A Double-Blind, Placebo-Controlled Study of Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors
Phase: PHASE2
Conditions: Trichotillomania, Skin-Picking
Sponsor: University of Chicago

 
                                                                                                            
 
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A Double-Blind, Placebo-Controlled Study of Dronabinol in Trichotillomania and Other 
Body focused Repetitive Behaviors 
 
IRB: 18-0542 
Version: 06 June 2020 
 
 
Jon E. Grant, J.D., M.D., M.P.H. 
University of Chicago 
Chicago, IL 

 
                                                                                                            
 
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A Double-Blind, Placebo-Controlled Study of Dronabinol in Trichotillomania 
 
This clinical trial will be conducted in the spirit of Good Clinical Practice (GCP) and in 
accordance with this IRB approved protocol.  No deviation from the protocol will be 
implemented without the prior review and approval of the IRB except where it may be necessary 
to eliminate an immediate hazard to a research subject.  In such a case, the deviation will be 
reported to the IRB as soon as possible. 
 
Investigational Agent and Dosing 
 
 
Dronabinol 5mg to 15mg po qday 
 
Population 
 
 
The population to be studied for this trial is 50 men and women ages 18-65 who have a 
current DSM-5 diagnosis of trichotillomania or other body focused repetitive behavior (BFRB) 
(e.g., skin picking disorder). 
 
Project Goals 
 
 
The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in 
trichotillomania. 50 subjects with DSM-5 trichotillomania or other BFRB will receive 10 weeks 
of double-blind dronabinol or placebo. The hypothesis to be tested is that dronabinol will be 
effective and well tolerated in patients with trichotillomania or other BFRBs compared to 
placebo. The proposed study will provide needed data on the treatment of disabling disorders 
that currently lacks a clearly effective treatment. 
 
Background  
 
Pathological hair-pulling, trichotillomania, has been defined as repetitive, intentionally 
performed pulling that causes noticeable hair loss and results in clinically significant distress or 
functional impairment (1). Although discussed in the medical literature for over one hundred 
years, and affecting all strata of society, there have been no epidemiological studies detailing 
how common trichotillomania is and there are no clear treatment approaches for everyone with 
trichotillomania. Behavioral therapy is generally regarded as the first-line treatment but trained 
therapists are difficult to find. In addition, there is no medication currently approved by the Food 
and Drug Administration for trichotillomania.  Trichotillomania is related clinically to other 
BFRBs, specifically skin picking disorder. In fact, it appears that trichotillomania and skin 
picking disorder may in fact share a common neurobiology.  Other BFRBs such as skin ppicking 
disorder also lack any agreed upon medication intervention, but evidence suggests that both skin 
picking disorder and trichotillomania may respond to the same interventions. 
 
The Trichotillomania Impact Project survey showed that only 15% of adults in the 
community with trichotillomania reported experiencing significant improvement with treatment 
of their symptoms (2). This may be because of the ongoing difficulty of finding a therapist 

 
                                                                                                            
 
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experienced in trichotillomania treatments. More than 55% of persons in this survey believed 
that their clinician did not have sufficient knowledge of the disorder, and less than one-third were 
receiving evidence-based treatments for trichotillomania (2). 
A recent meta-analytic study of randomized treatment trials in adults demonstrated that 
behavioral treatments, mainly habit reversal therapy, have the greatest efficacy in treatment of 
trichotillomania and skin piking disorder (3).  Selective serotonin reuptake inhibitors (SSRIs) are 
the most widely used treatment for adults with trichotillomania and skin picking disorder, despite 
evidence that their efficacy is no greater than placebo (3).   
Instead of using SSRIs, we conducted an open-label study of dronabinol a synthetic form 
of tetrahydrocannabinol (THC) approved by the FDA as an appetite stimulant for people with 
AIDS and antiemetic for people receiving chemotherapy, in 14 women with trichotillomania and 
found that 9 (64.3%) responded to treatment and that the mean effective dose was 11.6 ± 4.1 
mg/day (4). 
Recent studies using diffusion tensor imaging demonstrated that both trichotillomania 
and skin picking subjects exhibited significantly reduced fractional anisotropy in anterior 
cingulate, pre-supplementary motor area, and temporal cortices (5). These data suggest that the 
disorganization of white matter tracts in motor habit generation and suppression may underlie the 
pathophysiology of these disorders (5). Neurochemically, motor habits may rely partially on the 
endocannabinoid system. CB1 receptors are highly expressed in the basal ganglia nuclei, the 
hippocampus, cerebellum, and neocortex (6-7) and are implicated in attenuating glutamatergic 
exocitotoxic damage by suppressing the neuronal release of glutamate via inhibition of calcium 
channels (8-10). The activation of CB1 receptors reduces glutamate release in the dorsal and 
ventral striatum [possibly through an interaction with brain-derived neurotrophic factor (11)], 
thereby modulating neurotransmission in the basal ganglia and mesolimbic reward system (12). 
Stress-induced anxious behavior has been associated with the loss of CB1 receptor function in 
the striatum (13). 
Glutamatergic dysfunction has been implicated in the pathophysiology of 
trichotillomania (14-15). Pharmacotherapies, such as dronabinol, that target excessive 
glutamatergic drive through its effects on CB1 Receptors may, therefore, be expected to correct 
the underlying pathophysiology and symptoms of trichotillomania.  
In the USA, dronabinol is FDA-approved for the treatment of anorexia associated with 
weight loss in patients with AIDS and nausea and vomiting associated with cancer 
chemotherapy. In our previous study examining dronabinol for trichotillomania, doses between 5 
and 15mg/day were well tolerated and beneficial (4). This lack of significant side effects is 
consistent with other studies of dronabinol where it has been associated primarily with central 
nervous system-related adverse events (for example, confusion, dizziness, euphoria, and 
somnolence), but these adverse events are generally mild to moderate in severity and generally 
reversible upon dose modification (16-17). 
Given the serious personal consequences associated with trichotillomania and skin 
picking disorder, and the likelihood of success of dronabinol in treating both disorders, the aim 
of the present study was to examine the efficacy and safety of dronabinol vs placebo in adults 
with trichotillomania or skin picking disorder using a double-blind, placebo-controlled design. 

 
                                                                                                            
 
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We hypothesize that dronabinol will be more effective than placebo in reducing the 
frequency of hair pulling and skin picking and in improving overall psychosocial functioning 
after 10 weeks of treatment when compared to baseline. 
 
Primary Aim/Objective 
 
The aim of the present study is to examine the efficacy and safety of dronabinol vs 
placebo in adults with trichotillomania and skin picking disorder. 
 
Co-Primary Endpoint(s):  
The co-primary efficacy measures will be the change in hair pulling or skin picking 
frequency and urges to pull hair or pick skin for the past week as indicated by change in total 
score on the NIMH Trichotillomania Symptom Severity Scale (for TTM) or Skin Picking 
Symptom Assessment Scale (for SPD),  reliable and valid clinician-administered measures (18-
19), as well as the same scale modified for skin picking disorder, and the change in psychosocial 
functioning over the same time period using the Sheehan Disability Scale (20). The co-primary 
efficacy end points will be the change in these measures from baseline to week 10. 
 
Secondary Aim/Objective 
 
A secondary aim of the study is to examine the effects of dronabinol vs placebo on self-
report measures of hair pulling, skin picking, quality of life, and measures of mood and anxiety. 
 
Secondary Endpoint(s):  
Secondary efficacy measures include the change in number of days per week pulling, the 
Clinical Global Impressions–Improvement Scale (CGI-I) rated global improvement of symptoms 
over time (results will be dichotomized as improved [CGI-I ratings of 1 or 2 very much/much 
improved] or not improved [CGI-I ratings of 3-7]) (20), the self-report Massachusetts General 
Hospital Hairpulling Scale (22), the Skin Picking Symptom Assessment Scale, the Quality of 
Life Inventory (23), the Hamilton Depression Rating Scale (24), the Hamilton Anxiety Rating 
Scale (25), and the Tridimensional Personality Questionnaire 
 
 
Methodology 
 
50 individuals with trichotillomania or skin picking disorder will be recruited for a 
double-blind, placebo-controlled pilot study in which dronabinol or placebo is administered in a 
1:1 fashion. All 50 subjects will have trichotillomania or skin picking disorder per DSM-5 
criteria. Following baseline measures, all subjects will be randomized to either dronabinol or 
placebo and seen every 2 weeks for the first four weeks and every 3 weeks for the remainder of 
the 10-week period.  
 
Participants will be started at 5mg po qday for 2 weeks, then 5mg po bid for 2 weeks and 
then 5mg TID for the remaining 6 weeks. Participants will only go up to the full dose if clinically 
needed. Efficacy and safety measures will be performed at each visit.   

 
                                                                                                            
 
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The study will be conducted in accordance with the International Conference on 
Harmonization Guideline for Good Clinical Practice, all local ethical and legal requirements, and 
the World Medical Assembly (Declaration of Helsinki). The study protocol and procedures will 
be approved by the University of Chicago’s institutional review board prior to any recruitment. 
Written informed consent will be required for study participation. 
 
 
Randomization of drug will be conducted in blocks of eight.  The blind will be assessable 
to the study subject at all times by calling the pharmacy number listed on the medication bottle.  
The investigational pharmacy will follow proper accountability procedures in regards to both 
randomization of the study drug and holding of the blind. 
  
Subjects:  
Inclusion criteria:  
1) men and women age 18-65;  
2) current DSM-5 trichotillomania or skin picking disorder; and  
3) Ability to understand and sign the consent form. 
. 
 
Exclusion criteria:  
1) Unstable medical illness based on history or clinically significant abnormalities on 
baseline physical examination  
2) Current pregnancy or lactation, or inadequate contraception in women of childbearing 
potential 
3) Subjects considered an immediate suicide risk based on the Columbia Suicide Severity 
rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)  
4) Past 12-month DSM-5 diagnosis of psychosis, major depressive disorder, bipolar 
disorder, mania, or a substance or alcohol use disorder 
5) Illegal substance use based on urine toxicology screening  
6) Stable dose of medications for at least the past 3 months 
7) Previous treatment with dronabinol 
8) Cognitive impairment that interferes with the capacity to understand and self-
administer medication or provide written informed consent  
 
Baseline Assessments:  
Those subjects who appear appropriate for the study, based on telephone screening, will 
be invited for a baseline assessment. The duration of the baseline assessment will be 
approximately 90 minutes and will include the following: informed consent, demographic data, 
concomitant medications (no psychotropic medications will be allowed), and family history data. 
There will also be a physical examination (including weight, and vital signs, urine pregnancy test 
for women of childbearing years and urine drug screen, as well as a baseline blood draw to 
assess nutritional status. The blood draw is optional to the subject and will administered at the 
PI’s discretion). Finally, the subjects will undergo  a psychiatric evaluation (using the MINI 
International Neuropsychiatric Interview). 
In addition, the following instruments will be completed at the screening visit: 1) NIMH 
Trichotillomania Symptom Severity Scale (or the same scale modified for skin picking); 2) 
Sheehan Disability Scale; 3) Massachusetts General Hospital Hairpulling Scale; 4) the 17-item 

 
                                                                                                            
 
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Hamilton Rating Scale for Depression (HAM-D); 5) the 17-item Hamilton Rating Scale for 
Anxiety (HAM-A); 6) Clinical Global Impression (Improvement and Severity) scale; 7) 
Cambridge Caffeine Use Questionnaire; 8) The Dietary Fat and Free Sugar Questionnaire and 9) 
the Quality of Life Inventory; 10) Cambridge-Chicago Trait Scale (12); the Skin Picking 
Symptom Assessment Scale (SP-SAS); and the Body Focused Repetitive Behavior Broad 
Assessment Measure (BFRB-BAM), a new scale being added for validation purposes. In 
addition, subjects will undergo cognitive assessments at baseline and study endpoint.  
Cognitive Assessments: Assessments of cognitive control will be comprised of several valid 
paradigms (See below). These tasks are designed to probe dissociable neural circuitry and 
cognitive processes likely to be implicated in the pathophysiology of addictions. Task order was 
chosen arbitrarily and will be applied consistently across subjects, to minimize possible 
confounding factors of differences in task order across participants. 
 
The following tasks will be administered at baseline and final visits: 
 
 
-Stop Signal Task of Inhibitory Control (SST) 
 
 
-Intra-dimensional/Extra-dimensional Set Shift Task (ID/ED task) 
 
 
-One Touch Stockings Task (OTS) 
 
 
-Rapid Visual Processing Task (RVP) 
 
 
-Spatial Working Memory Task (SWM) 
 
 
-Cambridge Gambling Task (CGT) 
 
Following-Up Visit Assessments 
All follow-up visits will include all psychiatric measures (except the MINI which will be 
done at baseline only) and safety measures (adverse events, vital signs, C-SSRS). There will be 
four follow up visits for a total of five visits. 
 
Subject Compensation 
Subjects will be compensated $20 per visit, for a total of $100. Compensation will be given in 
the form of a check at the end of the study, as per University of Chicago protocol. 
 
Safety Assessments 
Safety and tolerability will be assessed using spontaneously reported adverse events data, 
Columbia–Suicide Severity Rating Scale (C-SSRS), vital signs, and by evaluating premature 
termination. Safety assessments (C-SSRS, sitting blood pressure, heart rate, adverse effects, and 
concomitant medications) will be documented at each visit. Subjects who are an immediate 
suicide risk will be removed from the study and appropriate clinical intervention (e.g. 
hospitalization) will be arranged. Urine pregnancy tests will be performed at the initial visit. 
Subjects who have a positive urine pregnancy test will be excluded from the study. Assessment 
of side effects will be done at each visit. AEs will be coded by system organ class (SOC) and 
preferred term (PT) using the Medical Dictionary for Regulatory Activities (Med- DRA) 
Version11.1. The incidences of all AEs will be summarized descriptively. In terms of vital signs, 
those subjects with abnormal blood pressures will be assessed for symptoms of hypo- or 
hypertension. Asymptomatic subjects will be evaluated each visit for changes in vital signs. In 
the case of hypertensive emergencies (BP greater than 210/120), appropriate referral to the 
emergency room will be made. In the case of hypotension (BP less than 90/60), participants will 
be evaluated for symptoms of hypotension and if symptomatic, appropriate interventions will be 
made. 

 
                                                                                                            
 
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Seizure and seizure-like activity have been reported in patients receiving dronabinol.  
Therefore, history of seizures will be an exclusion criterion. If a seizure occurs, dronabinol will 
be discontinued.  Participants will be advised to discontinue dronabinol and contact a healthcare 
provider immediately if they experience a seizure. 
Although the seizure risk needs to be taken seriously, the occurrence of new seizures 
from dronabinol, when excluding patients with a seizure disorder, appears to be fairly low even 
in medically compromised patient (25). In the proposed study, our dose of dronabinol is only up 
to a total of 15mg each day and patients with trichotillomania are on average quite healthy. This 
may explain why we saw only a small amount of mild side effects in our previous study (4). 
Table 1 outlines adverse events that occurred in subjects with AIDS –related anorexia 
and chemotherapy-related nausea as well as not medically compromised subjects with 
trichotillomania (4). 
 
Table 1 
Adverse events associated with dronabinol 
  
Pooled trial data 
from studies of 
subjects with 
AIDS-related 
anorexia and 
chemotherapy-
related nauseaa 
Trichotillomania study participants (n = 14) 
Adverse event 
Dose range (5–
20 mg/day) 
2.5 mg/day 
(n = 14) 
5 mg/day 
(n = 13) 
10 mg/day 
(n = 12) 
15 mg/day 
(n = 7) 
Light-
headed/dizzy 
3–10% 
2 (14.3%) 
1 (7.7%) 
1 (8.3%) 
– 
“High” (i.e., easy 
laughing, elation, 
and heightened 
awareness) 
8–24% 
– 
1 (7.7%) 
2 (16.7%) 
– 
Sedation 
3–10% 
1 (7.7%) 
1 (7.7%) 
– 
– 
Dry mouth 
Frequency not 
specified 
– 
1 (7.7%) 
1 (7.7%) 
– 
Constipation 
Frequency not 
specified 
– 
1 (7.7%) 
– 
– 
Headache 
<1% 
– 
– 
1 (7.7%) 
– 
Nausea/vomiting 
3–10% 
– 
1 (7.7%) 
– 
– 
Abdominal pain 
3–10% 
– 
– 
– 
– 
Paranoia 
3–10% 
– 
– 
– 
– 

 
                                                                                                            
 
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Pooled trial data 
from studies of 
subjects with 
AIDS-related 
anorexia and 
chemotherapy-
related nauseaa 
Trichotillomania study participants (n = 14) 
Any side effect 
Frequency not 
specified 
3 (21.4%) 
6 
(46.2%) 
5 (41.7%) 
0 
a http://www.fda.gov/ohrms/dockets/dockets/05n0479/05N-0479-emc0004-04.pdf 
and http://www.merckmanuals.com/professional/lexicomp/dronabinol.html 
 
 
Subject Withdrawal 
If a subject withdraws from the study, all instruments administered at the screening visit 
will be completed at the final visit.  These will be conducted when the subject is able to come in 
for an early termination visit.  Withdrawn subjects will be given the phone number of the 
principal investigator as well as the phone numbers of local resources for trichotillomania and 
skin picking.   
 
Data and Safety Monitoring Plan 
1. Responsibility for Data and Safety Monitoring 
The PI will have overall responsibility for monitoring the integrity of study data and 
participant safety.  
2. Procedures for Monitoring Participant Safety 
The PI will implement the following procedures to ensure data integrity and the safety of 
participants during the study. 
 A number of elements of the research plan are intended to minimize the risks of 
study participation. If subjects become actively suicidal with intent and plan to 
kill themselves, the PI will evaluate them and refer them for immediate non-study 
treatment. Any participant endorsing suicidal thoughts with intent and plan will be 
immediately evaluated by the PI and referred to a higher level of care if clinically 
indicated.  
 The PI will evaluate patient safety and resolve any safety issues if necessary, as 
such issues arise. The PI will also be responsible for preparing written summary 
reports of adverse events and will prepare a written report summarizing any 
decisions that are made pertaining to participant disposition.  
 Data integrity and confidentiality will be safeguarded as discussed above in the 
Data Management and Statistical Analysis section under Research Methods.  
 
Monitoring Committee 
We will establish a monitoring committee and define in detail its role, its composition, and its 
operating procedures for reviewing patient safety and data from this study.  The monitoring 
committee, comprised of three individuals independent of personnel involved in the study, 

 
                                                                                                            
 
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including a psychiatrists and a statistician, will come together via conference call yearly. The 
committee will use a standardized approach employing contemporary bio statistical, 
psychiatric/psychological, and ethical principles to review study design and interim data every 
year. The committee will audit the records from the study and will ensure the data are being 
collected, managed and protected. The committee will have the ability to ask for more frequent 
reviews at any time if they deem it necessary. In addition, the PI will inform the committee of 
any serious adverse event.  
The PI will prepare a specific report for the committee in advance of each meeting. Attention 
will be given to data quality and timeliness, recruitment, risk versus benefit, adverse events and 
other factors that could affect study outcome.  
3. Reporting Adverse Events 
 Any serious adverse event will be reported to the Institutional Review Board 
(IRB) at the University of Chicago in a full written report within 10 working days 
of the event. For fatal/life-threatening serious adverse events, the PI will notify 
the IRB Chair by phone immediately. 
 Any moderate adverse event which appears definitely, probably, or possibly 
related to study participation will be reported to the University of Chicago IRB in 
writing within 20 working days. 
 Any mild adverse event will be summarized in the IRB annual progress reports. 
 
Statistical Analysis 
 
Design/Randomization 
The study is a double-blind, placebo-controlled study. Participants will be randomized (1:1) to 
receive dronabinol or placebo by the University of Chicago Investigational pharmacy in block 
sizes of eight, using computer-generated randomization with no clinical information.  
 
Due to the pandemic of COVID19, study participants can perform their baseline and follow-up 
visits online using encrypted Zoom instead of in person visits. All inventories will be assessed. 
Blood samples and urine toxicology, however, will be at the discretion of the study PI. In cases 
where they are considered medically necessary, the participant can have them drawn locally and 
submitted to the study team. 
 
Efficacy Analysis 
For statistical analysis, the full-analysis set will be defined as all participants who took at least 1 
dose of the study drug and had at least 1 post-randomization primary efficacy assessment. The 
safety-analysis set will be defined as all randomized participants who took at least 1 dose of the 
study drug and completed at least 1 post-randomization safety assessment.  Participants with 
trichotillomania and skin picking disorder will be grouped as one BFRB group. 
 
We will compare the baseline characteristics of both groups using Fisher’s exact test for 
categorical variables and the t test for continuous variables. We will calculate adherence to 
treatment, based on the number of pills returned at each visit, as the number of 
pills taken divided by the number of days in the study × 100%. 
 
Primary endpoint analysis 

 
                                                                                                            
 
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The primary outcome measure will be the change from first randomization visit to study 
endpoint in total composite score on the NIMH Trichotillomania Symptom Severity Scale(s) and 
the Sheehan Disability Scale.  
 
The primary analysis of efficacy for continuous measures will be analysis of variance (ANOVA), 
with terms for treatment to assess differences between treatment groups in the change from first 
randomization visit to endpoint using the last observation carried forward. The primary analysis 
for global improvement and response categories will be the Cochran-Mantel-Haenszel test using 
the last observation carried forward. The primary analysis for ≥5% reduction in weight will be 
Fisher’s exact test using the last observation carried forward.  
 
Secondary endpoints analyses 
Secondary outcome measures will include the change from first randomization visit to study 
endpoint in CGI severity and improvement scales, self-reported hair pulling behavior using the 
MGH-HPS, self-reported skin picking behavior using the SP-SAS, the change in depressive and 
anxiety symptoms, change in quality of life, and impacts on personality markers. We will use a 
longitudinal analysis comparing the rate of change of the outcome during the treatment period 
between groups. The difference in rate of change will be estimated by random regression 
methods.  The model for the mean of the outcome will include terms for treatment, time, and 
treatment-by-time interaction. To account for the correlation of observations within participants, 
we will use SAS procedure MIXED with a first-order antedependence covariance structure. The 
longitudinal analyses will use all available observations from all time points from all participants 
who completed a randomization visit evaluation.  
 
Safety analyses 
We will evaluate differences between groups in the incidence of treatment-emergent adverse 
events using Fisher’s exact test. Descriptive statistics will be used to evaluate changes in 
laboratory values, blood pressure and heart rate.  
 
Sample Size 
The sample size was calculated for the co-primary endpoint of change from randomization. For 
80% power to compare the change from randomization, assuming a true effect size of 0.5 
between treatment group and the placebo group, 50 participants with a BFRB will be needed in 
each treatment group based on a 2-group t test at the .05 level of significance. Given the low 
rates of adverse events expected with dronabinol, we expect few drop-outs from the study and 
therefore a smaller sample is needed.  
 
Data Management Plan 
Data collected will consist of demographic data, subjective (self-report questionnaires, interview 
responses, ratings), and physiological (weight, heart rate and blood pressure). Access to 
individually identifiable private information about human subjects will be limited to Dr. Grant 
and their staff and will be collected specifically for the proposed research project. All collected 
data will be stored utilizing a 4-digit subject identification code, linked to separately stored 
identifying information via a coded log only available to the PI.  
 

 
                                                                                                            
 
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The gender ratio of trichotillomania and skin picking disorder have been estimated to be 
approximately 3:1 (female:male).  We will also make every effort to include a racially/ethnically 
diverse study population. The year 2010 Chicago census is 2,695,598 (US Census Bureau, 2011). 
The year 2010 Chicago race distribution is as follows: white 47.1%, African/African-American 
33.9%, Asian/Asian-American 6.2%, Native American 1.0%, or other race/not identified 
(11.8%). A total of 28.9% of the population also identified as Hispanic/Latino allowing for a 
diverse population sample (year 2010, US Census Bureau, Chicago, IL). We will make every 
effort to ensure that members of both genders and diverse racial, ethnic, and socioeconomic 
groups are adequately represented in the proposed study. 
 
The PI will implement the following procedures to ensure data integrity and the safety of 
participants during the study: A number of elements of the research plan are intended to 
minimize the risks of study participation. For example, the study exclusion criteria exclude 
patients who are experiencing clinically significant suicidality or require a higher level of care 
than outpatient. If this is indicated, the PI will evaluate them and refer them for immediate non-
study treatment (for example, inpatient or additional pharmacologic treatment).  The PI will 
carefully monitor ratings on the Columbia Suicide Severity Rating Scale and the Hamilton 
Depression rating Scale; any participant endorsing suicidal thoughts, will be immediately 
evaluated by the PI and referred to a higher level of care if clinically indicated. The PI will 
evaluate patient safety at each visit and resolve any safety issues more frequently if necessary, as 
such issues arise.  The PI will also be responsible for preparing written summary reports of 
adverse events and will prepare a written report summarizing any decisions that are made 
pertaining to participant disposition.  
 
 
Ethical Considerations 
This study will be conducted according to US and international standards of Good Clinical 
Practice (FDA regulations 21 CFR 312 for IND studies and FDA guidance E6) for all studies.  
Applicable government regulations and University of Chicago research policies and procedures 
will also be followed. 
 
This protocol and any amendments will be submitted to the University of Chicago Institutional 
Review Board (IRB) for formal approval to conduct the study.  The decision of the IRB 
concerning the conduct of the study will be made in writing to the investigator.   
 
All subjects for this study will be provided a consent form describing this study and providing 
sufficient information for subjects to make an informed decision about their participation in this 
study.  This consent form will be submitted with the protocol for review and approval by the 
IRB.  The formal consent of a subject, using the IRB-approved consent form, will be obtained 
before that subject is submitted to any study procedure.  This consent form must be signed by the 
subject and the investigator-designated research professional obtaining the consent.  
 

 
                                                                                                            
 
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