50 mg THC dose had 5 ng/ml peak 2/6 at 10 mg did not have detectable THC Moderate correlation with VAS Drug Effect, but not performance impairment

34 Study 2 Methods 17 healthy adults (9M, 8F) - Prior cannabis use; not in past month - No cannabis use between sessions 4 outpatient sessions; 1 week between Within-subjects crossover design - 10, 25, and 50mg THC doses - Placebo = 250mg cannabis < 1% THC Standard low-fat breakfast provided

35 VAS: Drug Effect * * *

36 VAS: Good Effect * * *

37 VAS: Unpleasant Effect * *

38 Other Subjective Effects Increased ratings of Tired/Sleepy, Heart Racing, Nervous/Anxious, Hungry/Have Munchies; Decreased rating of Alert following 25 and 50mg doses Increased ratings of Paranoid, Irritable, Sick and Restless at 50mg dose

39 Heart Rate * *

40 DSST: # Correct * *

41 PASAT: # Correct * *

42 Div Attention: Tracking * *

43 PK/PD Correlations

44 PK/PD Correlations

45 Oral PD Summary Orderly dose effects observed across pharmacodynamic measures 25mg and 50mg THC doses consistently different from placebo; subjective intoxication and performance impairment evident 10mg THC dose generally not different from placebo on negative effects Greater drug effects for females on select outcomes

46 Smoke Vs. Vapor 17 healthy adults (9M, 8F) - Prior cannabis use; not in past month - No cannabis use between sessions 6 outpatient sessions; 1 week between Within-subjects crossover design - PL, 10, and 25mg THC doses - Clustered by route, counterbalanced - Random order within route Standard low-fat breakfast provided

47 Drug Administration Smoked: exact dose of cannabis placed in pipe; covered; participants instructed to smoke entire contents ad-lib; checked for completion by pharmacist Vaporized: exact dose of cannabis placed in Volcano vaporizer; Temp set to 400 F (204 C); opaque bag covered balloon ; participant inhaled 3 balloons ad-lib

48 VAS: Drug Effect Smoked Smoke PL Smoke 10mg Vaporized Vape PL Vape 10mg 70 Smoke 25mg 70 Vape 25mg Hours Hours

49 VAS: Good Effect Smoked Smoke PL Vaporized Vape PL 80 Smoke 10mg 80 Vape 10mg 70 Smoke 25mg 70 Vape 25mg Hours Hours

50 VAS: Unpleasant Effect Smoked Smoke PL Smoke 10mg Vaporized Vape PL Vape 10mg 70 Smoke 25mg 70 Vape 25mg Hours Hours

51 Heart Rate Smoked Smoke PL Vaporized Vape PL 90 Smoke 10mg Smoke 25mg 90 Vape 10mg Vape 25mg Hours Hours

52 DSST: # Correct Smoked Vaporized Smoke PL Smoke 10mg Smoke 25mg Vape PL Vape 10mg Vape 25mg Hours Hours

53 PASAT: # Correct 90 Smoked 90 Vaporized Smoke PL Vape PL 65 Smoke 10mg 65 Vape 10mg Smoke 25mg Vape 25mg Hours Hours

54 Div Attention: Tracking Smoked Smoke PL Smoke 10mg Smoke 25mg Vaporized Vape PL Vape 10mg Vape 25mg Hours Hours

55 ng/ml Blood THC mg smoke 25mg smoke 10mg vape 25mg vape BL Hours

56 ng/ml Oral Fluid THC mg smoke 25mg smoke 10mg vape 25mg vape BL Hours * THCCOOH less than 0.01ng/mL for all samples

57 Smoke/Vape Summary Orderly dose effects observed Vaporization produced greater THC exposure and was associated with higher drug effects Blood biomarkers decreased rapidly and returned to baseline before drug effects

58 Comparison of Outcomes by Route of Administration

59 Beats Per Minute Δ from Baseline Heart Rate mg THC Smoke Vaporized Oral * * mg THC Smoke Vaporized Oral * * * BL BL Time (Hours)

60 VAS (mm) Δ from Baseline Drug Effect 10 mg THC 25 mg THC Smoke Vaporized Oral * * * Smoke Vaporized Oral * * * BL BL Time (Hours)

61 Avg. Distance from Target Divided Attention mg THC Smoke Vaporized Oral * mg THC Smoke Vaporized Oral * * BL BL Time (Hours)

62 Number Correct Δ from Baseline PASAT 10 mg THC 25 mg THC Smoke Vaporized Oral * Smoke Vaporized Oral BL BL Time (Hours)

63 Number Correct Δ from Baseline DSST 10 mg THC 25 mg THC Smoke Vaporized Oral BL * Smoke Vaporized Oral* BL * Time (Hours)

64 Blood THC (ng/ml) Blood THC + Drug Effect 25mg THC Dose Smoke Vape Oral BL Hours Post Dosing Hours Post Dosing

65 Blood 11-OH-THC (ng/ml) Blood 11-OH-THC (25mg) 5 4 Smoke Vape Oral BL Hours Post Dosing

66 Blood THCCOOH (ng/ml) Blood THCCOOH (25mg) Smoke Vape Oral BL Hours Post Dosing

67 Oral Fluid THC (ng/ml) Oral Fluid THC (25mg) Smoke Vape Oral BL Hours Post Dosing

68 PK/PD Correlations

69 Comparative Summary Type and magnitude of effects similar, but vaporized > oral and smoked Same individuals showed comparable likelihood for adverse effects across - Adverse events included nausea/vomiting, dizziness, anxiety/paranoia, and dry mouth Different time course for oral vs inhaled; cardiovascular vs subjective vs performance; frequent users vs infrequent-users

70 Testing Issues Window of detection in urine exceeds drug effects and increases with frequency of use Can t reliably differentiate acute use from residual cannabinoids in frequent users No biomarker that predicts impairment Employers in most states can still restrict employment based on drug testing Maine law now negates this

71 Treatment of CUD Subset of cannabis users develop problems Same types of problems as other drugs Extreme difficulty in quitting Effective treatments available Most community clinics/providers have programs

72 Limitations Only infrequent cannabis users enrolled Assessed the low end of doses Only one type of cannabis (high THC, low CBD) studied Other routes of administration and product types still need to be evaluated (transdermal, suppository, oils/concentrates, etc.)

73 Summary Cannabis testing and policy is incredibly complex No good way to determine time of last use or impairment except when use was very recent Big differences by route of administration Tolerance is a factor Future studies will explore other product types and novel methods of determining impairment

74 Thanks!! Collaborators: Ed Cone, Evan Herrmann, Nick Schlienz, George Bigelow, John Mitchell, Ron Flegel, Charlie LoDico, Eugene Hayes NIDA Drug Supply Program Johns Hopkins ICTR Heroic efforts of support staff and my family Contact Info:

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