1. RESEARCH PROBLEMRESEARCH PROBLEM
RESEARCH QUESTIONRESEARCH QUESTION
IMPLICATIONSIMPLICATIONS
SAMPLESAMPLE
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KEY FINDINGS IN RESEARCHKEY FINDINGS IN RESEARCH
MEASURESMEASURES
FUTURE DIRECTIONFUTURE DIRECTION
Cannabidiol Therapy in the Treatment of Chronic Pain
Cory Ellen Gatrall, Andrea DiNardo, Allison Piela, Carly Raskin,
Katelyn Perchak, Hallie Baker, Regan Clover
Many patients with chronic pain do not obtain relief from current pain
management practices.
What is the effect of adding cannabis to current pain therapy on self-reported
pain in adult patients with chronic pain?
• Delta9- tetrahydrocannabinol (THC) is associated with a higher incidence of
adverse effects than cannabidiol (CBD), which has been shown to temper the
psychoactive effects of THC. (Aggarwal, 2013; Jognson et al., 2010; Jognson et
al., 2013; Martin –Sanchez et al., 2009; Motcutt et al., 2004; Russo & Guy, 2006;
Sagar et al., 2012; Ward et al, 2013).
• Patients do not develop pain medication tolerance when using cannabinoids and
upward titration is not required (Nurmikko et al., 2007; Pacher & Kunos, 2013;
Johnson et al., 2013).
• Average dosage of cannabinoid pain medications in previous studies ranged from
5.5 - 10.2 sprays per day (Johnson et. al., 2013; Johnson et. al., 2010; Nurmikko
et. al., 2007).
• THC:CBD medication (Naboximols), a common cannabinoid-based pain
medication, contains a fixed ratio of 2.7 mg THC and 2.5 mg CBD in 100 uL
spray (Portenoy et. al., 2012).
HYPOTHESISHYPOTHESIS
Patients who receive cannabidiol therapy will report less pain than patients who
do not receive cannabidiol therapy.
STUDY DESIGNSTUDY DESIGN
The sample will consist of 800 patients, age 18 – 65, who have reported pain for
at least 6 months.
Randomized, Double Blind, Pre-Post Qualitative Study
PROCEDUREPROCEDURE
LIMITATIONSLIMITATIONS
VARIABLESVARIABLES
Independent Variable: 1) THC/CBD, 2) CBD 3) Placebo
Dependent Variable: Self-reported Pain
Covariates: Nausea, Sleep, Appetite/Weight, Dizziness, Dys/Euphoria,
Anxiety, Treatment Compliance, Gender, Age, Race, Medications, Alcohol
and Drug Use
IV: Group 1: Naboximols oromucosal spray: 2.7 mg of THC And 2.5 mg
CBD in 100 uL carrier (Portenoy et al., 2012).
Group 2: CBD oromucosal spray: 2.5 mg of cannabidiol
Group 3: Placebo oromucosal spray
DV: Pain will be measured with the NRS Pain Scale. The pain scale uses a 0-
10 numerical scale; with 0 representing “no pain” and 10 representing “pain
as bad as you can imagine” (Ferreira- Valente et al., 2011). It had been tested
for reliability, with a high test- retest reliability found in a study of literate
(r=0.96) and illiterate (r=0.95) rheumatoid arthritis patients (Ferraz et al.,
1990). It had also been tested for construct validity in the same population,
demonstrating correlations between 0.85- 0.96 with another standard measure
of pain, the VAS Pain Scale (Ferraz et al., 1990).
Opioid Use: To measure opioid use, a hair sample with be obtained from
each subject.
Recruitment of subjects: Participants will be recruited using posters in eight
major pain clinics and hospitals within the U.S. Interested individuals will be
invited to a screening appointment, where they will have the opportunity to
discuss the study with a researcher and have all of their questions answered.
Once they are fully informed, written consent to participate will be obtained
Implementation of IV: Participants will be randomly assigned to one of three
groups: Each group will be assigned to use Naboximols (THC:CBD
combination medication), a CBD medication, or a placebo. Dose titration will
occur on an individual basis, as needed, to achieve therapeutic pain relief. The
medication dispenser will “lock out” after daily maximum has been dispensed,
which will be determined based upon the results of titration. Participants will
be instructed to record each usage of the spray, reporting their maximum daily
usage to investigators weekly. Patients will provide weekly urine samples so
that researchers can assess medication load.
Assessment of DV: Patients will self-report their pain levels using the NRS
Pain Scale, weekly
ANTICIPATED FINDINGSANTICIPATED FINDINGS
Patients in the experimental groups will report lower pain levels than the
patients in the placebo group
• Study will not be conducted in a controlled environment, thus researchers
will rely upon participant self- report.
• Variable legal status and social stigma of medical cannabinoid products
possession and use may limit recruitment and generalizability.
• The use of a single pain scale may limit the data’s validity. The NRS pain
scale, although a reliable tool, does not provide enough flexibility in the
pain assessment as it is a single tool and therefore a more narrow construct
of pain assessment.
• The potential findings may increase knowledge of cannabidiol products and
administration practices amongst nurses and professionals in the medical
field. The findings will also increase their knowledge about the effects of
patients’ usage of cannabidiol products.
• The results might influence the public’s perception of cannabidiol products
for medicinal purposes and hence influence public health policy. If the
public is in favor of using cannabidnoid products for medicinal purposes,
they can advocate to their legislators to help legalize such products in the
pharmaceutical arena.
• Closer investigation of the potential confounding variables and
dosage/titration effects may need to be further explored.
We plan to focus on establishing an effective dosage and titration in subsequent
phases of the trial. For example, if we find a specific dosage demonstrates
beneficial effects, we would conduct another study focusing on pain relief for
that dosage amount. We would also share results with public health professionals
and policymakers.
ANTICIPATED PROBLEMSANTICIPATED PROBLEMS
Patient adherence could be a problem. Patients may take more or less
medication to achieve their desired effect (Pacher & Kunos, 2013). In
order to address this, we will perform weekly urine screens to monitor
medication load. Other anticipated problems include medication
sharing, recruitment of adequate size, and titration.