Clinical trial NCT04269993
Conditions: Rheumatoid Arthritis Psoriatic Arthritis
Sponsor: Brown University
Start date: 2022-05-18; Completion date: 2023-07-31
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This laboratory study will investigate the impact of cannabis on pain, affect, and inflammation among patients with rheumatoid or psoriatic arthritis (n = 76). Two cannabis formulations varying in potency will be administered via vaporization across two experimental sessions using a counter-balanced, double-blind, crossover design.

Detailed description:
This laboratory study will investigate the impact of cannabis on pain, affect, and inflammation among patients with rheumatoid or psoriatic arthritis (n = 76). Two cannabis formulations varying in potency will be administered via vaporization across two experimental sessions using a counter-balanced, double-blind, crossover design. Blood will be collected during each session (pre-vaporization, 10 minutes post-vaporization, 60 minutes post-vaporization). Self-reported pain and affect will be assessed at the same time points. The effect of cannabis on pain, affect, and inflammatory biomarkers will be assessed. The study will recruit 76 patients to obtain a final sample of 66 with complete data (15% attrition). This study will be the first to investigate the effect of cannabis on pain, affect, and markers of inflammation among patients with rheumatoid or psoriatic arthritis. This study has the potential to guide clinical decisions pertaining to use of cannabis to treat arthritis symptoms with more precise recommendations regarding cannabis formulation.

Arms: arm 1: Participants are randomized to receive placebo cannabis during Session 1 and Active THC cannabis during Session 2; sessions will be separated by at least 2 days arm 2: Participants are randomized to receive Active THC cannabis during Session 1 and placebo cannabis during Session 2; sessions will be separated by at least 2 days
Interventions: intervention 1: Cannabis: placebo and medium THC/medium CBD
Intervention descriptions: intervention 1: Vaporized cannabis was administered to participants (placebo and medium THC/medium CBD).

Protocol documents:
Prot_SAP_000.pdf: 
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Cover page 
Official Title of Study: Impact of Cannabis on Pain and Inflammation Among Patients with Rheumatoid or 
Psoriatic Arthritis 
ClinicalTrials.gov Identifier: NCT04269993 
Document Type: Protocol and Statistical Analysis Plan dated 4/7/2022 
Subtitle: N/A 
(The informed consent form document(s) uploaded in Portable Document Format Archival (PDF/A) format. It 
is strongly encouraged that the PDF/A file also be consistent with the PDF Universal Accessibility (PDF/UA) 
format, to optimize accessibility). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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RESEARCH PROTOCOL 
 
Principal Investigator: 
 
Elizabeth R. Aston, Ph.D. 
 
 
 
 
 
 
Brown University School of Public Health 
 
 
 
 
 
 
Center for Alcohol and Addiction Studies 
 
 
 
 
 
 
121 South Main Street, 5th Floor, Providence, RI 02912 
 
 
 
 
 
 
 
Primary Mentor/Co-Investigator: Jane Metrik, Ph.D., Brown University  
 
Project Title:  
 
 
Impact of Acute Cannabis Administration on Pain Symptomology  
 
 
 
 
 
and Inflammatory Markers among Patients with Rheumatoid or  
 
 
 
 
 
Psoriatic Arthritis 
 
NIGMS Grant #: 
 
 
P20GM130414 
Authority: 
 
 
 
This study has been approved by the Brown University Institutional  
Review Board  
 
 
 
 
 
 
 
____________ 
 
 
 
 
 
 
A. RATIONALE AND OVERVIEW 
Approximately 25 million adults in the United States report experiencing daily chronic pain 1. The majority of 
these patients use pharmacotherapies, including opioids, to alleviate negative physiological and psychological 
symptoms associated with pain. However, while analgesic pharmacotherapy has efficacy in pain treatment, 
some classes of medications (e.g., opioids) have significant abuse liability. Moreover, patients frequently report 
ongoing experience of chronic pain symptoms despite these treatments. For some conditions, patients have 
sought alternative therapies, including cannabis, to alleviate negative symptoms. Between 45% and 80% of 
those who use cannabis for medicinal purposes do so for pain management 2,3. Self-report surveys on use of 
cannabis for medical purposes suggest that it improves pain, sleep, and negative mood, with modest side effects 
4,5. Indeed, randomized controlled trials (RCTs) indicate that cannabis may be an effective pharmacotherapy for 
certain chronic pain diagnoses, including multiple sclerosis 6,7, neuropathic pain 8, and cancer-related pain 9. 
However, there is a dearth of well-controlled research on use of cannabis to treat symptoms associated with 
inflammatory conditions such as rheumatoid arthritis (RA) or Psoriatic Arthritis (PA). RA is a chronic 
inflammatory disease that affects approximately 1.3 million Americans, which is increasing as the US 
population ages 10. RA is characterized by joint destruction, stiffness, swelling and pain, leading to loss of 
function 11. In addition, key cytokines, or pro-inflammatory secreted proteins, are involved in joint injury 
associated with RA 12; specifically, TNF-α and IL-1. Pre-clinical studies indicate that cannabinoids demonstrate 
promising anti-arthritic properties in both human cells from RA patients and animal models of RA 13. 
Preclinical research has shown that cannabinoids are strong anti-inflammatory ligands and function via 
induction of apoptosis, inhibition of cell proliferation, and suppression of cytokine production 14. Only one 
clinical study has investigated the effect of a cannabis plant derivative comprised of an equal ratio of two 
cannabinoids (i.e., Δ⁹-tetrahydrocannabinol [THC] and cannabidiol [CBD]), in oromucosal form, on pain 
related to RA, and reported promising results 15. Therefore, more research in this area is critical. Whole plant 
cannabis may be more effective than synthetic and partial formulations to treat chronic pain conditions, 
purportedly due to its composition of hundreds of distinct cannabinoids that work in synergy to alleviate 
symptoms 16. In addition to THC, which has been shown to reduce several types of chronic pain, CBD may be 
particularly effective in reducing negative symptomology in RA patients due to its anti-inflammatory properties 
13,17.  
 
B.1. SPECIFIC AIMS 
This proposal will investigate the impact of whole plant cannabis on pain, affect, and inflammation among RA 
patients (n = 66). We will administer two cannabis formulations via vaporization (placebo and medium THC 
[3.6%]/medium CBD [5.4%]) across two experimental sessions using a counter-balanced, double-blind, 
crossover design. THC doses in the medium potency range will be tested in combination with CBD in the 


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medium potency range. With respect to inflammation outcomes, prior studies have demonstrated efficacy of 
cannabis with a 1:1 ratio of THC:CBD. Therefore, we hypothesize that cannabis in the medium THC potency 
range in combination with medium potency CBD will decrease inflammatory biomarkers relative to placebo.  
 
Aim 1. To determine whether cannabis acutely reduces pain and negative affect as compared to placebo.  
a. We hypothesize that, relative to placebo, cannabis (medium THC/medium CBD will decrease subjective 
reports of pain. 
b. We hypothesize that, relative to placebo, cannabis (medium THC/medium CBD) will decrease 
subjective reports of negative affect. 
c. We hypothesize that blood THC and CBD levels will be negatively correlated with subjective reports of 
pain and negative affect. 
Aim 2. To determine whether cannabis acutely reduces markers of inflammation (IL-1α, IL-1β, IL-6 and TNF-
α) as compared to placebo.  
a. We hypothesize that, relative to placebo, cannabis (medium THC/medium CBD) will decrease blood 
markers of inflammation. 
b. We hypothesize that inflammation marker levels will be positively correlated with subjective reports of 
pain and negative affect, and negatively correlated with blood THC and CBD levels.  
 
B.2. SAMPLE DESCRIPTION AND RECRUITMENT 
Human subject involvement is necessary to complete this research proposal (n = 66). This proposal will require 
patients with rheumatoid arthritis (RA) or psoriatic arthritis (PA) to participate in laboratory cannabis 
administration sessions. Patients will be initially screened by phone or at the clinic, followed by a rigorous 
medical and diagnostic screening at intake. We describe recruitment procedures, inclusion criteria for 
participation, rationale for the proposed population, and retention strategies below. 
 
Participants will be recruited from rheumatology clinics in Rhode Island (Brown University Physician 
outpatient clinic and the Chapman Street Outpatient Clinic of Rhode Island Hospital) and Massachusetts via 
initial contact by providers involved in the patient's care, flyers, advertisements, mailings, and referral. Potential 
subjects will be screened via phone, online screener, or at the clinic. Eligible subjects will be scheduled to meet 
briefly via videocall to provide consent, and then will be scheduled for an initial baseline laboratory visit.  
Participants may be asked to fill out a HIPAA Authorization Form to facilitate confirmation of RA/PA 
diagnosis. We will include subjects with a range of baseline pain levels to capitalize on variability, and baseline 
VAS pain score will be used as a covariate in all analyses. Participants will be enrolled in the study using the 
following inclusion criteria: 
 
Inclusion Criteria:  
a) current RA or PA diagnosis with active arthritis not adequately controlled by standard medication (i.e., 
self-report pain levels at or above 30/100 on a visual analog scale (VAS) pre-study enrollment) 
b) if taking prescribed steroid, non-steroidal anti-inflammatory (NSAID), and/or disease-modifying anti-
rheumatic drugs (DMARDS; e.g., tumor necrosis factor inhibitors), must be stable use for at least 1 
month prior to enrollment (all must be maintained throughout the study)  
c) English-speaking or Spanish-speaking 
d) negative urine toxicology screen for cannabis and other drugs (opiates with prescription allowed; may 
not be used the morning of the study) 
e) negative pregnancy test  
f) not nursing  
g) use of highly effective birth control during the study for both males and females  
h) prior history of vaping or smoking cannabis with similar to that being used in the current investigation 
(i.e. cannabis use via smoking or vaping at least once in lifetime) 
 
Exclusion Criteria: 


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i) greater than zero breath alcohol concentration 
j) presence of a DSM-5 diagnosis of psychosis or panic disorder as assessed by the Mini International 
Neuropsychiatric Interview (MINI) and not suicidal [past month ideation or intent] 
k) self-report of serious adverse reaction to cannabis in the past year 
l) smoking more than 20 tobacco cigarettes per day  
m) body mass index below 18.0 or above 33.0 kg/m2 range confirmed during medical exam (as extreme 
BMIs can influence drug blood levels and BMIs in the obese range are considered cardiovascular risk 
factors) 
n) all current asthma conditions (i.e., active symptomatic asthma within the last week) or current or past 
history of asthma triggered by smoking or vaping 
o) current diagnosis of dementia or Parkinson’s disease 
p) scores below 23 on the Folstein Mini-Mental Status Exam 
q) current diagnosis of moderate to severe traumatic brain injury 
r) current diagnosis of epilepsy 
s) individuals who are immunocompromised (i.e., post-organ transplant, those with an immune deficiency 
disorder such as HIV, individuals taking immunosuppressant steroids such as continuous prednisone 
use, and those with lupus) 
t) past kidney disease (e.g., glomerular nephritis, polycystic kidney disease) and/or presence of elevated 
creatinine (levels above 2.0)  
u) cardiac disease confirmed via clinically significant abnormal findings on an EKG (e.g., arrhythmia, 
conduction abnormalities, ischemia, or evidence of past myocardial infarction), as well as diagnoses of 
congestive heart failure or cardiomyopathy  
v) abnormal vital signs (heart rate will be required to be below 50 or above 110 BPM; blood pressure 
above 160/100 or below 90/60; blood oxygen levels below 90%) 
w) taking any medications on our List of Exclusionary Medications 
x) presence of any severe cardiovascular, renal, or hepatic disorder 
y) below 18 or above 65 years of age  
z) use of cannabis in the past 1 month before commencement of study participation and throughout the 
study as confirmed via urine toxicology screening  
aa) below minimum self-reported pain level of 30/100 on a visual analog scale (VAS) pre-study enrollment 
via telephone and at baseline due to potential variability in pain level 
 
B.3. RECRUITMENT METHODS 
We plan to recruit RA patients primarily from the Brown University Physician outpatient clinic and the 
Chapman Street Outpatient Clinic of Rhode Island Hospital. Approximately 9,000 patients with various 
rheumatic conditions and approximately >3,000 with rheumatoid arthritis visit these clinics annually. With the 
facilitation of our collaborators (please see letter of support), participants will be recruited via initial contact by 
providers involved in the patient's care, flyers, advertisements, mailings, and referral. Potential subjects will be 
screened via phone. 
 
Primarily, we will receive referrals from our collaborators at the Brown University Physician outpatient clinic. 
In addition, we will use internet advertisements on social media sites and flyers at local treatment clinics. The 
study PI and research assistant (both having completed all required CITI certifications) will be contacted by our 
collaborators in the instance of referrals, and by other interested patients with rheumatic disease (rheumatoid 
and psoriatic arthritis). Potential participants will be screened in person at the clinic, or via telephone or online 
screener. Potential participants will primarily be referred by our collaborators. Patients that meet eligibility 
criteria, are not well-controlled on current medications, and are deemed to potentially benefit from 
incorporating cannabis into their treatment regimen will be enrolled in the study.  
While use of cannabis to treat chronic pain associated with various conditions (e.g., inflammatory rheumatic 
diseases) is approved in Rhode Island and many other states, there is limited research in this area and it is not 


5 
 
the standard of care for such diseases. Of note, the cannabis that will be administered in the current 
investigation will be an adjunct to current approved treatment regimen.  
 
At baseline session conclusion, eligible participants will be scheduled for two 5-hour experimental CB 
administration sessions and randomized to either placebo or medium THC/medium CBD dose for Experimental 
Session 1 and will receive the other dose at the following session (Experimental Session 2). The study PI will 
randomize participants to the dose conditions but will not run experimental sessions. In order to maintain 
double-blind conditions, CB will be prepared by a pre-designated staff member with DEA clearance. 
Participants and other study staff working directly with participants will be blind to dose. To control for 
expectancy effects18,19, participants will be told they will vaporize CB varying in THC in the low to moderate 
potency range. CB appearance is identical across dose. 
 
Compensation/Reimbursement: Participants will be compensated $50 for the baseline session, $100 for each 
of two cannabis administration sessions, and will receive an additional $50 bonus for completion of all 
experimental sessions for a maximum total of $300. Ineligible subjects will be paid $10 and excluded from 
participation. Due to experimental sessions involving cannabis administration, participants will be transported 
home following each experimental session via taxi, Uber, or other rideshare service.  
 
B.4. METHODOLOGY 
Synopsis. This study will be the first to investigate the effect of vaporized CB on pain, affect, and markers of 
inflammation among patients with RA. This research will be conducted over two Aims. Aim 1: To determine 
whether CB acutely reduces RA-associated pain and negative affect as compared to placebo. Aim 2: To 
determine whether CB acutely reduces markers of inflammation (IL-1α, IL-1β, IL-6 and TNF-α) as compared to 
placebo. Using a randomized, placebo-controlled, crossover design, participants (n = 66) will vaporize CB 
(placebo and medium THC/medium CBD) over two experimental sessions. Blood will be collected during each 
session (pre-vaporization, 10 min post-vaporization, 60 min post vaporization). Self-reported pain and affect 
will be assessed at the same time points.     
 
Baseline Session: Following online/phone screening, potential subjects will meet remotely with research staff 
for a videocall to complete the study consent forms and discuss any questions. Participants will then attend an 
in-person baseline screening session at the laboratory to confirm eligibility and complete a physical exam. They 
will be asked to refrain from alcohol for 24 hours and caffeine for 2 hours prior to experimental sessions. 
Subjects will complete an alcohol breathanalysis for breath alcohol concentration (BrAC), and urine drug screen 
and pregnancy test (females). Subjects with a positive BrAC will be rescheduled. Tobacco smokers will be 
permitted to smoke a cigarette following the CO test to prevent nicotine withdrawal. Subjects will be 
administered a medical screening questionnaire to rule out history of adverse reaction to CB, and the MINI to 
make diagnostic exclusions of suicidality and key DSM-5 diagnoses (psychosis, panic disorder).  
 
Eligible subjects will complete baseline measures and a physical exam conducted by physician or nurse 
practitioner to determine medical clearance prior to the CB administration sessions. The physical exam will 
include assessment of heart rate, blood pressure, and blood oxygen levels. Vital signs will be assessed again at 
the beginning of each experimental session. During the physical exam, a medical history will be obtained, blood 
will be drawn, and an EKG will be performed. To assess severe renal disease, the nurse practitioner will ask 
about any past kidney disease (e.g., glomerular nephritis, polycystic kidney disease), and blood will be tested 
for presence of elevated creatinine. The physical exam will also include physical function testing pertaining to 
RA/PA: self-selected gait speed, 5-chair rise test, single leg stance test20,21.  
 
To confirm that participants are not currently experiencing cognitive impairment at the commencement of study 
participation, they will complete the Folstein Mini-Mental Status Exam (MMSE; Folstein et al., 1975) which 
includes 30 items to assess cognitive impairment on a scale from 30 (no impairment) to 0.  
 
Psychoactive and pain-relieving effects of CB are acute, thus experimental sessions will be separated by at least 


6 
 
two days. No subjective or behavioral effects will last past CB administration in the laboratory. Urine screens 
may test positive for CB at session 2 (if active dose was administered at session 1), however, we confirm no 
recent smoking via CO test, thus urine screens that are positive for THC are irrelevant.  
 
Experimental CB Administration Sessions (1-2): Information including medications and pain level will be 
reconfirmed the morning of experimental sessions to maintain study eligibility. At each experimental session, 
BrAC and carbon monoxide (CO) level will be tested to confirm no recent alcohol or CB use. CO level must be 
8ppm or below in order to proceed with the session; levels that are higher than 8ppm may be given some time 
to decrease to 8ppm (i.e. we will re-test) at the PI's discretion. Cigarette smokers will be given an opportunity 
for a smoking break after the test if they would like. Subjects will complete urine toxicology screening to 
confirm no other drug use. Females will be tested for pregnancy at each session. Vital signs will be obtained. 
Subjects will consume a calorie-controlled breakfast and complete pre-administration measures and 
questionnaires, an automatically inflating blood pressure (BP) cuff will be secured to continuously record heart 
rate and BP during the entire experimental session, and blood collection procedures will be implemented (see 
Figure 1). Participants will complete physical function testing20,21. Participants will then vaporize the assigned 
CB dose and complete post-administration subjective measures of pain, affect, and drug effects. CB 
vaporization procedures will begin at 11am in order to reduce variability in pain that may occur throughout the 
day. Subjects will vaporize CB using a Storz & Bickel MIGHTY Vaporizer apparatus. Approximately 250mg 
CB will be ground to maximize surface area and will be placed in the vaporizer. The vaporizer will be prepared 
exclusively by study staff or the PI. Using the step-by-step quick-start guide and manual, study staff will 
prepare the vaporizer and will give it to the participant. The vaporizer device will be used on a dry surface away 
from paper and other flammable substances. A cued-puff procedure22 will standardize CB administration. 
Participants will listen to an audio-recording that will signal them to “get ready” (5 seconds), “inhale” (5 
seconds), “hold vapor in lungs” (10 seconds), “exhale,” and to wait before repeating the inhalation cycle (40 
seconds). A research assistant and the study nurse will continuously monitor the subject during the vaporization 
session via two-way mirror. In our previous studies which employed the paced-puffing procedure for 
combustible CB cigarettes with similar THC levels, all participants were able to complete an entire cigarette in 
9 puffs in 8 mins on average18,19. All participants will be required to complete 9 inhalations according to 
standardized procedures. Following cannabis administration (peak effects at 20-min post vaporization), 
participants will complete assessments including pain and affect. Peak THC/CBD levels will be assessed. Pain 
and affect will continue to be assessed three times over the recovery period at 1-hour intervals. 
 
 
 
Blood Sampling Procedures: We will collect blood at 3 time-points during each experimental session for 
analysis of inflammatory biomarkers (i.e., IL-1α, IL-1β, IL-6, IL-10, IL-17A, TNF-α, INFɣ, MCP1, BDNF;  
sCD14); whole blood for future genetic analysis, if the participant consents to that portion; cannabinoid plasma 
levels (i.e., THC and CBD) pre-CB administration, at the termination of the CB administration procedure (10 
mins post-completion of CB administration), and 60 mins post-completion of CB administration. These time-
points were selected to characterize the impact of acute CB administration on pain and affect immediately 
following administration and at a delayed time-point (60-minutes post completion) to assess the duration of 
analgesia. Individual blood draws will be conducted in an antecubital vein at each pre-designated time point 
(see Figure 1). Blood samples will be collected in heparinized tubes (0.15 μl heparin) and placed on ice 
immediately after each blood draw. Within 15 minutes of collection, blood will be centrifuged and plasma will 
110 min 
105 min 
Controlled 
paced puff 
vaporization 
procedure 


7 
 
be transferred to a microtube and stored at -30ºC. Plasma will be analyzed for inflammatory biomarkers and 
cannabinoid levels using gas chromatography/mass spectrometry (GC-MS) techniques.  
 
Blood samples taken at the baseline/physical exam will be analyzed: i.e. IL-1α, IL-1β, IL-6, IL-10, IL-17A, 
TNF-α, INFɣ, MCP1, BDNF; sCD14; CRP; cannabinoid plasma levels (i.e., THC and CBD); creatinine, AST, 
ALT; whole blood for future genetic analysis (if the participant consents to that portion, as it is optional) 
 
Blood samples taken at the experimental sessions will be analyzed: i.e. THC, CBD, IL-1α, IL-1β, IL-6 and 
TNF-α, sCD14, CRP 
 
Sobriety Assessment: Subjects will remain in the laboratory for 3-hours following CB vaporization 
(psychotropic effects taper off within 2-3 hours24), during which time snacks and water will be provided. Vital 
signs will be monitored and resumption of normal vital signs will be required for discharge. Subjects will then 
be evaluated for motor signs of intoxication. To ensure there are no residual cannabis effects 3 hours post-
vaporization, participants will complete and pass a field sobriety test (i.e., heel-to-toe walking test, single leg 
raise balance test)25. Following successful completion of the field sobriety test, subjects will be transported 
home via train, taxi, rideshare, or with a responsible adult to avoid driving following CB use. In the event of a 
failed test, participants will remain in the laboratory 20 more minutes until repeat testing is completed and 
passed.  
 
Discharge Criteria: Participants will be permitted to leave the laboratory three hours following vaporization 
and only following a 75% reduction in their peak heart rate level during the experimental session. Blood 
pressure will be required to return to baseline ranges (below 160/100 and above 90/60).  To ensure there are no 
residual cannabis effects 3 hours post vaporization, participants will complete and pass a field sobriety test (i.e., 
heel-to-toe walking test, single leg raise balance test). In the event of a failed test, participants will remain in the 
laboratory 20 more minutes until repeat testing is completed and passed. 
 
Drug: Bulk CB (placebo, 3.6% THC/5.4% CBD) will be provided by the NIDA Drug Supply Program. Placebo 
CB is identical in appearance to active CB however THC and CBD have been extracted. Non-psychoactive 
plant material remains. Bulk CB will be stored in a freezer until the day before use. At least 12 hours before 
each session, CB will be thawed by staff and humidified in a closed humidifier with a saturated sodium chloride 
solution at room temperature (for security and storage aspects, see Security and Regulatory Aspects for 
Cannabis). These doses were selected based on previous chronic pain work suggesting that the pain-relieving 
effects of CB are experienced at lower THC doses. Previous work found that identical levels of analgesia were 
produced by both 7% and 3.5% THC concentrations26. Thus, THC in the 1-5% range was selected to avoid 
undesirable effects of CB administration (e.g., acute anxiety) that may occur in some subjects, particularly in 
individuals without recent exposure to CB. Previous research using similar samples suggests that such adverse 
effects are acceptable to patients with chronic pain4,27. 
 
Security and Regulatory Aspects for Cannabis: Cannabis is subject to regulatory control under Schedule I of 
the Controlled Substances Act and the Psychotropic Convention. Cannabis will be provided by the National 
Institute on Drug Abuse (NIDA) and will be stored frozen in an airtight container in a locked refrigerator safe 
located in a cement block room without windows and one door that is locked with code-protected card-key 
access at 121 South Main Street on the 3rd floor. Only DEA designated individuals will have access to this 
room (located in the same building and floor as the location of cannabis administration). Thus, cannabis will 
remain secure at all times. Cannabis will be prepared by a pre-designated staff member with DEA clearance. 
The staff member will retrieve cannabis prior to a scheduled experimental session, humidify it at room 
temperature for 24 hours before use (per NIDA’s instructions) in the same cement block room, and transfer it 
directly to the laboratory following the start of the session. Cannabis will be logged and monitored by the DEA; 
remainders will be incinerated as per compliance with the DEA regulations. Dr. Robert Swift, MD, PhD, 
Professor at CAAS, holds a Drug Enforcement Administration (DEA) license for Schedule I drugs with a 
specific approval for cannabis.  


8 
 
 
Statistical Analysis Plan: The sample size required for the proposed study is based on the primary outcome: 
pain assessment score. Using the results on SF-MPQ pain at present from Blake and colleagues to inform our 
parameters, we assume that participants will have a reduction in pain of 0.72 points following active cannabis 
compared to placebo cannabis with a standard deviation of the mean difference of 2.0715. We calculate the 
necessary sample size using a 2-period, 2-treatment, crossover design, comparing cannabis to placebo.  At a 
two-sided significance level of 0.05, a design encompassing 66 patients will have power equal to 0.79 to detect 
this difference with this standard deviation.  
 
The primary aim of this investigation is to assess current self-reported pain level (SF-MPQ) following cannabis 
administration (THC versus placebo). A one-sided t-test will be conducted to compare pain level following 
vaporization of each dose.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Nagata K, Yoshida M, Tokimura F, Kawaguchi H, Nakamura K. Reference values for hand grip strength, 
muscle mass, walking time, and one-leg standing time as indices for locomotive syndrome and associated 
disability: the second survey of the ROAD study. J Orthop Sci Off J Jpn Orthop Assoc. 2011 
Nov;16(6):768–777. PMID: 21975521 
21.  Middleton A, Fulk GD, Beets MW, Herter TM, Fritz SL. Self-Selected Walking Speed is Predictive of 
Daily Ambulatory Activity in Older Adults. J Aging Phys Act. 2016 Apr;24(2):214–222. PMCID: 
PMC4792803 
22.  Foltin RW, Fischman MW, Pedroso JJ, Pearlson GD. Marijuana and cocaine interactions in humans: 
cardiovascular consequences. Pharmacol Biochem Behav. 1987 Dec;28(4):459–464. PMID: 2829241 
23.  Ramaekers JG, Kauert G, van Ruitenbeek P, Theunissen EL, Schneider E, Moeller MR. High-potency 
marijuana impairs executive function and inhibitory motor control. Neuropsychopharmacol Off Publ Am 
Coll Neuropsychopharmacol. 2006 Oct;31(10):2296–2303. PMID: 16572123 
24.  Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 
2003;42(4):327–360. PMID: 12648025 
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complex cognitive performance. Neuropsychopharmacol Off Publ Am Coll Neuropsychopharmacol. 2001 
Nov;25(5):757–765. PMID: 11682259 
26.  Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-
controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain Off J Am Pain Soc. 2008 
Jun;9(6):506–521. PMCID: PMC4968043 
27.  Schnelle M, Grotenhermen F, Reif M, Gorter RW. [Results of a standardized survey on the medical use of 
cannabis products in the German-speaking area]. Forsch Komplementarmed. 1999 Oct;6 Suppl 3:28–36. 
PMID: 10575286 
  

ICF_001.pdf: 
 
 
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                       STANDARD CONSENT TEMPLATE |02/26/2020 
 
 
Cover page 
Official Title of Study: Impact of Cannabis on Pain and Inflammation Among 
Patients with Rheumatoid or Psoriatic Arthritis 
ClinicalTrials.gov Identifier: NCT04269993 
Document Type: Informed Consent form dated 11/16/2021 
Subtitle: N/A 
(The informed consent form document(s) uploaded in Portable Document 
Format Archival (PDF/A) format. It is strongly encouraged that the PDF/A file 
also be consistent with the PDF Universal Accessibility (PDF/UA) format, to 
optimize accessibility). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
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                       STANDARD CONSENT TEMPLATE |02/26/2020 
 
 
BROWN UNIVERSITY 
CONSENT FOR RESEARCH PARTICIPATION 
 
Impact of Acute Cannabis Administration on Pain Symptomology and Inflammatory Markers 
among Patients with Rheumatoid or Psoriatic Arthritis 
Project CANMID 
Version 3, 11/16/2021 
 
KEY INFORMATION: 
 
You are invited to take part in a Brown University research study. Your participation is 
voluntary. 
 
• PURPOSE:  The study is about determining whether cannabis can reduce pain and 
inflammation associated with inflammatory rheumatic diseases, such as rheumatoid 
and psoriatic arthritis. 
• PROCEDURES:  For all study sessions, you will be asked to avoid drinking alcohol for 
24 hours before sessions, and for the experimental sessions to also avoid caffeine and 
eating for 2 hours before your sessions. You may not use any marijuana outside the 
study sessions for the duration of your participation. You will be asked to breathe into a 
tube to test for alcohol and carbon monoxide in your lungs. You will also be asked to 
provide a urine sample, which will be tested for recent drug use, and if you are able to 
become pregnant, the urine will also be tested for pregnancy. You will be asked to use a 
highly effective birth control method during study participation. You will be asked to 
complete questionnaires and interviews about your medical history, complete computer 
tasks, have your height and weight measured, and complete a physical exam with our 
study physician or nurse practitioner. You will have blood drawn and vaporize 
marijuana as well. 
• TIME INVOLVED:  The first study session will take 3-4 hours (baseline session) and the 
other 2 sessions will be 5-6 hours each (experimental sessions) for a total up to 16 hours 
of participation. The experimental sessions will occur at least two days apart from each 
other to ensure that no cannabis remains in your system from the previous 
experimental session. 
• COMPENSATION:  You will receive compensation for participating in the study. You 
will receive $300 (if completing all 3 sessions). If eligible, you will receive $50 after 
completing the baseline session (including physical exam). You will receive $10 cash if 
found ineligible. After completing each of the experimental sessions, you will receive 
$100. Lastly, you will receive a $50 bonus after completing the second experimental 
session. 


 
 
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                       STANDARD CONSENT TEMPLATE |02/26/2020 
 
• RISKS:  You may feel uncomfortable responding to questionnaires or tasks, experience 
discomfort or pain from blood draws, impaired judgment or motor coordination, 
inhalation of particulate matter during vaporization, and other potential adverse 
reactions to marijuana. 
• BENEFITS:  We cannot and do not guarantee or promise that you will receive any 
benefits from this study. You will have a chance to contribute to a scientific study that 
may help people in the future. 
• ALTERNATIVES TO PARTICIPATION:  This is a research study and your participation 
is completely voluntary. 
1. Researcher(s):  
Elizabeth Aston, Ph.D., Center for Alcohol and Addiction Studies, Brown University School of 
Public Health, Box G-S121-5, Providence, RI 02903.  Co-investigator: Dr. Anthony M. Reginato, 
M.D., Brown Medicine Division of Rheumatology, Brown Physicians Patient Center. 
2. What is this study about? 
You are being asked to take part in a Brown University research study. The researcher will 
explain the purpose of the project. He or she will explain how the project will be carried out 
and what you will be expected to do. The researcher will also explain the possible risks and 
possible benefits of being in the project. Please read the form and ask the researcher any 
questions you have about any of these things before you decide whether you wish to take part 
in the study. This process is called informed consent.  
 
We are interested in learning whether vaporizing marijuana may reduce pain and 
inflammation among individuals with rheumatic diseases. This project is sponsored by the 
National Institutes of Health. 
 
Biospecimens (i.e., blood) collected from you for this research may be used to develop new 
tests or devices. Researchers, their organizations, and other entities, including companies, may 
potentially profit from the use of the data, biospecimens or discoveries from this research. You 
will not have rights to these discoveries or benefit financially from them. 
 
You are being asked to be in this study because you reported that you:  are between the ages of 
18 and 65 and are diagnosed with active rheumatoid or psoriatic arthritis. 
3. What will I be asked to do? 
Participants who complete the online or telephone pre-screening survey (and appear eligible 
to proceed to the baseline screening and physical exam) will be asked to meet with research 
staff for a brief, approximately 15-minute Zoom videocall to complete the informed consent 
and HIPAA Authorization form.  We will then schedule your baseline study session. 
 


 
 
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                       STANDARD CONSENT TEMPLATE |02/26/2020 
 
For all study sessions, you will be asked to avoid drinking alcohol for 24 hours and stop eating 
or consuming any caffeinated beverages 2 hours before your scheduled appointment on all 
experimental study days. You may not use any marijuana outside the study sessions for the 
duration of your participation.  During all study sessions, we will ask you to put your 
cellphone/personal technology device away at certain points to maintain confidentiality and 
so that the study tasks are not interrupted. 
 
For all study sessions: (a) you will be asked to breathe into a tube that will measure the 
amount of carbon monoxide in your lungs and this information will be used to confirm that 
you have avoided all smoking prior to today’s session. If the test suggests you have smoked 
within the past 15 hours, you will not be able to complete the session and will be given one 
more opportunity to come in for a session without smoking; (b) you will be asked to blow into 
a machine that will tell us whether you drank any alcohol before coming in. If there is alcohol 
in your breath, we will have to re-schedule the session; and (c) you will also be asked to give a 
urine sample, which will be tested for recent drug use. If you are able to become pregnant, the 
urine will also be tested for pregnancy. If you are pregnant, you will not be able to participate. 
You will be asked to use a highly effective birth control method during study participation. In 
the event of a positive urine test for illicit drugs, you may reschedule the session once.  
 
If you are found to be ineligible for the study based on the interview, repeated positive urine 
drug test, or found to be pregnant, you will be paid $10 for your time and effort.  
 
You will be asked questions about your substance use and medical and psychiatric history. 
Some of the questions may be of an embarrassing or sensitive nature and may make you 
uncomfortable. Therefore, you are free not to answer any questions you do not wish to answer. 
 
In order to establish full eligibility and proceed to the baseline session, participants must have 
a current diagnosis of active rheumatoid arthritis or psoriatic arthritis, as confirmed to us by 
your healthcare provider or via your medical record in your possession. If you were not 
directly referred to us by your doctor, we will ask you for your permission so that we can 
request your physician release this information to us. They would confirm your 
rheumatoid/psoriatic arthritis diagnosis with us.  They may also share bloodwork results or 
medical test results relevant to your arthritis, if applicable. You may also be able to share this 
information with us directly via your personal medical record in your possession. All 
information we obtain in the study is kept confidential, and all study data will not be stored 
with your name. 
 
Baseline (1st study visit) 
In order to confirm your eligibility for the study, you will be asked to complete several brief 
questionnaires and interviews about your medical, psychiatric, and substance use history. You 
will complete some tasks on a computer. You will also do some paper and pencil tasks. We 
will measure your height and weight.  


 
 
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                       STANDARD CONSENT TEMPLATE |02/26/2020 
 
  
If you still appear eligible after the interview, you will complete a physical exam with our 
study physician or nurse practitioner (hereafter referred to as the “study physician”). You will 
have blood samples drawn (~ 4 - 5 tablespoons total) during this session. An 
electrocardiogram (EKG) will be conducted. An EKG is a non-invasive method of measuring 
the electrical activity of your heart. We will attach ten electrodes to your chest and limbs using 
adhesive pads. We may need to shave a portion of hair from your chest and/or limbs in order 
to achieve sufficient adhesive and reading. There are minimal risks associated with the use of 
the EKG. There is a small possibility that you may experience some tenderness or reddening of 
the skin where the electrodes are placed. You may also feel slight irritation from the gel 
solution. These symptoms commonly dissipate soon afterwards. 
 
We may learn things about your health that require medical attention as part of the research 
physical exam. If this happens, this information will be provided to you at the time of the 
physical exam. You may need to meet with a medical professional with expertise to help you 
learn more about your research results and/or provide necessary treatment. The study 
team/study will not cover the costs of any follow-up consultations or actions.  
 
Following the physical exam, you will be asked to complete two experimental study sessions. 
Each experimental session should be completed at least two days apart from the previous 
experimental session. In order for this project to have scientific value, we will make every 
effort to contact you with reminders and confirmations of the scheduled experimental 
sessions.  Study staff will contact you via telephone and email for appointment reminders and 
information; you may also opt in to receive text message appointment reminders if you would 
like. 
 
Experimental Sessions (2 study visits) 
At each experimental session, you will inhale vaporized marijuana. Each session, you will 
vaporize marijuana of a different strength (“Dose A” and “Dose B”) using a specialized device. 
These two doses vary in their concentrations of delta-9-THC in the low to moderate potency 
range from session to session. The marijuana will be provided by the National Institute of 
Drug Abuse. We will have your blood pressure and heart rate monitored before, during, and 
after vaporization. You will have 3 blood samples drawn (~ 5 - 6 tablespoons total at each 
session) at each session, before and after vaporization, for analysis of cannabinoid and 
hormone levels. A trained phlebotomist, nurse, nurse practitioner, or physician will draw the 
blood samples from a vein/s in your arm each time.   
 
You will be asked to complete behavioral tasks and fill out some brief questionnaires every 
few minutes. Next, you will complete some of the same computer-based tasks and paper-and-
pencil questionnaires that you had previously completed. We will test your blood pressure 
and heart rate a few times during these sessions. You will remain in the laboratory for at least 
3 hours after vaporizing marijuana. You will also be evaluated for signs of impairment and 


 
 
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                       STANDARD CONSENT TEMPLATE |02/26/2020 
 
will complete a field sobriety test. Following evaluation of vital signs and successful 
completion of the sobriety test, you will be permitted to leave. You may not drive yourself or 
operate any other form of transportation (e.g., a bike, scooter, skateboard, etc.) but you may 
use other forms of transportation to get home (e.g., designated driver, taxi, rideshare, bus, 
etc.). You will be reimbursed for any transportation that requires payment home after the 
session. Assistance with transport to the laboratory for experimental sessions may be provided 
as needed. 
 
Certain information such as medications will be re-confirmed the morning of experimental 
sessions to maintain study eligibility. 
 
Your participation in this study may last up to 16 hours.  
4. Will I be paid?  
The first session will last 3 - 4 hours including time needed for the physical exam. You will be 
paid $50 for the first session (including the physical exam). The two experimental sessions will 
last 5 - 6 hours each. You will be paid $100 for each session. If you complete all study sessions, 
you will receive a $50 bonus at the second experimental session. The total possible payment 
you may receive for participating in this study will be $300. 
 
You are free to stop the study at any point during the session. If you choose to stop 
participating before the experimental sessions are complete, you will receive a prorated 
payment of $10 for the session in which you terminated early. 
5. What are the risks?  
There are some possible risks to participating in this study. Some of the questions may be of an 
embarrassing or sensitive nature and may make you uncomfortable. Therefore, you are free 
not to answer any questions you do not wish to answer. Some of the tasks you complete may 
be challenging and may cause stress or frustration. You will be asked to vaporize marijuana. 
There is a very low risk of inhaling some particulate matter. If this occurs, the vaporizer will be 
reset. The cannabis being administered is a natural plant product such that it may contain 
some mold, yeast, or bacteria from the environment. The marijuana that will be vaporized 
could contain low levels of potential organisms that could result in a serious lung infection for 
vulnerable patients. Chronic heavy use of cannabis can result in the development of a cannabis 
use disorder. However, this study involves a one-time administration of a single cannabis 
dose. Having blood drawn may cause redness, swelling, and bruising or brief bleeding. Other 
risks from standard blood draw procedures may include pain or discomfort, and fainting. 
Your judgment and motor coordination may be impaired, which is why you will need to stay 
with us for 3 hours after marijuana vaporization  
  
Other possible adverse reactions to marijuana include (1) injury due to slips, falls, or physical 
constraint in response to aggressive behavior; (2) fetal damage; (3) adverse interactions 


 
 
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                       STANDARD CONSENT TEMPLATE |02/26/2020 
 
between marijuana and medications for which marijuana use are contraindicated (e.g., 
psychotropic drugs, antihistamines); (4) exacerbation of medical problems for which marijuana 
use is contraindicated; (5) aggravation of pre-existing marijuana problems; (6) breach of 
confidence and embarrassment due to uninhibited behavior after vaporizing marijuana.  
  
Due to potential adverse effects of marijuana on a fetus, it is important for female participants 
to use a reliable means of contraception if engaging in sexual intercourse with a man during 
the course of this study. If you are capable of becoming pregnant and want to participate in 
this study, you must agree to complete a pregnancy test that we will provide and to use a 
medically accepted means of birth control. Let us know if you change your mind and decide to 
become pregnant during the study. You are not eligible to participate in the study if nursing 
your child, due to the medical risks and/or harms it causes to your child during development. 
  
While participating in the study, you cannot be using medications for which marijuana is 
contraindicated. You are asked to report all prescription and over-the-counter medications 
during your participation to guard against interaction with the marijuana that is administered 
in the study. You cannot have any medical conditions for which you should not use marijuana 
(e.g., heart conditions, neurological disorders). You are required to report these conditions on 
the medical history form to ensure your safety in the study. We will monitor your heart rate, 
blood pressure, and your reactions to marijuana at all times during the experimental sessions. 
If you experience an unpleasant reaction to marijuana, a licensed psychologist or the study 
physician will talk to you about your reaction. If you have moderately serious or serious 
unpleasant physical reactions to marijuana, the study physician will evaluate your need for 
emergency medical services. This study follows best practices for blood draw procedures. 
Sterile instruments, disinfecting agents, and non-latex materials will be used.  
  
You are free to stop vaporizing marijuana at any point during the study session. If you choose 
not to finish the marijuana vaporization, you will not be able to continue in the study, but you 
will receive compensation for the sessions you did complete and a prorated payment of $10 for 
the session in which you terminated early. 
6. What are the benefits? 
We cannot and do not guarantee or promise that you will receive any benefits from this study. 
You will have a chance to contribute to a scientific study that may help people in the future. 
7. How will my information be protected? 
Participation in this study and information gathered from the study will be kept confidential. 
All information obtained from you will be identified only by a code number. A record of your 
name (with address and telephone number) and your code number will be kept in a separate 
locked location, available only to the Brown University investigators and employees on this 
project. Your answers are confidential. To further protect your confidentiality, we will refer to 
ourselves during all telephone calls as “Brown University” and will not use any other 


 
 
8 
                       STANDARD CONSENT TEMPLATE |02/26/2020 
 
identifying information. The findings of the study may be published but individual 
participants will not be identified. We may use or share your research information [including 
blood samples] for future research studies but it will be de-identified, which means that it will 
not contain your name or other information that can directly identify you. Future research may 
be similar to this study or completely different. We will not ask for your additional informed 
consent for these studies. We may also share your de-identified information and blood 
samples with other researchers here, and at other institutions in the United States or around 
the world.  
 
Any reports related to child abuse/neglect or elder abuse will be reported by us to the 
appropriate authorities. A description of this clinical trial will be available on 
https://www.clinicaltrials.gov, as required by U.S. Law. This website will not include 
information that can identify you. At most, the website will include a summary of the results. 
You can search this website at any time. Because this research involves a substance regulated 
by the Food and Drug Administration (FDA), the FDA may choose to inspect and copy 
medical or research records that identify individual research subjects.   
  
We have obtained a Certificate of Confidentiality from the National Institutes of Health, which 
authorizes us to protect the identity of our research participants from any civil, criminal, 
administrative, legislative, or other proceedings, whether federal or state and local. We cannot 
be compelled to reveal the identity of our participants unless 1) you provide us with written 
authorization to disclose your identity, or 2) such release is required by the Federal Food, 
Drug, and Cosmetic Act, or 3) the National Institutes of Health requests such information for 
audit or program evaluation purposes. The certificate does not govern the voluntary 
disclosure of such information, nor does it represent an endorsement of the research project by 
the Department of Health and Human Services. Please be aware, however, that the certificate 
of confidentiality does not protect your identity in the event of your own disclosure of 
participation in this study. Therefore, it is important that you use your discretion with respect 
to participation in this study. 
 
Future Contact 
We would like to keep your contact information so that we can invite you to participate in 
other studies. If you agree, we would store your information in a separate, secure file. You 
would not be enrolled in any studies but may be asked to answer questions to decide if you 
are interested and eligible for future research projects. 
 
Brown University staff sometimes review studies like this one to make sure they are being 
done safely and correctly. If a review of this study takes place, your records may be examined. 
The reviewers will protect your confidentiality. 
8. Are there any alternatives to this study? 


 
 
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                       STANDARD CONSENT TEMPLATE |02/26/2020 
 
This is a research study and your participation is completely voluntary. Your alternatives 
include not participating in this research study. The decision whether to be in this study is 
entirely up to you. Participation is voluntary. Also, if you decide now to participate, you will 
be able to change your mind later and withdraw from the project. There will be no penalty if 
you decide not to be in the project or withdraw from the project later.  
 
9. What if I want to stop? 
You do not have to be in this study if you do not want to be. Even if you decide to be in this 
study, you can change your mind and stop at any time. 
 
If you refuse to participate in or leave the study, your current or future relationship with 
Brown University or Lifespan, if applicable, or will not be affected. 
10. Who can I talk to if I have questions about this study? 
If you have any questions about your participation in this study, you can call the Principal 
Investigator, Dr. Elizabeth Aston, at (401) 863-6668 or study staff at 401-863-6433. 
Alternatively, you may email Project-CANMID@brown.edu.  
 
Questions about the study should be directed to Dr. Elizabeth Aston at (401) 863-6668. 
11. Who can I talk to if I have questions about my rights as a participant? 
If you have questions about your rights as a research participant, you can contact Brown 
University’s Human Research Protection Program at 401-863-3050 or email them at 
IRB@Brown.edu. 
12. Consent to Participate 
(Check Yes or No, and sign your initials)  
  
I agree to be re-contacted for future studies:  
 
Yes/No  
_____ (initials)  
  
I agree to have my de-identified blood samples stored for testing for future studies:  
  
  
  
  
  
  
  
  
  
 Yes/No  
_____ (initials) 
 
Your signature below shows that you have read and understood the information in this 
document, and that you agree to volunteer as a research participant for this study.  
 
You will be offered a copy of this form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
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                       STANDARD CONSENT TEMPLATE |02/26/2020 
 
Participant's Signature and Date  
/  
 
 
PRINTED NAME  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research Staff Signature and Date 
 
/ 
 
  
PRINTED NAME