Clinical trial NCT03122691
Conditions: Behavioral Pharmacology of Cannabis
Sponsor: Johns Hopkins University
Start date: 2018-05-01; Completion date: 2020-02-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at different doses, on the ability to perform certain tasks such as balancing, eye tracking, and computerized measures of memory and attention, as well as performance on a novel app (DRUID) that is being developed for field sobriety testing. The investigators will collect biological fluids (urine, blood, saliva/spit) after cannabis is eaten or vaporized to see if there are markers in those fluids that can predict performance on the behavioral tasks and the DRUID App. The results of this study will help us better understand the effects of using cannabis, and to help identify behaviors and/or substances in the body that relate to cannabis impairment.

Detailed description:

Arms: arm 1: Single acute administration of placebo cannabis baked into a brownie arm 2: Single acute administration of cannabis containing 10mg THC baked into a brownie arm 3: Single acute administration of cannabis containing 25mg THC baked into a brownie arm 4: Single acute administration of placebo cannabis via commercial vaporizer arm 5: Single acute administration of placebo cannabis containing 5mg THC via commercial vaporizer arm 6: Single acute administration of placebo cannabis containing 20mg THC via commercial vaporizer
Interventions: intervention 1: cannabis
Intervention descriptions: intervention 1: Cannabis will be self-administered by study participants

Protocol documents:
Prot_SAP_000.pdf: 
 
Page 1 of 18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Differences in Cannabis Impairment and its Measurement Due to Route of Administration 
 
NCT03122691 
 
5/18/2018 
 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 2 of 18 
 
Johns Hopkins Medicine - eForm A 
 
 
 
• 
Use the section headings to write the eForm A, inserting the appropriate material in each. If 
a section is not applicable, leave heading in and insert N/A. 
• 
When submitting eForm A (new or revised), enter the date submitted to the field at the top 
of eForm A. 
 
*************************************************************************************************** 
 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
Over the past decade, there has been a paradigm shift in legal status and social perception of cannabis in 
the United States. Concurrent with the changing legal status of cannabis, rates of use and potency of 
available cannabis have increased, while perceived harm related to use has decreased. Not surprisingly, 
there has been a corresponding increase in prevalence of detecting delta-9-tetrahydrocannabinol (THC) in 
urine obtained from weekend nighttime drivers. While laws have been established for driving under the 
influence of drugs (DUID) across a range of drugs, current laws regarding cannabis impairment are either 
difficult to prosecute or are controversial, and vary widely across states.   
Effect-based laws are the most common and least controversial, but are the most difficult to prosecute. 
These laws often rely on testimony or evidence from the arresting officer or a drug recognition expert 
(DRE), as well as results from a blood or urine toxicology test, with no clear definition of what constitutes a 
positive determination of impairment. Per se laws are easier to prosecute because they explicitly define an 
analyte and a cut-off concentration for that analyte that determines impairment. However, per se laws are 
controversial because there is a lack of consistency about both which analyte the laws are based on (e.g., 
THC or one of its metabolites), and the appropriate cut-off concentration to determine impairment. Some 
states have enacted zero tolerance per se laws, but in states that have legalized cannabis use, zero 
tolerance laws for cannabis are not practical because common biomarkers of cannabis use can be 
detected days after a single use and do not correspond with periods of impairment. In fact, there is little 
scientific evidence from which to determine appropriate objective measures for identifying cases of 
cannabis impairment and DUID due to cannabis impaired driving. 
Currently most law enforcement use a combination of biological and behavioral assessments administered 
by DREs and blood THC levels to judge cases of suspected DUID involving cannabis. However, 
behavioral assessments have not been explicitly developed for detecting acute intoxication from cannabis, 
and blood THC levels do not necessarily correspond with acute impairment. THC blood levels can drop 
below cutoffs used for drugged driving before the effect of the drug subsides; conversely, THC can be 
detected for up to a month after use in frequent cannabis users. In addition, the relation between cannabis 
impairment and THC blood levels varies as a function of route of cannabis administration. 
Few controlled studies have assessed the pharmacokinetics and pharmacodynamics of vaporized or orally 
consumed intact cannabis (e.g., cannabis-containing brownies) on drug test results or behavioral 
evaluation of performance impairment. The pharmacokinetics and associated pharmacodynamics of 
cannabis administered via vaporization and oral consumption are currently not well understood and need 
to be better defined in order to evaluate methods of determining whether or not an individual under the 
influence of cannabis is impaired. The proposed study will involve acute administration of cannabis via oral 
ingestion and vaporization. We will evaluate pharmacokinetic outcomes across three biological matrices 
(blood, urine, oral fluid), in addition to subjective, observer-rated, and objective evaluations of drug effects 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 3 of 18 
 
and behavioral impairment. This study will directly impact policy related to cannabis impairment and DUID 
due to cannabis use. This will also help differentiate new from residual cannabis use, which would be a 
valuable asset in the clinical treatment of cannabis use disorders.  Currently, the most effective treatment 
for cannabis use disorder includes provision of incentives contingent on biologically confirmed abstinence.  
The problem is that frequent cannabis users often cannot pass a drug test until they have continuously 
abstained for several weeks.  Thus, many folks are not rewarded for initial abstinence success and may 
relapse prior to having a negative drug test.  Improving this methodology may result in increased drug 
treatment outcomes. 
 
In this study, we will establish behavioral and subjective effect profiles in parallel with pharmacokinetics in 
order to determine biological concentrations associated with impairment, and will conduct exploratory 
biomarker evaluation to identify biomarkers that can differentiate new from residual cannabis use. Study 
results will be used to establish scientifically based cut-off thresholds for impairment and DUID due to 
cannabis use and new test methods for use in drug treatment clinics. 
 
2. 
Objectives (include all primary and secondary objectives) 
 
Primary Objective 
 
P1: Determine candidate markers of cannabis use that track with level of impairment, as determined by 
subjective drug effect reporting, objective performance testing, and subjective DRE assessment. 
 
Secondary Objectives 
 
S1: Analyze effects of cannabis dosing across three biological matrices (blood, urine, oral fluid) within 
individuals based on route of administration (oral ingestion or inhalation). 
 
S2: Determine ability of oral mucosal biology to convert THC to THC-COOH (and potential impact on oral 
fluid testing). 
 
S3: Evaluate the sensitivity of existing and novel DRE assessments for detecting impairment following oral 
and inhaled cannabis dosing. 
 
S4: Identify potential association between cannabis analytes in biological matrices and performance and 
DRE assessments. 
 
  
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
Over the past decade, there has been a paradigm shift in legal status and social perception of cannabis in 
the United States. Twenty-nine states and the District of Columbia have legalized medicinal use of 
cannabis, and eight states have legalized adult non-medical (i.e. “recreational”) use (ProCon, 2016). 
Concurrent with this, rates of use and the potency of available cannabis have increased, and perceived 
harm related to use has decreased. Past-month use by persons 12 years or older increased from 11.5% in 
2011 to 12.1% in 2012 (United Nations Office on Drugs and Crime [UNODC], 2014), and in 2013, there 
were a reported 19.8 million users, up from 14.5 million in 2007 (Substance Abuse and Mental Health 
Services Administration [SAMHSA], 2014). Not surprisingly, there has been a corresponding increase in 
prevalence of detecting delta-9- tetrahydrocannabinol (THC, the primary psychoactive constituent in 
cannabis) in urine obtained from weekend nighttime drivers (up from 8.6% in 2007 to 12.6% in 2013-2014) 
(Berning, 2015).  
 
Current laws regarding cannabis impairment are either difficult to prosecute or are controversial. Effect-
based laws are the most common and least controversial, but are the most difficult to prosecute. They 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 4 of 18 
 
take into account the totality of circumstances and often rely on testimony or evidence from the arresting 
officer or a drug recognition expert (DRE), as well as results from a blood or urine toxicology test, with no 
clear definition of what constitutes a positive determination of impairment. Per se laws are easier to 
prosecute because they explicitly define an analyte and a cut-off concentration for that analyte; if a person 
has levels of that analyte above the cut-off concentration, that person is considered intoxicated and no 
further evidence of impairment need be demonstrated. Per se laws for cannabis impairment are 
controversial because there is a lack of consistency about both which analyte the laws are based on (e.g., 
THC or one of its metabolites), and the appropriate cut-off concentration to determine impairment. Some 
states have enacted zero tolerance per se laws, but in states that have legalized cannabis use, zero 
tolerance laws for cannabis are not practical because common biomarkers of cannabis use can be 
detected days after a single use and do not correspond with periods of impairment. In fact, there is little 
scientific evidence from which to determine appropriate objective measures for identifying cases of 
cannabis impairment and Driving Under the Influence of Drugs (DUID) due to cannabis impaired driving.  
 
Many controlled laboratory studies have been conducted to evaluate the acute effects of cannabis on 
various aspects of performance. This research indicates that cannabis reliably impairs attention (both 
focused and divided attention; see Vandrey & Mintzer, 2009 for review). There is some evidence that 
cannabis impairs motor ability and memory (short-term/working, episodic), but these effects do not appear 
to be very robust and are not observed consistently across studies (Chait, 1992). The acute effects of 
moderate doses of cannabis on motor ability and attention appear comparable to moderate doses of 
alcohol (BAC approximately 0.05%; Liguori et al., 1998; Ramaekers et al., 2004). In another study, 
impairment of episodic memory by multiple doses of alcohol and cannabis was shown to be dose-
dependent and of comparable severity at parallel points in the dose-response curve (Heishman et al., 
1997). With regard to the effects of cannabis on driving, research suggests that cannabis impairs driving 
ability and increases the risk of getting into an accident (for reviews, see Ramaekers et al., 2004; Asbridge 
et al., 2012).  
 
Currently, most local law enforcement use a combination of biological and behavioral assessments 
administered by DREs and blood THC levels, with cutoffs ranging from 1 to 5 ng/mL, to judge cases of 
suspected DUID involving cannabis. (Governors Highway Safety Association [GHSA], 2016) However, the 
behavioral assessments have not been explicitly developed to be sensitive for detecting acute intoxication 
from cannabis (Bosker, 2012; Fierro, 2014; Papafotiou, 2004; Bramness, 2010), and there are significant 
limitations to the use of blood THC levels as a proxy for impairment. First, THC is present at easily 
detected levels in the blood of individuals who have recently smoked cannabis but can drop below cutoffs 
used for drugged driving before subjective drug effects, and likely performance impairing effects, subside. 
Second, THC can be detected for up to a month after last use in a subset of frequent cannabis users 
(Bergmaschi, 2013). Also, though smoking remains the most common route of cannabis administration, 
cannabis is increasingly available in a wide array of “edibles” intended for oral ingestion (Vandrey, 2015).  
 
An estimated 16% to 26% of patients using medical marijuana consume edible products (Grella, 
2014; Walsh, 2013), and these types of products accounted for an estimated 40% of sales in Colorado 
dispensaries in 2014. Cannabinoids are highly lipophilic and subject to presystemic metabolism; thus, 
orally ingested THC has low bioavailability (6 to 20%) and delayed onset compared to inhaled THC from 
cannabis smoke (Huestis, 2007). Subjects who have consumed cannabis (or formulations containing 
active constituents) via oral ingestion can display signs of impairment with THC levels in their blood that 
are below limits of detection, or below a proposed cutoff value of 5 ng/mL (Ahmed, 2014; Vandrey et al., in 
press). Similarly, there has been a substantial increase in the use of vaporizers to inhale cannabis 
products. (Malouff, 2014; Budney/Lee, 2015) Similar to electronic cigarettes, cannabis and related 
products (e.g., oils, concentrated cannabis resins) can be inhaled using an assortment of hand-held or 
table-top electronic devices that vaporize cannabis and/or THC for pulmonary self-administration.  
 
Few controlled studies have assessed the pharmacokinetic and pharmacodynamics of vaporized or orally 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 5 of 18 
 
consumed intact cannabis (e.g., cannabis-containing brownies) on drug test results or behavioral 
evaluation of performance impairment. The pharmacokinetics and associated pharmacodynamics of 
cannabis administered via vaporization and oral consumption are currently not well understood and need 
to be better defined in order to evaluate methods of determining whether or not an individual under the 
influence of cannabis is impaired.  
 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
Protocol Overview.  The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology 
Research Unit (BPRU).  Participants will complete six outpatient drug administration sessions, each 
lasting approximately 10 hours and separated by at least 1 week. Participants will receive placebo and two 
active doses of cannabis via two different routes of administration: orally ingested (0mg, 10mg, 25mg) and 
inhaled vapor (0mg, 5mg, 20mg). Doses were selected based on prior research at the BPRU; the low 
active doses are expected to produce discriminative drug effects, but not impair performance, and the high 
doses are expected to produce both discriminative drug effects and performance impairment.  Each dose 
will be administered to each participant using a within-subjects crossover design. Dosing will be clustered 
by route of administration (e.g., first three sessions will involve oral administration followed by three 
sessions of vaporization), and route of administration will not be blinded due to difficulties in estimating the 
exact time of drug effect onset following oral administration. The order of route of administration will be 
counterbalanced across participants, and the order of doses within each three-session cluster will be 
randomized. Research volunteers will be recruited until 20 participants have completed the study.  
 
Participants.  We will recruit and consent up to 50 research volunteers in order to obtain 20 study 
completers.  We anticipate that some participants may drop out of the study before completion.  Based on 
recent studies using similar methodology, it is estimated that we will need to enroll 30 participants to 
achieve 20 study completers. 
  
The target demographic for study participation are healthy adults who: 1) have a history of intentionally 
consuming cannabis, 2) have not used cannabis in the past month (desire is to have participants free of 
cannabinoids in biological matrices at the time of initial drug administration), and 3) who are not currently 
dependent on or seeking treatment for use of cannabis or other psychoactive drugs. 
 
Participant recruitment. Participants will be recruited into the study via media advertising (e.g. newspaper, 
internet) and word-of-mouth communication.  Advertisements will seek healthy adults who occasionally 
use cannabis and are not currently trying to quit.  Interested participants will receive a brief screening over 
the telephone and will be scheduled for an in-person assessment if they meet initial eligibility criteria.   
 
Prior to the in-person assessment, written informed consent to administer the assessment will be 
obtained.  The assessment will be comprised of interviews and self-report surveys that provide participant 
information regarding health status including physical, mental health, and recreational drug use history 
(e.g. Medical History Interview, Drug-History Questionnaire, and Time-line Follow-Back [TLFB]).  Urine 
specimens will be obtained and tested for evidence of recent use of commonly abused drugs.  Participants 
must test negative for metabolites of THC, the primary psychoactive constituent of cannabis, and self-
report no cannabis use during the prior month.  Participants must provide a government-issued photo ID 
confirming they are 18-45 years old, report prior use of cannabis at least once in their lifetime, and report 
no allergies to any of the ingredients used to prepare the brownies (e.g., chocolate, egg, wheat, etc.) used 
as a vehicle for oral cannabis administration. Study participants will also undergo a physical exam 
including clinical chemistry, hematology, serology, and serum pregnancy test (females only).  An 
electrocardiogram (EKG) reading will be obtained and reviewed by a physician or nurse practitioner to 
assess current cardiovascular health. Additionally, participants will be required to demonstrate that they 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 6 of 18 
 
can expectorate at least 3 mL of “native” oral fluid (saliva) over a 5-minute period.  Those who appear 
eligible for participation will receive training on the study assessment measures (e.g. exposure to 
subjective questionnaires, DRE assessments, and cognitive performance tasks).   
 
Experimental Session Procedures. For all study sessions, participants will be scheduled to arrive early in 
the morning on the day of cannabis exposure.  All participants will complete a breath alcohol test on 
arrival.  Participants with a positive BAL will be immediately discharged from the study.  Urine drug and 
pregnancy testing will then be conducted for all participants to test for evidence of recent illicit drug use 
(e.g. cannabis, cocaine, opioids) and pregnancy.  Volunteers must have negative urine drug screens on 
the day of the cannabis exposure session to participate.  Based upon results from previous studies in our 
laboratory, the one-week minimum interval between sessions should be sufficient for eliminating 
cannabinoids between test days in such a manner that positive urine drug screens from the prior study 
exposure is not a concern.  Participants will be fed a standardized low fat breakfast (e.g. toast and jam) 
each morning prior to cannabis administration and will be provided lunch and snacks at predetermined 
times post drug administration.  
 
Baseline Assessments.  Prior to cannabis administration, participants will have an indwelling intravenous 
catheter inserted for blood collections. Baseline oral fluid, urine, and blood and will be obtained from all 
participants. Baseline cardiovascular, subjective, DRE, and performance assessments will also be 
conducted (see below for details), and the TLFB will be conducted to record substance use since the last 
study visit (intake assessment or prior to experimental session).  Concomitant medications, including 
vitamins and herbal supplements taken within 14 days prior to experimental session will be recorded.  
Changes in medication occurring between the screening assessment and experimental session will be 
reviewed by a study investigator and medical staff prior to cannabis administration to ensure the volunteer 
is still eligible to participate. 
 
Cannabis Exposure. After baseline assessments are completed, participants will receive either an oral or 
an inhaled cannabis exposure. Cannabis will be obtained from the NIDA Drug Supply Program and 
prepared accordingly for the two routes of administration (see below). For ease of dose calculation, we will 
obtain cannabis containing approximately 10% THC by volume for active dose administration and placebo 
cannabis for the “0mg” dose conditions. Because most cannabis available for medical and non-medical 
use is high in THC and low in minor cannabinoid content, the cannabis used in this study will not contain 
more than a 3% concentration of cannabinoids other than THC (e.g. CBD, CBG, CBC). Cannabis dose 
assignment will be blinded in this study; however, route of administration will not be blinded due to 
difficulties in timing drug onset and peak effects across oral and inhaled cannabis for a double-dummy 
drug administration procedure. 
 
Oral Administration. Participants will self-administer a brownie containing cannabis measured to produce 
THC exposure of 0, 10mg, or 25mg. Participants will receive each cannabis dose (one per session) in a 
randomized order on three consecutive sessions. Cannabis brownies will be prepared using individual 
baking trays for each dose. Baking will occur using a small oven located in the BPRU pharmacy and a 
commercial brownie mix. The mix will be prepared according to manufacturer’s instructions, with a 
measured dose of finely ground cannabis added to a portion the brownie batter mixture sufficient to make 
one cannabis brownie. The plant material will be pre-heated to decarboxylate THCA to free THC. We have 
prepared brownies individually in this manner for previous studies and verified that this preparation 
method ensures that target THC cannabis doses can be reliably achieved. Study participants and 
research staff will be blind to dose assignment. Participants will be provided with cannabis brownies and 
drinking water approximately 1 hour after finishing their standardized low-fat breakfast, and will be 
instructed that they need to consume the brownie within 5 minutes. The conclusion of cannabis brownie 
consumption will be considered the “0 hour” by which remaining protocol assessments will be scheduled. 
 
Vaporization. Participants will inhale vapor produced from cannabis plant material measured to contain 0, 
5mg, or 20mg THC. Vaporization will be achieved using The Volcano desktop vaporizing device (Storz & 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 7 of 18 
 
Bickel, Oakland, CA). The appropriate amount of cannabis plant material will be vaporized and trapped in 
an opaque balloon. Participants will be instructed to inhale the air from the balloon ad-libitum until the 
balloon is empty. This will be repeated for the inhalation of 3 balloons and within a 10-minute time period 
to ensure the dose is completely delivered and to minimize variability in the time course and magnitude of 
drug effects. To minimize bias, the placebo dose will be prepared using vaporized “placebo” cannabis 
(THC and other cannabinoids extracted), so that a visible vapor will still be exhaled after each breath. 
Participants will receive each cannabis dose (one per session) in a randomized order. Study participants 
and research staff will be blind to dose assignment. Vaporized cannabis administration will begin 
approximately 1 hour after finishing their standardized low- fat breakfast. The conclusion of cannabis 
inhalation period will be considered the “0 hour” by which remaining protocol assessments will be 
scheduled. 
 
Outpatient Discharge. Participants will be discharged after completing final assessments (approximately 
8.5 hours post-exposure).  In 3 prior studies conducted in our laboratory, this timeline has been adequate 
for healthy adults to resolve any effects from acute doses of cannabis that are equal to or greater than 
those use in the present protocol. If a study participant indicates the desire to be discharged from the 
study early, BPRU medical staff will review the self-reported rating of “drug effect” on the most recent 
subjective drug effect assessment and conduct a brief interview with the participant prior to discharge.  At 
the end of each session, Study staff will compare vital signs and cognitive performance assessments with 
baseline data and engage in face-to-face conversation with the participant to ensure that they are fit to 
leave the unit.  Cognitive performance tasks obtained include measures of psychomotor ability, working 
memory and divided attention.  If the participant is able to cognitively engage with staff, vital signs are 
within normative range (HR < 100bpm, SYS BP < 160mmHg, DIA BP < 90mmHg), and performance is not 
below 10% of baseline, the participant will be cleared to leave without further evaluation.  If any of these 
parameters are not met, medical staff will assess the participant and a formal field sobriety test will be 
conducted.  If the participant reports a drug effect or exhibits behavior indicative of impairment/intoxication, 
the participant will be asked to remain at the BPRU until the drug effect subsides and they can pass a field 
sobriety test.  If vital signs are out of range, then medical staff will evaluate and make a determination with 
regards to whether it is safe for participant to be discharged or remain under observation.  Participants will 
not be allowed to drive home; instructions will be provided at the screening session regarding the need to 
make alternative transportation arrangements.  If a participant fails to arrange a ride, taxi transportation 
home will be coordinated by study staff and provided free of charge.  
 
Study Measures. A battery of measures will be used to assess participant characteristics and drug effects 
during the study. 
 
Screening. During the laboratory screening assessment, a battery of measures will be administered to 
collect background demographic data (age, gender, self-reported race and ethnicity, height, and weight) 
and to determine study eligibility (e.g. Medical History Interview, Drug-History Questionnaire, and Time-
line Follow-Back (TLFB)).  A physical examination will be performed on each subject during the Screening 
Visit.  All major organ systems, including head, eyes, ears, nose, and throat (HEENT); cardiovascular 
system; lungs; abdomen (liver/spleen); extremities; skin; central nervous system (CNS); musculoskeletal 
system, and general appearance.  A 12-lead EKG will be conducted to ascertain cardiovascular health 
and biological specimens will be tested for routine clinical chemistry, hematology, serology, serum 
pregnancy test (females only), and for evidence of recent illicit drug use. 
 
Experimental Sessions.  Vital signs (heart rate, systolic blood pressure (SBP), diastolic blood pressure 
(DBP)) will be measured in the seated position at baseline, immediately after administration, and 1, 2, 3, 4, 
5, 6, and 8 hours post exposure.  
 
Blood sampling (6 mL per specimen) will occur 8 times during each experimental session.  For 
vaporization sessions, blood will be collected at baseline, immediately after administration, and 1, 2, 3, 4, 
6, and 8 hours post exposure. For oral administration sessions, blood will be collected at baseline, 1, 2, 3, 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 8 of 18 
 
4, 5, 6, and 8 hours post exposure.  Participants will have an indwelling intravenous catheter inserted prior 
to the start of the exposure session.  Six milliliters of blood will be collected by catheter at designated 
times into vacutainer tubes (gray top). Blood will be centrifuged and plasma will be divided into three 
plastic cryotubes, labeled and stored frozen at -80 ºC until shipped frozen on dry ice to a designated 
laboratory for analysis. 48mL of blood will be obtained per session for a total of 288mL of blood across the 
6 outpatient sessions.  
 
Oral fluid sampling will occur at the same time points as blood sampling (see above). Collection of oral 
fluid specimens will be performed using a Quantisal collection kit (Immunalysis Inc., Pamona, CA).  No 
food or drink will be allowed during collection and for a period of 10 minutes prior to each scheduled 
collection.  Each specimen will be sealed with a plastic screw cap and stored refrigerated until shipped to 
a designated laboratory. 
 
Spot urine specimens will be collected into empty, clean, plastic collection containers, labeled with the 
participant’s identification number, date, and collection time at baseline, 1, 2, 3, 4, 5, 6, and 8 hours post 
exposure. Urine will be stored frozen at -20 ºC. A total of 60 urine samples will be collected across the 6 
outpatient sessions.  
 
An FDA-approved cardiac monitor will be attached to study participants via disposable electrodes. 
Participants will be instructed on how and where to place the sensor on their chest and research staff will 
ensure it is properly placed. The sensor will be applied at baseline and will be worn continuously 
throughout each session. The device will log 1 lead electrocardiogram and 3-axis accelerometer data to 
memory. After the device is removed from the participant the data will be uploaded to a computer for 
analysis.   
 
A 21-item Drug Effect Questionnaire will be used to obtain subjective ratings of intoxication.  Individual 
items include ratings of drug effects (i.e. drug effect, good effect, bad effect) and behavioral/mood states 
often associated with marijuana intoxication (i.e. relaxed, paranoid, hungry/have munchies).  Participants 
will rate each item using a 100mm visual analog scale (VAS) anchored with “not at all” on one end and 
“extremely” on the other.  This questionnaire will be administered at baseline, immediately after 
administration and 1, 2, 3, 4, 5, 6, and 8 hours post exposure.  It is expected that all subjective drug 
effects will subside by Hour 8, but if a participant reports a drug effect beyond this time the questionnaire 
will continue to be administered at other time points until the participant no longer reports a drug effect. 
 
Performance assessments will be conducted on aspects of cognitive/psychomotor functioning known to be 
sensitive to the acute effects of smoked marijuana and relevant to functioning in the workplace and/or in 
operating a motor vehicle or heavy machinery. All participants will be trained on the performance tasks to 
a stable baseline level during the screening session.  Tasks include: 1) Divided Attention Task (DAT): 
Participants simultaneously perform two different simple tasks based on visual stimuli presented on a 
computer screen.  Primary outcome is the accuracy with which they perform the two tasks; 2) Digit Symbol 
Substitution Task (DSST):  Participants must hand type patterns presented to them on a computer screen 
for 90 seconds.  Primary outcomes are accuracy and total number of patterns completed in the allotted 
time; and 3) a computerized version of the Paced Auditory Serial Addition Task (PASAT):  Participants are 
provided a string of single digit numbers on the computer and must add the total of the prior to integers 
presented and respond by selecting the answer using the computer mouse on the screen. The primary 
outcome is a summed score of the number of correct trials during the task.  We will also administer a brief 
(2-minute) cognitive test battery on an iPad.  The DRUID App is currently under development as a 
potential screening tool for identification of impairment in individuals in workplace or roadside settings. The 
app utilizes tasks that measure similar performance domains as those used in the task battery described 
above (divided attention, psychomotor ability, working memory), but is much more abbreviated. This will 
help us determine the relative sensitivity of the app in detecting impairment relative to the more lengthy 
assessment battery we have traditionally used in our studies.  Performance assessments will be 
completed at baseline, immediately after drug exposure, and 1, 2, 3, 4, 5, 6, and 8 hours post exposure.   


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 9 of 18 
 
 
A battery of DRE assessments will include currently practiced assessments that have been found to be 
most sensitive to effects of cannabis impairment (e.g., walk-and-turn, one-leg stand, lack of convergence, 
and horizontal gaze nystagmus). Eye movements will be recorded using an eye-tracking camera during 
the assessment, which will include measures of eye convergence, horizontal gaze nystagmus, and pupil 
size. Note: this eye-tracking camera will gauge which tracking paths produce characteristic involuntary eye 
movements that a trained officer could observe without the aid of a recording device. We are not 
proposing that the camera itself would be used in a roadside testing environment. All DRE assessments 
will be recorded using a web camera which will be set up by the research staff member running the 
session. The purpose of these recordings is to assure valid ratings on the DRE assessments and to allow 
for re-coding performance of study completers if new “clues” about impairment are established during the 
course of the study. Consent for videotaping will be obtained from all study volunteers and video 
recordings will not be shared outside the study team without additional written consent of the individual 
study participant. These assessments will be completed at baseline, immediately after exposure, and 1, 2, 
3, 4, 5, 6, and 8-hours post exposure.  
 
The eye-tracking camera (e.g. DAX Evidence Recorder) automatically quantifies and assesses the 
involuntary eye movements (e.g. gaze nystagmus) that occur when a user is asked to visually follow an 
object (e.g. a pencil moved back and forth). We will evaluate whether cannabis administration impacts 
gaze nystagmus, eye convergence, and changes in pupil size when ambient room lighting is 
brightened/darkened. The eye convergence test involves asking the participant to follow the test 
administrator’s finger (or a pencil) with their eyes as it moves from far to close to the nose (without 
touching the participant). 
  
b. Study duration and number of study visits required of research participants. 
 
All participants will complete a visit for screening evaluation. Participants meeting eligibility criteria will be 
enrolled in the study and complete 6 outpatient drug administration sessions, lasting approximately 10 
hours each, and spaced at least one week apart.   
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Cannabis dose assignment will be blinded in this study, but route of administration will not.  It is standard 
procedure for appropriate scientific control in studies evaluating dose effects of psychoactive drugs to 
blind dose assignment.  Blinding of route of administration is not necessary and would be difficult to 
manage in this study given the immediacy of effects via inhaled routes and the unpredictable delay in drug 
onset effects following oral administration. 
 
d. Justification of why participants will not receive routine care or will have current therapy 
stopped.  
 
Participants in this study will be healthy volunteers.  Routine care for any medical illness that may arise 
during participation will not be affected. 
 
e. Justification for inclusion of a placebo or non-treatment group. 
 
A placebo dosing session will be included to help interpret active drug effects on pharmacodynamic 
outcomes. Placebo dosing provides a control for expectancy effects on subjective reports and cognitive 
performance as well as non-pharmacological factors such as fatigue, hunger, and learning effects on 
performance tasks. Placebo dosing is standard for research studies involving evaluation of acute drug 
effects. 
 
f. 
Definition of treatment failure or participant removal criteria. 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 10 of 18 
 
 
This is not a treatment study.  Participants may quit participation at any time of their own volition.  The 
study investigators will discharge study participants for failing to attend their scheduled session, failure to 
follow the protocol requirements, or for other reasons not known at this time. 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
This is not a treatment trial; there is no direct course of therapy related to the participant population being 
targeted.  We are recruiting healthy adults with experience using cannabis and who are not seeking 
treatment for substance use problems.  Should any report the desire for treatment they will be referred to 
appropriate community service centers.  Premature termination of participation may result in the need to 
recruit additional research volunteers, but should have no impact on the study volunteer directly.  
 
5. 
Inclusion/Exclusion Criteria 
 
Participants will meet the following eligibility criteria: 
Inclusion Criteria 
1. 
Have provided written informed consent 
2. 
Be between the ages of 18 and 45  
3. 
Be in good general health based on a physical examination, medical history, vital signs, 12-
lead ECG and screening urine and blood tests  
4. 
Test negative for recent cannabis use in urine at the screening visit (confirmed by GC/MS 
laboratory test) and at clinic admission 
5. 
Test negative for other drugs of abuse, including alcohol at the screening visit and at clinic 
admission 
6. 
Demonstrate ability to expectorate 3-5 mL of “native” oral fluid over a 5-minute period 
7. 
Not be pregnant or nursing (if female).  All females must have a negative serum pregnancy 
test at the screening visit and a negative urine pregnancy test at clinic admission. 
8. 
Have a body mass index (BMI) in the range of 19 to 36 kg/m2 
9. 
Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 
mmHg or a diastolic blood pressure (DBP) of 90 mmHg 
10. 
Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, 
eggs, wheat, etc.).   
11. 
Report prior experience inhaling cannabis (either via smoking or vaporization).  
12. 
Have not donated blood in the prior 30 days. 
 
Exclusion Criteria 
1. 
Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine 3 months  
prior to the Screening Visit; 
2. 
History of or current evidence of significant medical or psychiatric illness judged by the 
investigator to put the participant at greater risk of experiencing an adverse event due to 
exposure or completion of other study procedures.  
3. 
Use of an OTC, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 
days of experimental sessions; which, in the opinion of the investigator or sponsor, will 
interfere with the study result or the safety of the subject. 
4. 
Use of a prescription medication (with the exception of birth control prescriptions) within 14 
days of experimental sessions; which, in the opinion of the investigator or sponsor, will 
interfere with the study result or the safety of the subject. 
5. 
Use of hemp seeds or hemp oil in any form in the past 3 months. 
6. 
Use of dronabinol (Marinol) within the past 6 months. 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 11 of 18 
 
7.  
History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, 
or other significant oral cavity disease or disorder that in the investigator’s opinion may 
affect the collection of oral fluid samples. 
8. 
History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., 
Prinzmetal’s angina). 
9. 
Abnormal EKG result that in the investigator’s opinion is clinically significant. 
10. 
Epilepsy or a history of seizures. 
11. 
Enrolled in another clinical trial or have received any drug as part of a research study within 
30 days prior to dosing. 
12. 
Individuals who have a recent history of traumatic brain injury diagnosed 
by CT/MRI and have current sequela from prior brain injury, as determined by the 
study physician 
 
13.  
Individuals with anemia 
 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 
All cannabis will be obtained specifically for use in this study from the Federal Drug Supply System. For 
oral administration, brownies will be made by the BPRU pharmacy and will contain target THC doses of 0, 
10mg, or 25mg, (e.g., 100 or 250mg of cannabis material that is approximately 10% THC by volume; or 
250mg cannabis for which THC and other cannabinoids has been extracted).  For vaporization, THC 
doses of 0, 5mg, and 20mg will be administered. Cannabis will be vaporized using a commercial vaporizer 
called The Volcano (Storz and Bickel, GmbH & Company (Oakland, CA).  To preserve the blind, we will 
mix active and placebo cannabis so that the same amount of plant material is placed in the vaporizer at 
each session.  For example, if we obtain cannabis with 10% THC, the placebo dose will contain 200mg 
cannabis for which THC and other cannabinoids has been extracted.  The 5mg THC dose will contain 50 
mg cannabis with 10% THC and 150mg cannabis for which THC and other cannabinoids has been 
extracted.  The 20mg dose will contain 200mg cannabis with 10% THC.  Selection of doses was 
conducted to balance participant safety and tolerability based on our previous experience, and to 
administer 2 active doses the are expected to produce subjective drug effects via each route of 
administration, but only one that produces significant impairment of performance ability.  This will help test 
the sensitivity of the biological and behavioral assessments for detecting impairment versus discriminable 
drug effects. We have experience safely delivering acute cannabis doses within the range utilized in this 
study with healthy adult volunteers who are not frequent cannabis users.  
 
Potential risks of consuming cannbis in the present study are stomach/gastrointestinal irritation and 
adverse effects associated with cannabis intoxication.  We have considerable experience administering 
smoked, vaporized, and oral cannabis in our laboratory.  Recently, using essentially the same protocol, we 
have administered up to 50mg THC via oral cannabis ingestion and up to 25mg THC via cannabis 
vaporization.  Following 25mg oral THC administration to 23 healthy adults, one participant vomited and 
one participant experienced a brief period of anxiety.  The participant who vomited experienced immediate 
relief of discomfort and the case of anxiety was resolved within about one hour of onset without the need 
for medical intervention.  In both the oral cannabis study as well as a recently completed study of 
vaporized cannabis exposure, transient experiences of dizziness and nausea were reported by a minority 
of participants, the effects were dose-dependent, but did not result in the need for intervention and no 
participants withdrew participation as a result.  In fact, half of the participants who completed the oral 
cannabis study volunteered for and completed the protocol extention involving smoked and vaporized 
cannabis administration one year later (those who elected not to return did so because of work conflicts or 
because they moved).  By reducing the maximum doses administered in this study, we believe that we will 
still achieve our target behavioral outcomes, and maintain safety and tolerability of doses for study 
volunteers. That said, we still have adequate procedures in place to handle adverse events.  The research 
space has multiple restrooms and bio-hazard waste containers for use in cases of vomiting.  In cases 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 12 of 18 
 
where a participant experiences panic and or paranoid reactions, research staff will engage the person in 
relaxation exercises and will suspend research procedures until the volunteer has regained comfort.  
These types of effects are typically of short duration.  Acute cannabis exposure is expected to result in a 
time-limited increase in heart rate and orthostatic hypotension.  If heart rate increases above 120bpm, 
blood pressure increases above 160/90mmHg or drops below 90/50mmHg, a nurse practitioner or 
physician will be notified and will evaluate the study participant.  The NP/MD will determine whether there 
is a need for urgent care versus continued observation and evaluation.  In the case of an extreme adverse 
reaction, study staff will call 911 and EMTs will take participants across the street to the Johns Hopkins 
Bayview ER for treatment.  
 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. 
 
Not applicable to this protocol. 
 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
Not applicable to this protocol.  An IND has been obtained for the administration of cannabis. 
 
Study Statistics 
 
a. Primary outcome variable. 
 
The primary outcome variables are the quantitative levels of THC and its metabolites in biological matrices 
(oral, urine, blood), subjective rating of “Drug Effect” on the DEQ, and performance on DRE and 
cognitive/psychomotor assessments. 
 
b. Secondary outcome variables. 
 
Secondary outcome variables include subjective drug effect and mood ratings on additional items of the 
DEQ and vital signs. 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
 
The sample size estimate for this study was based on previous work in our laboratory evaluating dose 
effects of acute drug administration using a within-subjects design.  A meta-analysis was previously 
conducted comparing the statistical power of 13 drug effect assessments from six dose-effect studies, with 
14 participants each, evaluating a range of abused drugs in our laboratory (Felch, 1996). The analysis 
showed that average effect size for primary measures (i.e. subjective drug effect ratings, staff ratings and 
behavioral/cognitive performance measures) ranged from approximately 0.87 to 1.0. Based on this 
estimate of effect size, the proposed sample size of 20 should be adequate to assess the expected 
effects. This sample selection methodology has been consistent in our long history of studies investigating 
dose-effects comparisons of different drugs, which have demonstrated excellent external validity and have 
become the FDA recommended standard for human abuse liability assessment.  Subjective drug effect 
and mood ratings, vital signs, DRE assessments and cognitive performance outcomes will be assessed 
using multiple regression analyses appropriate for repeated measures testing based on the final 
characteristics of the data set (e.g. normal distribution, skewness, kurtosis). 
 
d. Early stopping rules. 
 
The study will be stopped if new information is learned that indicates a serious risk to study participants. 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 13 of 18 
 
 
7. 
Risks 
 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
 
Potential risks of cannabis exposure include dizziness, change in blood pressure, red or irritated eyes, 
drowsiness, easy laughing, euphoria, rapid heart rate, dry mouth, jitters, headache, nausea, vomiting, 
increased appetite, perceptual difficulties, memory lapse, hallucinations, confusion, depression, paranoid 
reaction, depersonalization, and rash. Additional potential risks of orally consuming cannabis are 
stomach/gastrointestinal irritation.  We feel that the risk of serious adverse events related to cannabis 
exposure in this study is minimal, participants are experienced users and the doses we are administering 
are within the range by which most participants in our prior studies have had good tolerance to the drug.  
 
Venous blood sampling may cause pain, tenderness, bruising, or bleeding at the needle puncture site.  
Some subjects may feel transient lightheadedness or dizziness, or lose consciousness (syncope), 
because of anxiety and vasovagal reaction. The only risk associated with oral fluid collection is dryness of 
the mouth. 
 
A further risk is that participants may mistake the proposed studies as treatment or may delay treatment 
seeking in order to participate, although this is unlikely since we are targeting occasional users.   
 
The cardiac sensor should not be worn by subjects with a pacemaker or defibrillators.  
 
The eye-tracking camera will include exposure to flashing lights and light patterns. Some people with 
photosensitive epilepsy are susceptible to epileptic seizure or loss of consciousness when exposed to 
certain flashing lights or light patterns in everyday life. While the illumination of the eye tracking camera is 
continuous and invisible to the subjects, we will exclude from testing subjects with epilepsy or a history of 
seizure. The safety of the near-infrared lighting source was assessed using the guidelines set forth in the 
IEC 62471/CIES009-2006, Photobiological Safety of Lamps and Lamp Systems Optical Standard. The 
power output of the lighting source was measured with a commercial calibrated powermeter 
(Thorlabs  PM100D) and used to determine irradiance and radiance. The standard specifies an irradiance 
safety limit of 100 W/m2, this is the maximum recommended irradiance for day-long continuous exposure 
by ACGIH, American Conference of Governmental Industrial Hygienists; the RTI custom system 
measured 44.1 W/m2. The standard also specifies a maximum radiance limit of 60 mW/mm2/sr, and our 
system measured a radiance of 0.36 mw/mm2/sr.  
 
Breach of confidentiality about self-reported drug use, biological tests indicating recent drug use, and 
study participation is a risk.   
 
b. Steps taken to minimize the risks. 
 
Participants are not a "vulnerable population" as defined by human subjects protection guidelines; that is, 
they are not minors, pregnant women, under legal coercion or restriction, or mentally impaired.  They are 
competent adults who provide their voluntary informed consent.  Participants will be recruited via media 
advertisements and posters that clearly state the nature and intent of the study.  The consent process will 
inform the participant in detail of the procedures, time involvement, compensation, risk, and treatment 
options other than participation in our study.  Particular emphasis will be given to providing information 
regarding the potential risks involved with taking the study drugs.  Volunteers will also be instructed that 
they may withdraw from participation at any time without losing any of the compensation that they have 
earned to that point.   
 
It is unlikely that any adverse event should arise that requires immediate medical or psychiatric treatment. 
However, in case of an adverse event, participants will be under the supervision of medical/nursing staff 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 14 of 18 
 
throughout the study.  The medical and nursing staff at BPRU are trained in CPR and mobile emergency 
crash carts are available on the same corridor where all experimental procedures will be conducted.  The 
research facility (BPRU) is located directly across the street from the Johns Hopkins Bayview Medical 
Center Emergency Department, and, in case of an adverse event, participants will be taken for immediate 
care.  The Principal Investigator will be immediately notified of any serious adverse events that arise. 
 
If participants develop nausea or vomiting after consuming cannabis, study staff will assist the affected 
participant(s) appropriately and contact a study physician located in the building should the PI and/or study 
staff decide the participant would benefit from medical attention.  
 
Blood collection risk will be minimized by performing venipuncture while participants are sitting down, and 
by having them remain under staff observation until it is clear that no acute adverse effects occur as a 
result of the procedure.  The risk of infection is negligible because standard sterile technique will be used.  
Placement of indwelling venous catheters poses a risk of infection or thrombophlebitis, which increases 
with duration of placement.  This risk is minimized by use of careful sterile techniques and catheter 
placement by experienced nursing staff. The risk of anemia is negligible because the total amount of blood 
to be collected during the study (5 mL at screening and 288mL during sessions) is less than the amount 
(473 mL) collected within one hour during a single blood donation session.  The amount of blood loss will 
be readily replaced without harm to study participants. 
 
Individuals with a pace maker or defibrillator will not be given a heart rate monitor to wear during sessions.  
It is unlikely that any study volunteer with such devices would meet study eligibility requirements. 
 
All advertisements and the informed consent process will clearly indicate that this research is designated 
only for those not seeking treatment, that participation is not a substitute for treatment, and that 
participation offers no clinical benefit.  They will be clearly informed that they will be asked to ingest 
cannabis brownies and vaporized cannabis during their participation.  Any participant who expresses an 
interest in receiving immediate treatment for cannabis or other substance use will be referred to a 
community treatment clinic.  If this occurs during the study, their participation in the study will be 
terminated.  As previously described, participants will be instructed that should they withdraw from the 
study at any point to pursue treatment they will still be compensated for their participation up until that 
point in the study. 
 
Confidentiality will be maintained by using study specific identifiers, rather than participant names, on all 
study-related documents as possible, following standard human subjects practice for protecting PHI, and 
keeping all documents and video with PHI in secure physical and digital environments. 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
The PI will also follow ICH regulations (detailed in Clinical Safety Data Management, Definitions, and 
Standards for Expedited Reporting) regarding reporting of adverse events and all study deviations to the 
IRB and study sponsor. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
Participants’ names will be recorded only on the screening, informed consent, and necessary medical and 
payment forms.  Anonymous participant identification numbers will be used on all other forms and labeling 
of biological fluids and test results.  Video footage of the field sobriety assessments will be stored 
internally on password protected computers and servers that conform to JHU IT standards and will not be 
shared outside the study team.  All information gathered will be kept in locked research staff offices or file 
cabinets.  All medical information obtained will be handled in accordance with HIPAA regulations. Only 
research staff will have access to participant records. The limits of confidentiality (e.g. suspected child 
abuse or neglect, or harm to self or others) will be discussed in detail with the participants during the 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 15 of 18 
 
informed consent process.  To reduce the likelihood of patient records disclosure we have obtained a 
Certificate of Confidentiality.  
 
e. Financial risks to the participants. 
 
This study does not involve patients receiving treatment; therefore, the financial risks are minimal. 
Participants will be fairly compensated for their time and effort in complying with the study protocol. 
 
8. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
The primary benefit of the proposed research is in the knowledge gained regarding the relative biological, 
subjective and behavioral dose effects of exposure to cannabis administered orally, or via vaporization.  
The knowledge will be used to advise the establishment of new drug testing guidelines across different 
biological matrices, and will inform the relevance of oral administration vs. inhalation on interpretation of 
workplace or roadside drug testing.  The study will also extend the extant literature investigating the acute 
dose effects of cannabis, including subjective effects, cognitive performance, and their correlation with 
biological cannabinoid levels. Because we anticipate relatively minor risks to these cannabis experienced 
study participants, we feel that the proposed research has a positive risk benefit ratio. 
 
9. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed 
bonus, and any proposed reductions or penalties for not completing the protocol. 
 
All participants will be compensated $30 for completing the screening assessment.  Compensation for full 
participation is $2030. Compensation of this magnitude is appropriate given the length and nature of this 
study. 
 
 
 
 
Screening Visit:    
 
$30  
 
 
 
Sessions:  
 
 
$300/session ($1800 total) 
 
 
 
Completion Bonus: 
 
$500        
     
 
 
 
Total Compensation:  
$2330  
 
10. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
The only direct costs to the participants will be their transportation to and from Bayview for each study 
visit.  That cost has been factored into the compensation for participating. 
 
 
 
 
 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 16 of 18 
 
 
Reference List 
 
Abrams, D.I., Vizoso, H.P., Shade, S.B., Jay, C., Kelly, M.E., & Benowitz, N.L. (2007). Vaporization as a 
smokeless cannabis delivery system: a pilot study. Clinical Pharmacology & Therapeutics, 82, (5), 
572-8.  
Ahmed, A.I.A., van den Elsen, G.A.H., Colbers, A., van der Marck, M.A., Burger, D.M., Feuth, T.B., 
Rikkert, & M., Kramers, C. (2014). Safety and pharmacokinetics of oral delta-9- 
tetrahydrocannabinol in healthy older subjects: A randomized controlled trial. Eur. 
Neuropsychopharmacology., 24, (9), 1475-1482.  
Asbridge, M., Hayden, J.A., & Cartwright, J.L. (2012). Acute cannabis consumption and motor vehicle 
collision risk: systematic review of observational studies and meta-analysis. BMJ, 344.  
Bergamaschi, M.M., Karschner, E.L., Goodwin, R.S., Scheidweiler, K.B., Hirvonen, J., Queiroz, R.H., & 
Huestis, M.A. (2013). Impact of prolonged cannabinoid excretion in chronic daily cannabis 
smokers' blood on per se drugged driving laws. Clinical Chemistry, 59, (3), 519-26.  
Berning, A., Compton, R., & Wochinger, K. (2015). Results of the 2013-2014 National Roadside Survey of 
alscohol and drug use by drivers. (Traffic Safety Facts Research Note. Report No. DOT HS 812 
118). National Highway Traffic Safety Administration: Washington, DC.  
Bosker, W.M., Theunissen, E.L., Conen, S., Kuypers, K.P., Jeffery, W.K., Walls, H.C., Kauert, G.F., 
Toennes, S.W., Moeller, M.R., & Ramaekers, J.G. (2012). A placebo-controlled study to assess 
Standardized Field Sobriety Tests performance during alcohol and cannabis intoxication in heavy 
cannabis users and accuracy of point of collection testing devices for detecting THC in oral fluid. 
Psychopharmacology (Berlin), 223, (4), 439-46.  
Bramness, J.G., Khiabani, H.Z., & Morland, J. (2010). Impairment due to cannabis and ethanol: clinical 
signs and additive effects. Addiction, 105, (6), 1080-7.  
Caulkins, J.P., Kilmer, B., MacCoun, R.J., Pacula, R.L., & Reuter, P. (2012). Design considerations for 
legalizing cannabis: lessons inspired by analysis of California's Proposition 19. Addiction, 107, (5), 
865-871  
Chait, L., & Pierri, J. (1992). Effects of smoked marijuana on human performance: A critical review. In 
Marijuana/cannabinoids: Neurobiology and neurophysiology, Murphy, L., Bartke, A., Eds. CRC 
Press: Boca Raton, FL, 387-423.  
Fant, R.V., Heishman, S.J., Bunker, E.B., & Pickworth, W.B. (1998). Acute and residual effects of 
marijuana in humans. Pharmacology Biochemistry and Behavior, 60, (4), 777-84.  
Felch, L., Di Marino, M., & Griffiths, R. (1995). A meta-analysis of psychomotor, subject- and observer- 
rated effects in abuse liability studies of anxiolytics. In Problems of Drug Dependence, Harris, L. S., 
Ed. Government Printing Office: Washington, DC, 1996.  
Fierro, I., Gonzalez-Luque, J.C., & Alvarez, F.J. (2014). The relationship between observed signs of 
impairment and THC concentration in oral fluid. Drug and Alcohol Dependence, 144, 231-8.  
GHSA Drug-Impaired Driving Laws. http://www.ghsa.org/html/stateinfo/laws/dre_perse_laws.html 
(accessed January 6, 2016).  
Grella, C.E., Rodriguez, L., & Kim, T. (2014). Patterns of Medical Marijuana Use Among Individuals 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 17 of 18 
 
Sampled from Medical Marijuana Dispensaries in Los Angeles. Journal of Psychoactive Drugs, 46, 
(4), 263-272.  
Heishman, S.J., Arasteh, K., & Stitzer, M.L. (1997). Comparative effects of alcohol and marijuana on 
mood, memory, and performance. Pharmacology Biochemistry and Behavior, 58, (1), 93-101.  
Huestis, M.A. (2007). Human Cannabinoid Pharmacokinetics. Chemistry & Biodiversity, 4, (8), 1770- 
1804.  
Huestis, M.A., & Smith, M.L. (2014). Cannabinoid pharmacokinetics and disposition in alternative 
matrices. In Handbook of Cannabis, Pertwee, R. G., Ed. Oxford University Press: Oxford, UK.  
Kilmer, B., Caulkins, J.P., Pacula, R.L., MacCoun, R.J., & Reuter, P. (2010). Altered state? Assessing how 
marijuana legalization in California could influence marijuana consumption and public budgets. 
RAND Drug Policy Research Center: Santa Monica, CA.  
Lee, D. C., Crosier, B. S., Borodovsky, J. T., Sargent, J. D., & Budney, A. J. (2016). Online survey 
characterizing vaporizer use among cannabis users. Drug and alcohol dependence, 159, 227-233.  
Liguori, A., Gatto, C.P., & Robinson, J.H. (1998). Effects of marijuana on equilibrium, psychomotor 
performance, and simulated driving. Behavioural Pharmacology, 9, (7), 599-609.  
Malouff, J.M., Rooke, S.E., & Copeland, J., (2014). Experiences of marijuana-vaporizer users. Substance 
Abuse, 35, (2), 127-8.  
Papafotiou, K., Carter, J.D., & Stough, C. (2004). An evaluation of the sensitivity of the Standardised Field 
Sobriety Tests (SFSTs) to detect impairment due to marijuana intoxication. Psychopharmacology 
(Berlin), 180, (1), 107-114.  
Pomahacova, B., Van der Kooy, F., & Verpoorte, R. (2009). Cannabis smoke condensate III: the 
cannabinoid content of vaporised Cannabis sativa. Inhalation Toxicology, 21, (13), 1108-12.  
Procon.org 28 Legal medical marijuana states and DC: laws, fees, and possession limits. 
http://medicalmarijuana.procon.org/view.resource.php?resourceID=000881 (accessed 12/21/16).  
Ramaekers, J.G., Berghaus, G., van Laar, M., & Drummer, O.H. (2004). Dose related risk of motor vehicle 
crashes after cannabis use. Drug & Alcohol Dependence, 73, (2), 109-119.  
Substance Abuse and Mental Health Services Administration (SAMHSA). (2014). Results from the 2013 
National Survey on Drug Use and Health: Summary of National Findings.  
United Nations Office on Drugs and Crime (UNODC). (2014). World Drug Report. United Nations 
Publication, Sales No. E.14.XI.7.  
Vandrey, R., Raber, J.C., Raber, M.E., Douglass, B., Miller, C., Bonn-Miller, M.O. (2015). Cannabinoid 
dose and label accuracy in edible medical cannabis products. Journal of the American Medical 
Association, 313, (24), 2491-2493.  
Vandrey, R., Cone, E.J., Herrmann, E.S., Mitchell, J.M., Flegel, R., LoDico, C., & Bigelow, G.E. (2015b). 
The pharmacodynamic dose effects of oral cannabis administration. Society of Forensic 
Toxicologists Annual Meeting, Atlanta, GA, October 18-23.  
Vandrey, R.G., & Mintzer, M.Z. (2009). Performance and cognitive alterations. In L. Cohen, F.L. Collins, 
A.M. Young, D.E. McChargue, & T.R. Leffingwell (Eds.), The Pharmacology and treatment of 


Date: May 18, 2018 
Principal Investigator: Vandrey, Ryan 
Application Number: IRB00122849 
JHMIRB eFormA  01 
Version 3 Dated:   8/15/05 
Page 18 of 18 
 
substance abuse: an evidence-based approach (pp. 41-62). Mahwah, NJ: Lawrence Erlbaum 
Associates, Inc.  
Walsh, Z., Callaway, R., Belle-Isle, L., Capler, R., Kay, R., & Lucas, P., Holtzman, S. (2013). Cannabis for 
therapeutic purposes: Patient characteristics, access, and reasons for use. International Journal of 
Drug Policy, 24, (6), 511-516.  
Zuurman, L., Roy, C., Schoemaker, R.C., Hazekamp, A., den Hartigh, J., Bender, J., Verpoorte, R., 
Pinquier, J.L., Cohen, A.F., & van Gerven, J.M.A. (2008). Effect of intrapulmonary 
tetrahydrocannabinol administration in humans. Journal of Psychopharmacology, 22, (7), 707- 716.  
 

ICF_001.pdf: 
Differences in Cannabis Impairment and its Measurement Due to Route of Administration
NCT03122691
6/5/2018


Approved June 5, 2018 
Date: June 5, 2018 
Principal Investigator: Ryan Vandrey, Ph.D. 
Application No.: IRB00122849 
Page 1 of 10 
Combined Informed Consent/Authorization June 2015 Version 15 
RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY 
AUTHORIZATION FORM 
Protocol Title:  
Differences in Cannabis Impairment and its Measurement Due to 
Route of Administration 
Application No.: 
IRB00122849 
Sponsor: 
National Institute of Justice (NIJ) 
Principal Investigator:  Ryan Vandrey, Ph.D. 
5510 Nathan Shock Dr. 
Baltimore, MD 21224 
Phone: 410-550-4036  
Fax: 410-550-0030 
1.
What you should know about this study:
•
You are being asked to join a research study. This consent form explains the research study and your
part in it. Please read it carefully and take as much time as you need. Ask your study doctor or the
study team to explain any words or information that you do not understand.
•
You are a volunteer.  If you join the study, you can change your mind later.  There will be no penalty
or loss of benefits if you decide to quit the study.
•
During the study, we will tell you if we learn any new information that might affect whether you
wish to continue to participate.
•
If we think your participation in this study may affect your clinical care, information about your
study participation will be included in your medical record, which is used throughout Johns Hopkins.
Doctors outside of Johns Hopkins may not have access to this information.  You can ask the research
team to send this information to any of your doctors.
•
When Johns Hopkins is used in this consent form, it includes The Johns Hopkins University, The
Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General Hospital,
Johns Hopkins Community Physicians, Suburban Hospital, Sibley Memorial Hospital and All
Children’s Hospital.
•
Biospecimens will be collected in this study.  Biospecimens may include any of the following:
blood, tissue, saliva, urine, bone marrow, cells, etc.  Most biospecimens contain DNA, which is the
genetic code for each person.
•
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by
U.S. Law.  This Web site will not include information that can identify you. At most, the Web site
will include a summary of the results. You can search this Web site at any time.
If you are using Epic for this study, fax a copy 
of the signed consent form to 410-367-7382. 
Patient I.D. plate 


 
Approved June 5, 2018 
Date: June 5, 2018 
Principal Investigator: Ryan Vandrey, Ph.D. 
Application No.: IRB00122849 
 
Page 2 of 10 
Combined Informed Consent/Authorization June 2015 Version 15 
• If you would like to review the information for this study, or a summary of the results, ask the study 
team doctor for the ClinicalTrials.gov study registration number. 
• During this study, you will not have access to certain medical information and test results collected 
for study purposes.  If an emergency occurs while you are in the study, medical information needed 
for your treatment can be made available to your study physician and other physicians who treat you.  
When the study is completed, all the information in your medical record will be available to you. 
 
2. 
Why is this research being done? 
This research is being done to measure the effects of both oral and vaporized cannabis (marijuana), at 
different doses, on your ability to perform certain tasks such as balancing, eye tracking, and 
computerized measures of memory and attention.  We will also collect biological fluids (urine, blood, 
saliva/spit) after cannabis is eaten or vaporized to see if there are markers in those fluids that can predict 
how you do on the tasks.  The results of this study will help us better understand the effects of using 
cannabis, and to help identify behaviors and/or substances in the body that relate to cannabis 
impairment.   
 
The use of cannabis in this research study is investigational.  The word “investigational” means that 
cannabis is not approved for marketing by the FDA and is still being tested in research studies.  The 
FDA is allowing the use of cannabis in this study. The cannabis used in this study has been provided for 
research purposes by the NIDA Drug Supply Program. 
 
People aged 18-45 years who have used cannabis previously, but not during the past 30 days, may join 
this study. 
 
How many people will be in this study? 
Up to 30 people will be enrolled in this study.  
 
3. 
What will happen if you join this study? 
If you agree to be in this study, we will ask you to do the following things: 
 
 
Screening  
You will be asked to answer some questions and complete some tests to see if you are eligible to take 
part in this study. This is called “screening” and will take about 3 hours to complete.  During the 
screening visit: 
• You will be asked to tell us about yourself (for example, your full name and date of birth) and to 
answer questions about your medical history and past use of legal and illegal drugs.   
• We will measure your weight, blood pressure, heart rate, and will conduct a routine physical 
examination.    
• You will be asked to give us urine, blood (5mL or 2 teaspoons), and saliva samples for testing and 
drug screening, and to give us a breath sample to see if you drank alcohol recently.  If you are 
female, the blood sample also will be tested to see if you are pregnant. Positive tests for drug use or 
pregnancy would make you ineligible for the study.  
• We will also obtain an electrocardiogram (ECG), which is a measure of how healthy your heart is.  
The ECG measures the electrical activity of your heart. The test involves putting small sticky 
electrodes, like Band-Aids®, on your chest. Sometimes these sticky electrodes are also put on your 
arms and legs.  
• You will be asked to answer questions about how you are feeling and have felt recently.  Most of the 
questions will be done on a computer, but some will be done as an interview.   
 


 
Approved June 5, 2018 
Date: June 5, 2018 
Principal Investigator: Ryan Vandrey, Ph.D. 
Application No.: IRB00122849 
 
Page 3 of 10 
Combined Informed Consent/Authorization June 2015 Version 15 
You will not be exposed to any study drug during the screening visit.   
 
If you are not eligible for this study, your study participation will end after the screening visit.  
 
Study 
If you are eligible for the study based on the screening, and decide to continue to take part in this study, 
participation will consist of the following things: 
 
• Study location  
The study will take place at the Johns Hopkins Bayview Medical Center (JHBMC).  You will be 
asked to come to JHBMC a total of 7 times: A 3-hour session for the screening assessment and six 1-
day drug administration sessions.  
 
• Study measures  
Each time you arrive at JHBMC for a screening or drug administration session, you will be asked to 
give us a urine sample for drug screening and to take a breath test to see if you have recently used 
alcohol.  If you are female, the urine sample also will be tested to see if you are pregnant.  Positive 
tests for alcohol, drug use, or pregnancy will disqualify you from the study at that time.   
 
While at JHBMC, you will be asked to answer questions about how you are feeling, complete tasks 
that test skills like attention, memory, thinking, reaction time, balance, eye tracking, and hand-eye 
coordination, have your vital signs (for example, heart rate, blood pressure) measured by research 
staff, and provide blood (6 mL; 1.2 teaspoons), urine, and saliva samples several times throughout 
each day.   
 
During the study, you will be asked to wear a device on your chest that measures the electrical 
activity of your heart and movement during the time you are here.  You will put this device on 
yourself or with the assistance of research staff.  It gets attached to you with 2 sticky electrodes.  
 
We will use an eye tracking video recorder to check your eye movements.  
 
For research purposes, a video recording will be made of the balance, eye tracking, and hand-eye 
coordination tasks that you complete. The purpose of this recording is to make sure that your ability 
to do these tasks is scored correctly. These recordings will be used for the purposes of this research, 
will be stored on password secured and encrypted computers, and will not be shared without your 
written permission.  
 
• Cannabis exposure 
You will be asked to self-administer cannabis during six drug administration sessions. For three of 
these sessions you will be asked to consume a chocolate brownie containing either placebo or one of 
two doses of cannabis (containing 10mg or 25mg THC). For the other three sessions, you will be 
asked to inhale vaporized cannabis containing placebo or one of two doses of cannabis (containing 
5mg or 20mg THC).  A placebo is a substance that looks like the study drug but that contains no 
active ingredients.  In this study we will compare the study drug to placebo.  The doses of cannabis 
used in this study are similar to the amount of found in about 1/10 to 1/4 gram of average potency 
(10% THC) cannabis.  One gram of cannabis is the amount commonly found in one cigarette (joint, 
blunt).  You will be given 5 minutes to eat each brownie and 10 minutes to inhale the vaporized 
cannabis. The dose of cannabis or placebo you receive is selected at random, like picking numbers 


 
Approved June 5, 2018 
Date: June 5, 2018 
Principal Investigator: Ryan Vandrey, Ph.D. 
Application No.: IRB00122849 
 
Page 4 of 10 
Combined Informed Consent/Authorization June 2015 Version 15 
out of a hat. You will not be told which dose you are given on any session day, and study staff will 
also not know this at that time.    
 
• Biological specimen collection 
We will collect some of your blood, urine, and saliva, at certain times.  A small amount of blood 
(6mL or 1.2 teaspoons) and saliva will be collected when you arrive and again several times 
throughout the day.  On days that cannabis is eaten, additional blood specimens will be collected 1, 
2, 3, 4, 5, 6, and 8 hours after you finish eating the brownie.  On days when cannabis is vaporized, 
additional blood specimens will be collected immediately after and 1, 2, 3, 4, 6, and 8 hours after 
you finish inhaling the cannabis vapor. A small catheter will be placed in your arm so that blood can 
easily be collected and only one needle stick is needed.  We will collect 60 mL of blood during each 
session.  The total amount of blood we collect during the study (288 mL) is less than what would be 
collected during a routine blood donation (473 mL).  Your body should be able to replace the blood 
that is collected quickly and without effects on your health.   
 
We will collect all urine that you produce while you are at JHBMC during the drug administration 
sessions.   
 
• Other drug use 
Please let us know if you plan to take any new over-the-counter or prescription medication, or 
change the dose of any medication that you already take while you are in the study.  You will also be 
asked not to use any illegal drugs, including cannabis not provided to you as part of the study, until 
you have completed all study visits.   
 
If your urine drug test is positive for any drug when you arrive at JHBMC for your study visit, you 
will no longer be allowed to take part in this study.   
 
How long will you be in the study? 
Following the screening visit, if you are eligible, you will be asked to complete 6 drug 
administration sessions spaced about 1 week apart.  For each of those sessions you will be asked to 
spend about 10 hours (about 7:30am-5:30pm) at JHBMC. 
 
4. 
What are the risks or discomforts of the study? 
Cannabis 
Cannabis can cause a number of effects and include getting dizzy, loss of balance, change in heart rate 
or blood pressure, red or irritated eyes, feeling tired, pounding in chest or heart, dry mouth, jitters, 
headache, upset stomach, vomiting, sore throat, increased appetite, trouble concentrating, memory 
problems, confusion, depression, feeling paranoid, rash, trouble sleeping, blurry vision, ringing in the 
ears, diarrhea, and hallucinations. Vaporizing cannabis can also produce throat irritation.  Smoking 
cannabis may cause respiratory problems and harm, including bronchitis, emphysema and laryngitis, and 
increase risk for cancers of the mouth and lungs.  It is believed that vaporization reduces this risk 
relative to smoking, but harm associated with inhalation remains possible.  Cannabis is not known to 
cause overdose or death. 
 
During the telephone interview, you described yourself as having previously used cannabis, but that you 
have not used it in the past 30 days.  If you quit using cannabis because you had problems related to use 
in the past, exposure to cannabis in this study might create an increased desire to begin using it again. 
 


 
Approved June 5, 2018 
Date: June 5, 2018 
Principal Investigator: Ryan Vandrey, Ph.D. 
Application No.: IRB00122849 
 
Page 5 of 10 
Combined Informed Consent/Authorization June 2015 Version 15 
Use of cannabis has been associated with an increased risk of developing serious mental health problems 
such as psychosis and schizophrenia, especially for people with a family history of those types of 
problems.  There may be additional risks related to the use of cannabis that are not currently known. 
You should consider these risks before agreeing to take part in this study.  
 
Other risks or discomforts 
The risks of answering the questions and completing tasks in this study are not greater than the risks of 
everyday life.  You may get tired or bored when we are asking you questions or you are doing tasks. 
You do not have to answer any question you do not want to answer.   
 
The device used to measure the electrical activity of your heart should not be used by people who have a 
pacemaker or heart defibrillator.  If you have either one of these devices, please let us know right away 
so we know not to attach this device to you. 
 
Taking blood may cause discomfort, bleeding or bruising where the needle enters the body. In rare 
cases, it may result in fainting. There is a small risk of infection.  We will use sterile equipment to 
collect blood from you, reducing the risk of infection.  Steps will be taken to minimize discomfort.     
 
If you are subject to random drug testing as a condition of your employment, it is possible your 
participation in this study could cause a positive drug test. 
 
There may be side effects and discomforts that are not yet known.   
 
5. 
Are there risks related to pregnancy? 
If you are pregnant, you will not be able to take part in this study.  You must be willing to take a   
pregnancy test during the screening visit and on arrival at JHBMC for the study. 
 
6. 
Are there benefits to being in the study? 
There is no direct benefit to you from being in this study.  By taking part in this study you will help us 
better understand the effects of cannabis exposure, and under what conditions and for how long that may 
impact different types of drug testing. 
 
7. 
What are your options if you do not want to be in the study? 
This is a voluntary research study.  You do not have to join this study.  If you do not join, your care at 
Johns Hopkins will not be affected. 
 
8. 
Will it cost you anything to be in this study?   
The only cost to you for being in this study is the cost of traveling between your home and the Johns 
Hopkins Bayview campus.   
 
9. 
Will you be paid if you join this study? 
You will be paid for being in this study.  You will be paid $30 for completing the screening visit and an 
additional $2300 for completing the entire study.  Total possible earnings will be $2330.  A more 
detailed breakdown of study compensation is displayed below. 
  
                       Screening Visit:    $30 
Drug Administration Sessions: $300/completed session 
Completion Bonus: $500 
 $2330 


 
Approved June 5, 2018 
Date: June 5, 2018 
Principal Investigator: Ryan Vandrey, Ph.D. 
Application No.: IRB00122849 
 
Page 6 of 10 
Combined Informed Consent/Authorization June 2015 Version 15 
 
If you show up for the study and have a positive test for drugs, pregnancy, or alcohol, you will not be 
allowed to take part and you will not be paid for that visit.   
 
If you leave the study before completion, you will only be paid for study days that were completed prior 
to the day you leave the study and you will not receive the completion bonus.  
 
You may be required to provide your social security number to be paid for taking part in this study. 
Federal tax law requires that you report your research payments when you file your taxes. If your total 
payments from Johns Hopkins exceed $600 per year, Johns Hopkins will report these payments to the 
Internal Revenue Service and you will receive a 1099-MISC form from us. 
 
10. 
Can you leave the study early? 
• You can agree to be in the study now and change your mind later. 
• If you wish to stop, please tell us right away. 
• Leaving this study early will not stop you from getting regular medical care.  
 
If you leave the study early, Johns Hopkins may use or give out your health information that it has 
already collected if the information is needed for this study or any follow-up activities.  
 
11. 
Why might we take you out of the study early?  
You may be taken out of the study if: 
• Staying in the study would be harmful. 
• You need treatment not allowed in the study. 
• You fail to follow instructions. 
• You become pregnant. 
• The study is cancelled. 
• There may be other reasons to take you out of the study that we do not know at this time.  
 
If you are taken out of the study early, Johns Hopkins may use or give out your health information that it 
has already collected if the information is needed for this study or any follow-up activities. 
 
12. 
How will your privacy be protected?  
We have rules to protect information about you.  Federal and state laws and the federal medical Privacy 
Rule also protect your privacy.  By signing this form you provide your permission, called your 
“authorization,” for the use and disclosure of information protected by the Privacy Rule. 
 
The research team working on the study will collect information about you.  This includes things learned 
from the procedures described in this consent form.  They may also collect other information including 
your name, address, date of birth, and information from your medical records. This could include 
information about HIV and genetic testing, or treatment for drug or alcohol abuse or mental health 
problems. 
 
The research team will know your identity and that you are in the research study. The JHU IRB may 
need access to study records to ensure the welfare of study participants. People outside of Johns Hopkins 
(Federal government agencies such as the Food and Drug Administration, the Drug Enforcement 
Administration, and the Office of Human Research Protections) may need to see or receive your 
information for this study. This can be part of routine monitoring or audit of research studies, for 
protection of human subjects in research, or in response to a problem with this study. 


 
Approved June 5, 2018 
Date: June 5, 2018 
Principal Investigator: Ryan Vandrey, Ph.D. 
Application No.: IRB00122849 
 
Page 7 of 10 
Combined Informed Consent/Authorization June 2015 Version 15 
We cannot do this study without your authorization to use and give out your information.  You do not 
have to give us this authorization.  If you do not, then you may not join this study. 
 
We will use and disclose your information only as described in this form and in our Notice of Privacy 
Practices. 
 
The use and disclosure of your information has no time limit. You may revoke (cancel) your permission 
to use and disclose your information at any time by notifying the Principal Investigator of this study by 
phone or in writing.  If you contact the Principal Investigator by phone, you must follow-up with a 
written request that includes the study number and your contact information.  The Principal 
Investigator’s name, address, phone and fax information are on page one of this consent form.  
 
If you do cancel your authorization to use and disclose your information, your part in this study will end 
and no further information about you will be collected. Your revocation (cancellation) would not affect 
information already collected in the study, or information we disclosed before you wrote to the Principal 
Investigator to cancel your authorization. 
 
13. 
Will the study require any of your other health care providers to share your health 
information with the researchers of this study? 
As a part of this study, the researchers may ask to see your health care records from your other health 
care providers.   
 
14. 
Are there additional privacy protections?  
The identifiable data collected in this study can only be used for research purposes, and no other purpose 
without your consent. (42 USC 3789g) The researchers have an approved Privacy Certificate from NIJ 
that protects the data collected in this study. (28 CFR Part 22) This means that the identifiable 
information collected from you is immune from legal process, cannot be released by the researchers 
under subpoena, and can not be admitted as evidence or used for any purpose in any action, suit, or other 
judicial, legislative, or administrative proceedings without your consent. De-identified data from this 
study will be archived at the National Archive of Criminal Justice Data (NACJD). 
 
Confidentiality can be broken if you indicate to us that you intend to harm yourself or someone else or if 
we suspect abuse, neglect or abandonment of a child or vulnerable adult. In such a situation, we may 
need to intervene or to report this to the appropriate authorities. For us to make a report, your consent for 
reporting is needed. Please see the separate consent for reporting. If you do not sign the consent for 
reporting, you may not participate in this study. 
 
15. 
What treatment costs will be paid if you are injured in this study?  
Johns Hopkins and the federal government do not have programs to pay you if you are hurt or have 
other bad results from being in the study.  However, medical care at Johns Hopkins is open to you as it 
is to all sick or injured people.   
 
The costs for any treatment or hospital care you receive as the result of a study-related injury that are not 
covered by a health insurer will be billed to you. 
 
By signing this form you will not give up any rights you have to seek compensation for injury. 
 
 
 


 
Approved June 5, 2018 
Date: June 5, 2018 
Principal Investigator: Ryan Vandrey, Ph.D. 
Application No.: IRB00122849 
 
Page 8 of 10 
Combined Informed Consent/Authorization June 2015 Version 15 
16. 
What other things should you know about this research study? 
a. What is the Institutional Review Board (IRB) and how does it protect you?  
The Johns Hopkins Medicine IRB is made up of: 
• Doctors 
• Nurses 
• Ethicists 
• Non-scientists 
• and people from the local community.  
 
The IRB reviews human research studies. It protects the rights and welfare of the people taking part 
in those studies.  You may contact the IRB if you have questions about your rights as a participant or 
if you think you have not been treated fairly.  The IRB office number is 410-955-3008. You may 
also call this number for other questions, concerns or complaints about the research.  
 
When the Johns Hopkins School of Medicine Institutional Review Board (IRB) reviews a study at 
another site, that site (institution) is solely responsible for the safe conduct of the study and for 
following the protocol approved by the Johns Hopkins IRB.   
 
b. What do you do if you have questions about the study?    
Call the principal investigator, Dr. Ryan Vandrey at 410-550-4036 (office) or 802-310-7956 (cell). If 
you wish, you may contact the principal investigator by letter or by fax. The address and fax number 
are on page one of this consent form.  If you cannot reach the principal investigator or wish to talk to 
someone else, call the IRB office at 410-955-3008.  
  
c. What should you do if you are injured or ill as a result of being in this study?  
If you think you are injured or ill because of this study, call Dr. Annie Umbricht at 410-550-1917 
during regular office hours.  
 
If you have an urgent medical problem related to your taking part in this study, call the on-call 
physician at 410-550-0052 during regular office hours, after hours, and on weekends.  
 
In the event of an emergency, please call 911 right away and then call Dr. Umbricht at 410-
550-1917 and Dr. Vandrey at 410-550-4036 after you have received emergency care.  
 
d. What happens to Data and Biospecimens that are collected in the study?  
Johns Hopkins and our research partners work to understand and cure diseases. The biospecimens 
and/or data you provide are important to this effort. 
 
If you join this study, you should understand that you will not own your biospecimens or data, and 
should researchers use them to create a new product or idea, you will not benefit financially.  
 
With appropriate protections for privacy, Johns Hopkins may share your biospecimens and 
information with our research sponsors and partners.    
 
 
 


 
Approved June 5, 2018 
Date: June 5, 2018 
Principal Investigator: Ryan Vandrey, Ph.D. 
Application No.: IRB00122849 
 
Page 9 of 10 
Combined Informed Consent/Authorization June 2015 Version 15 
17. 
What does your signature on this consent form mean?  
Your signature on this form means that: 
• you understand the information given to you in this form  
• you accept the provisions in the form 
• you agree to join the study  
 
You will not give up any legal rights by signing this consent form.  
 
 
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM 
 
________________________________________________________________________________________________________________________ 
Signature of Participant                                                                           (Print Name)                                                 
 
Date/Time  
 
 
________________________________________________________________________________________________________________________ 
Signature of Person Obtaining Consent                                                  (Print Name)                                               
 
Date/Time 
 
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE 
PRINCIPAL INVESTIGATOR; A COPY MUST BE GIVEN TO THE PARTICIPANT; IF YOU ARE 
USING EPIC FOR THIS STUDY A COPY MUST BE FAXED TO 410-367-7382; IF YOU ARE NOT 
USING EPIC A COPY MUST BE PLACED IN THE PARTICIPANT’S MEDICAL RECORD (UNLESS 
NO MEDICAL RECORD EXISTS OR WILL BE CREATED).  
 
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE 
USED TO OBTAIN THE CONSENT OF RESEARCH PARTICIPANTS. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
Approved June 5, 2018 
Date: June 5, 2018 
Principal Investigator: Ryan Vandrey, Ph.D. 
Application No.: IRB00122849 
 
Page 10 of 10 
Combined Informed Consent/Authorization June 2015 Version 15 
DOCUMENTATION OF PHYSICIAN/MID-LEVEL PROVIDER CONSENT 
 
My signature below indicates that I have discussed the risks, benefits, and alternatives, answered any 
questions, and believe the participant is able to make an informed choice to join the study. 
 
 
________________________________________________________________________________________________________________________ 
Signature of Physician/Mid-Level Provider                     (Print Name)                                                                     
 
Date/Time   
 
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Participant                                                    (Print Name)                                                                    
 
Date/Time     
 
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR; A COPY 
MUST BE GIVEN TO THE PARTICIPANT; IF YOU ARE USING EPIC FOR THIS STUDY A COPY MUST BE FAXED TO 410-367-
7382; IF YOU ARE NOT USING EPIC A COPY MUST BE PLACED IN THE PARTICIPANT’S MEDICAL RECORD (UNLESS NO 
MEDICAL RECORD EXISTS OR WILL BE CREATED).  
 
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO OBTAIN THE CONSENT 
OF RESEARCH PARTICIPANTS.