This document summarizes a proposed study on the effects of medical marijuana on reducing symptoms of post-traumatic stress disorder (PTSD). The study would utilize a randomized, double-blind experimental design with 200 participants divided into a control group receiving placebo and an experimental group receiving medical marijuana capsules. Participants would be evaluated quarterly for one year using standardized PTSD assessment tools. The goal is to determine if medical marijuana can effectively reduce PTSD symptoms compared to a placebo by analyzing differences in assessment scores between the two groups over time. Limitations include not addressing effectiveness for long-term PTSD or those taking other medications. If significant results are found, it could provide evidence for medical marijuana as an approved PTSD treatment.

1. MEDICAL MARIJUANA USE & REDUCTION OF POST-TRAUMATIC
STRESS DISORDER SYMPTOMS
Team :
Jennifer Youngs & Wilson Ospina
Faculty Mentor: Dr. Halcyon St. Hill, Professor
IHS 4504 Research Methods CRN: 80374
Florida Gulf Coast University
Date: November 10, 2014
1

2. ABSTRACT
The causes, symptoms, treatments, and effects of Post-traumatic Stress Disorder can be
extremely costly. It has a high prevalence rate and is a major health concern. Medical
marijuana has valuable health benefits, and is already being utilized legally in many states, as
well as illegally by suffering patients, who get it from the black market. All evidence supports
and elicits the need for further research to determine whether Medical marijuana should be
utilized as a legal form of treatment for patients suffering from PTSD, and other chronic
conditions. Though it is demonstrated that medical marijuana is effective at reducing
symptoms of PTSD, more studies need to be performed in order to add validity and empirical
evidence to support these claims.
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3. INTRODUCTION: LITERATURE REVIEW
 After many years of categorization as a Schedule 1 narcotic by the Drug
Enforcement Administration (DEA) of the United States, within the last two
decades, much attention has been placed on the therapeutic benefits of medical
marijuana (Title 21 United States Code (USC) Controlled Substances Act, n.d.)
 As of 2014, twenty-three states have amended State laws allowing use of
medical marijuana for treatment of Post Traumatic Stress Disorder (PTSD),
along with several other debilitating medical conditions (State Marijuana Laws
Map, n.d.)
 FDA approved two pharmacological agents to treat PTSD, include the (Setraline
or Paroxetine);
 Both drugs are known as selective serotonin reuptake inhibitors (SSRIs) and
only have a 50 % success rate at reducing symptoms (Cukor, Olden, Lee, &
Difede, 2010).
3

4. INTRODUCTION: LITERATURE REVIEW
 Medical marijuana has been shown to have anti-epileptic properties , sedative
type effects, as well as anxyiolytic and anti-psychotic effects (Zuardi, 2008).
 Medical marijuana use has been shown to remove aversion memories, which are
the root causes of PTSD(Greer, Grob, & Halberstadt, 2014).
 Post-traumatic Stress Disorder occurs after an individual has suffered from a
traumatic or petrifying experience such as:
1)sexual assault 4)terrorist attacks 7)unnerving experiences
2)physical abuse and neglect 5)combat warfare
3)environmental disasters 6) traumatic accidents
(U.S. Department of Veterans Affairs, 2013).
4

5. INTRODUCTION: LITERATURE REVIEW
 Symptoms that are associated with PTSD vary but generally include:
1) anger and irritability 2) anxiety
3) fear and panic 4) feeling of hopelessness
5) depression and sadness 6) Feelings of blame, remorse and guilt
7) changes in demeanor 8) changes in conduct
9) loss of sense of self-identity
(U.S. Department of Veterans Affairs, 2013).
 Severity of PTSD is not only affected by the symptom type and cause, but
also by the duration of such symptoms (Freedy & Brock, 2010).
5

6. TOPIC, PROBLEM, AND PURPOSE
 Topic:
 Medical marijuana as a treatment for reducing symptoms in patients
diagnosed with Post-traumatic Stress Disorder.
 Problem:
 There is no known cure for PTSD, therefore, it is not known whether use of
marijuana will have positive effects on PTSD related symptoms.
 Although various states have currently legalized the use of medical
marijuana, federally it is still considered an illegal Schedule I narcotic in
accordance with the Controlled Substances Act (CSA) of 1970 (Title 21
United States Code (USC) Controlled Substances Act, n.d.)
 Purpose:
 To indicate that there is a positive correlation between using cannabinoids
and reducing symptoms of PTSD.
6

7. RESEARCH QUESTION
AND THEORETICAL POPULATION
 Question:
 What are the effects of Medical marijuana use on symptoms
associated with PTSD, for men and women age 18 to 55, who
have been diagnosed with PTSD within the past six months and
have not yet begun treatment?
 Hypothesis:
 Medical marijuana use will reduce symptoms associated with
PTSD.
7

8. METHODS: RESEARCH DESIGN
 This will be a true experimental study, and will include
 Two group, pretest-posttest randomized experiment
 Notational Form:
 R = Random assignment
 X = Treatment program
 O1 = Baseline Assessment scores
 O2= Treatment Impact Assessment scores
 O3=Treatment Impact Assessment scores
 O4= Treatment Impact Assessment scores
8
R O1 X O2 X2 03 X3 04
R O1 02 03 04

9. METHODS: STEPS
 Participants will be pre-screened to meet the inclusion-
exclusion criteria .
 Participants will be evaluated for current substance abuse using
a serum drug screening method.
 Double-blind, random assignment of patients into control, and
experimental groups to eliminate bias.
 Control group will receive a three month supply of 25mg
placebo treatment to be taken orally three times daily.
9

10. METHODS: STEPS
 Experimental group will receive a three month supply of 25mg
capsules of concentrated medical marijuana to be taken orally three
times daily.
 This study is designed to last for one year, with quarterly
evaluations/observations of symptoms.
 At each quarterly evaluations serum drug screens will be performed
to help control extraneous variables.
 The study will conclude with a final post-test evaluation.
10

11. METHODS: RATIONAL AND INTERNAL VALIDITY
 Rational for Design:
 We used Two group, pretest-posttest randomized double blind
experimental design because this is a true experiment and
needed a strong type of design to eliminate all threats to validity
and to further provide sufficient structure and accuracy of
results.
 Internal Validity:
 Will be fair because quarterly drug screening methods will be
used to help control some extraneous variables.
 Other extraneous factors may be more difficult to control
because this study will not be conducted in a laboratory.
11

12. SAMPLE:
THEORETICAL POPULATION & SAMPLING FRAME
 Theoretical Population:
 Males and females ages 18 to 55, diagnosed with Post
Traumatic Stress Disorder according to the guidelines of
Diagnostic and Statistical Manual of Mental Disorders, 5th
edition.
 Sampling Frame
 Subjects will be recruited by requesting local veteran’s
centers, physician offices, and mental health clinics to refer
interested suitable patients, and by advertising in local media
(t.v, radio, social internet media, and local newspapers).
12

13. SAMPLE: STUDY POPULATION
 Study Populations
 Males and females, between the ages of 18 to 55, diagnosed with
Post Traumatic Stress Disorder within the last six months,
according to the guidelines of Diagnostic and Statistical Manual of
Mental Disorders, 5th edition, in the following states:
 1) California 4) Oregon
 2)Colorado 5)New Jersey
 3)Illinois 6)New York
13

14. NATIONAL DISTRIBUTION OF STUDY
14

15. HUMAN RIGHTS ISSUES
 Institutional Review Board (IRB) approval will be obtained prior
to beginning the study.
 All Participants will be provided full disclosure about the study
including all requirements set by the IRB to ensure
confidentiality, and privacy.
 All participants will be given the opportunity to ask questions
prior to signing the required informed consent documents.
 All participants will be provided contact information, and will be
given the opportunity to withdraw at any time.
15

16. SAMPLING METHOD
 Purposive, non-probability sampling
 Sampling will be performed with the purpose of finding
only patients diagnosed with PTSD within the past six
months.
 This method was chosen because sampling for
proportionality is not a concern since it only applies to
those diagnosed with PTSD within the last six months who
have not yet begun treatment.
16

17. SAMPLE: INCLUSION CRITERIA
 Participants must have been diagnosed with PTSD according to the
guidelines of Diagnostic and Statistical Manual of Mental
Disorders, 5th edition, by a licensed physician.
 Males and females ages 18 to 55 who have been diagnosed with
PTSD within the past six months who have not yet begun treatment.
 Participants must be pre-screened to verify no marijuana or illegal
substance usage in the past 30 days.
 Must be willing to submit to a health screening prior to
commencement of study.
17

18. SAMPLE: EXCLUSION CRITERIA
 Participants that have any illnesses or other diseases that may
interfere with the study.
 Participants that take any prescribed or self prescribed
medications.
 Participants found to have failed the serum drug tests during the
quarterly evaluations.
 Participants that do not attend and complete follow-up
evaluations.
 Those that are unable to sign the informed consent document.
18

19. ANALYSIS OF SAMPLING
 The projected sample size is 200 individuals, composed of 100 male and
100 female participants who satisfy the inclusion and exclusion criterion.
 50 males and 50 females will be randomly assigned to the placebo control
group, while the other 50 males and 50 females will be assigned to the
experimental group.
 This study will be replicated in each state previously listed under the
population frame.
 The sample size will be of sufficient size for the study because:
 Variables include a placebo control group, experimental non-control
group, so there should be sufficient information from this sample size to
analyze these limited variables and it will be representative of the
population.
19

20. ANALYSIS OF SAMPLING
 The sample size includes proportional samples of men and women
from various states nationwide to ensure accuracy.
 Bias will be controlled with randomization, and by utilizing the
double blind method.
 External validity
 will be good because the samples will be representative of
different geographic locations throughout the nation, which will
allow finding to be generalized to populations beyond the
actual study group.
 bias will be eliminated by the design type.
20

21. GROUP ASSIGNMENT
 Random Group Assignment:
 200 participants will be recruited from each state in which the
study is being conducted; 100 males and 100 females.
 From the sample groups, 50 males and 50 females will be randomly
assigned to the placebo control group, while the remaining 50 males
and 50 females will be randomly assigned to the experimental control
group.
 Double blind:
 The participants will be blind as to which group they belong to (the
control, or the experimental).
 The researchers will not know which groups in which the participants
belong.
21

22. TREATMENT
 Treatment: Medical Marijuana Program
 Control group will receive a three month supply of 25 mg
placebo treatment to be taken orally three times daily for
one year.
 Experimental group will receive a three month supply of
25mg capsules of concentrated medical marijuana to be
taken orally three times daily.
22

23. DATA COLLECTION:
 Instruments:
 Clinician-Administered PTSD Scale (CAPS - 5)
 Post Traumatic Stress Disorder Symptoms Scale Interviews
(PSS-I). (See handouts for example)
 Serum drug tests
23

24. DATA COLLECTED: CAPS-5 SCORES
 The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-
item structured interview that can be used to:
 Make current (past month) diagnosis of PTSD
 Make lifetime diagnosis of PTSD
 Assess PTSD symptoms over the past week
 The CAPS was designed to be administered by clinicians and clinical
researchers who have a working knowledge of PTSD, but can also be
administered by appropriately trained paraprofessionals. The full interview
takes 45-60 minutes to administer (PTSD: National Center for PTSD, n.d.)
 Inter-rater Reliability is high
24

25. DATA COLLECTED: PSS-I SCORES
 The PTSD Symptom Scale PSS-I is a 17-item semi-structured interview
that assesses the presence and severity of DSM-IV PTSD symptoms
related to a single identified traumatic event in individuals with a known
trauma history.
 The PSS-I takes about 20 minutes to administer and can be administered
by lay interviewers trained to recognize the clinical picture in
traumatized persons. Each item is assessed with a brief, single question
(PTSD: National Center for PTSD, n.d.)
 Inter-rater Reliability is high
25

26. DATA COLLECTED: VALIDITY & RELIABILITY
 Participants all be given the same Questionnaires, given the same
instruction on how to fill it out, and will be encouraged to answer
honestly in order to ensure validity and reliability.
26
PSS-I CAPS-5

27. SCHEDULE
 This study is designed to last for one year, with quarterly
evaluations & observations of symptoms.
 At each quarterly evaluation, serum drug screens will be
performed on each participant to help control extraneous
variables. Additionally complete blood count and chemistry
panels will be performed to establish a baseline results. Blood
test results will be monitored throughout the duration of the
study to monitor the over all health of each patient.
 The study will conclude with a final post-test evaluation.
27

28. DATA ANALYSIS
 Since two mean scores will be compared , a t- test will be used.
 Control group will be receiving placebo treatment
 Experimental group will be receiving the medical marijuana treatment
 Both of these groups will be compared to establish if there is a difference
between the mean of the control group and the mean of the experimental
group.
 The results of this study will be presented using graphical and tabular form
to illustrate, independently, how each group changed.
28

29. PLAN / TIME SCHEDULE
29
 Participants will be evaluated and tested at quarterly intervals for one year.
During which, the CAPS-5 and the PSS-I questionnaires will be
administered.
 Blood tests will be performed at every interval beginning with Q1. which
include : Drug Screen Standard 9-Panel, Complete Blood Count Panel, and
a Comprehensive Metabolic Panel.

30. DISCUSSION: SIGNIFICANCE AND FEASABILITY
 Significance:
 This study is significant because it has the potential to identify
Medical marijuana as an effective treatment for PTSD related
symptoms.
 Feasibility:
 This study is feasible because:
 It is not difficult to implement
 Methodology listed is easy to replicate
 Study is cost effective.
 The benefits of the study outweigh the risks.
 Time length of the study is appropriate.
30

31. THREATS TO EXTERNAL VALIDITY
 Selection-treatment interaction
 Some characteristic of the participants selected for study could interact
with some aspect of the treatment.
 Can include prior experiences, personality factors, or any other traits
that could interact with the effect of the treatment.
 Experimenter Effects
 The possibility the an experimenter may influence the performance of
the participants in the study (Neutens, 2014).
31

32. LIMITATIONS
 Limitations:
 This study does not address the effectiveness of medical marijuana
on PTSD symptoms for individuals who have suffered from long
term PTSD.
 This study does not address the effectiveness of medical marijuana
on PTSD symptoms for minors with PTSD.
 This study does not address the effectiveness of medical marijuana
on PTSD symptoms for individuals who also take other prescribed
medication.
32

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