Clinical trial NCT03539432
Conditions: Alcohol Use Disorder
Sponsor: The Mind Research Network
Start date: 2018-05-16; Completion date: 2018-12-30
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the efficacy of the medication gemfibrozil in reducing alcohol consumption in individuals with an alcohol use disorder who are seeking treatment for alcohol-related problems. Twenty individuals will be randomized to receive four weeks of either gemfibrozil or placebo and retrospective reports of alcohol use will be collected throughout the trial. In addition, brain imaging measures will be collected at baseline and after two weeks of treatment to determine the effects of gemfibrozil on brain functioning.

Detailed description:

Arms: arm 1: Gemfibrozil 600 mg by mouth twice daily arm 2: Microcrystalline cellulose powder packaged in capsules identical to the experimental condition
Interventions: intervention 1: Gemfibrozil 600 MG intervention 2: Placebo oral capsule
Intervention descriptions: intervention 1: Gemfibrozil capsules (600 mg) taken twice per day intervention 2: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication

Protocol documents:
Prot_SAP_002.pdf: 
1 
 
 
 
Cover Page 
 
 
 
 
 
 
 
Title: Exploration of Gemfibrozil as a Treatment for AUD 
 
Clinical Trial Number: NCT03539432 
 
Protocol Document Date: 6/27/2018


2 
 
1) Protocol Title (Version 1.1) 
Exploration of gemfibrozil as a treatment for AUD 
2) Principal Investigator 
Eric Claus, Ph.D., The Mind Research Network, 505-515-1556, eclaus@mrn.org 
3) IRB Review History 
N/A 
4) Objectives 
In this pilot study, we propose to randomize 20 participants with Alcohol Use Disorder 
(AUD) to treatment with either placebo or 600 mg of gemfibrozil twice daily for 4 weeks 
in a double-blind placebo-controlled, clinical trial. Participants will receive 4 sessions 
of motivational enhancement therapy (MET)37, regardless of medication assignment. 
Brain responses during response inhibition, stress, and alcohol cue reactivity will be 
measured with fMRI obtained at baseline and 2 weeks. Triglyceride levels will be 
obtained at baseline, 2 and 4 weeks. The protocol will be registered on clinicaltrials.gov.  
Aim 1: To investigate the effects of gemfibrozil on alcohol use at 4 weeks in 
individuals with AUD. We hypothesize that relative to placebo, gemfibrozil will 
improve alcohol use outcomes as defined by rate of change in drinks per drinking day 
(DPDD), drinks per week (DPW) and percent days abstinent (PDA). Effect sizes for all 3 
metrics will be calculated to determine if a larger clinical trial is warranted.  
Aim 2: To investigate the effects of gemfibrozil on various possible biological targets 
which are increasingly recognized as important mechanisms by which treatments 
for AUD work. In particular we hypothesize that gemfibrozil will result in 1) increased 
engagement of cognitive control networks (inferior frontal gyrus (IFG) and dorsal 
anterior cingulate cortex (ACC)) during response inhibition, 2) decreased response in 
networks involved in reward (ventral and dorsal striatum, ACC) during the presentation 
of alcohol cues, 3) decreased response in networks that process negative affect 
[amygdala, insula, and ventromedial prefrontal cortex (PFC)] in response to emotional 
pictures, and 4) reduced triglyceride levels. We also hypothesize that changes in these 
targets will mediate the effects of gemfibrozil on alcohol use at 4 weeks.  
 
5) Background 
Alcohol dependence accounts for 4% of the global disease burden1, and has significant individual and 
societal costs1.  While three FDA approved medications are available for the treatment of AUD, effect 
sizes tend to be modest, and findings do not replicate from study to study2-6.  Identifying additional 
treatments for AUD is sorely needed in order to improve the number of options available to prescribe 
to patients with an AUD.  
 
Peroxisome proliferator-activated receptors (PPARs) are nuclear hormone receptors that 
heterodimerize with the retinoid X receptor, which, in combination, are able to modify the 
transcription of target genes within the cell nucleus 39. There are three main classes of PPARs 
including a, b/d, and g, which are distributed throughout the body including the brain. In fact, PPAR 
a and d are both expressed highly in regions within reward networks including nucleus accumbens, 
ventral tegmental area, and amygdala and also in prefrontal cortex, which may suggest a potential 
effect on executive control.  PPAR a agonists show potential for beneficial effects on depression9,10, 
neuro-degeneration11,12, learning and memory deficits following ischemia13, pain14 epilepsy15,16 


3 
 
obesity17 and inhibition/cognitive control18. Fibrate medications (fenofibrate, gemfibrozil), which are 
derivatives of fibric acid, are a class of medications commonly used in the treatment of 
hypercholesterolemia (especially hyperlipidemia Type III, due to its effect of lowering very low 
density lipoprotein) and are widely used to reduce peripheral levels of triglycerides40,41.  Fibrates are 
also agonists at the PPAR a receptor. 
 
Not surprisingly, these medications are now being explored for the treatment of addictive disorders, 
and particularly AUD. There have been some promising results from preclinical trials suggesting that 
PPAR a agonists may reduce drinking19-22.  Blednov et al found that fenofibrate administration 
reduced ethanol consumption in both continuous and intermittent 2-bottle choice tests in male mice, 
although no effect was found for females20. In addition, fenofibrate and tesaglitazar administration 
reduced novelty responses and  increased acute withdrawal, and fenofibrate increased conditioned 
taste aversion, all of which could explain reductions in drinking21. In a separate set of studies, 
administration of pioglitazone, a PPAR g agonist, reduced drinking and alcohol seeking in rats42. 
Also, inadvertent reductions in alcohol consumption have been observed in trials of gemfibrozil for 
triglyceride reduction in humans43.  A phase 2 clinical trial of fenofibrate administered over 9 days in 
non-treatment seeking individuals with at least a moderate AUD was recently completed, looking at 
effects of fenofibrate on cue induced craving and drinking (clinicaltrials.gov/ct2/show/ 
NCT02158273). However, based on results posted on clinicaltrials.gov, findings were not robust. 
However, no clinical trials to date have focused on testing the effect of gemfibrozil on drinking 
related outcomes in human subjects with AUDs.  
 
Gemfibrozil may have some advantages over fenofibrate, and thus warrants further study. For one, 
although fenofibrate is more widely used due to its greater efficacy in reducing triglycerides44, 
smaller effects on the CYP450 system, and lower risk for rhabomyelisis, gemfibrozil may have less 
liver toxicity, and both medications are equally safe29. Moreover, although fenofibrate showed some 
promise in animal models for nicotine use reduction26,27, it did not reduce smoking in humans and 
only modestly reduced smoking withdrawal28. Importantly, fenofibrate may have limited ability to 
cross the blood brain barrier23, whereas preclinical studies have shown that gemfibrozil definitively 
increases binding to PPAR receptors in the brain24,25. Gemfibrozil reaches peak plasma concentrations 
in humans in one to two hours post-administration and in rats, effects on gene expression are 
detectable in cortex within three days of use39 suggesting a relatively fast-acting agent.  
 
Potential targets of gemfibrozil.  While the precise mechanisms of action in the brain have not been 
identified with PPAR a agonists, some preliminary evidence points to mechanisms that may be 
particularly important for AUDs, which may affect circuits involved in cue reactivity, cognitive 
control, and/or negative affect. Behavioral and cognitive control: PPAR a agonist treatment in mice 
improves cognitive flexibility and inhibition in a pharmacological model of ketamine-induced 
behavioral disinhibition and repetitive behavior in mice genetically predisposed to have repetitive 
behavior18. Stress reactivity: PPARα agonists have also been found to be associated with reduction in 
depressive behaviors in mice induced by lipopolysaccharide and in normal C57BL/6J mice9,10. 
Alcohol Cue Reactivity: Leptin transport across the blood brain barrier appears to be targeted by 
gemfibrozil45. Prior studies have demonstrated elevated levels of leptin in individuals with an AUD, 
and that these levels drop significantly after 1-2 weeks of abstinence from alcohol.  Given the role of 
leptin in signaling satiety, increasing leptin transport could reduce craving and urges to drink. In 
addition to the effects on leptin transport, administration of gemfibrozil and other PPAR a agonists 
may affect function of neural networks involved in motivation and reward that are highly relevant to 
AUDs. Administration of PPAR a agonists influences gene expression in the amygdala, with a focus 
on GABAergic interneurons46. Activation of PPAR a receptors is associated with reduced firing of 
dopamine cells in the VTA as a result of altered activity of nicotinic acetylcholine receptors47,48. 


4 
 
Triglycerides: The mechanisms by which fibrates reduce triglycerides is not fully understood; 
however, possible candidate mechanisms include via its effect on PPAR a in the liver, which 
regulates gene expression of enzymes involved in fatty acid oxidation49, through changes in hepatic 
apolipoprotein CIII expression50, through inhibition of triglyceride synthesis in the liver51, by 
enhancing clearance of triglycerides41,52,53, and potentially even through effects on dietary choice43. 
 
6) Inclusion and Exclusion Criteria 
Individuals with AUD who are seeking treatment to reduce their drinking (N=40) will be 
recruited from the community through advertisements placed in local newspapers, radio 
stations, movie theatres, online forums, and flyers, word of mouth, and email 
communications directed towards community support groups.    
 
Inclusion Criteria 
1) males and females age 18-60 meeting DSM-V criteria for moderate or severe AUD in 
the past year 
2) interested in cutting down or quitting drinking 
3) able to provide voluntary informed consent 
4) have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in 
the past 30 days 
 
Exclusion Criteria 
1) severe liver disease; severe kidney disease; gallbladder disease or gallstones  
2) chronic renal or hepatic failure 
3) recent pancreatitis 
4) insulin-dependent diabetes 
5) other urgent medical problems 
6) moderately elevated liver function tests (AST or ALT greater than 2 times upper limit 
of normal) or elevated creatine kinase (CK) 
7) schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the last 
month 
8) current moderate or severe other substance use disorder (SUD; except nicotine or 
marijuana) 
9) active legal problems with the potential to result in incarceration 
10) pregnancy or lactation, or child bearing age and not on birth control or not willing to 
use other birth control methods (e.g. condoms) 
11) current daily use of anti-craving medications, mood stabilizers, benzodiazepines, or 
anti-psychotics 
12) regularly taking a medication contraindicated for use with gemfibrozil including 
other fibrates, statins, repaglinide, or which are believed to interact with gemfibrozil such 
as dasabuvir, dabrafenib, loperamide, montelukast, paclitaxel, pioglitazone, rosiglitazone, 
colestipol, colchicine and warfarin41,68 
13) a history of alcohol withdrawal-induced seizures or delirium tremens (hallucinations, 
disorientation) requiring hospital admission during the last ten years 
14) a history of moderate or severe traumatic brain injury (TBI; loss of consciousness 
>30 minutes69) 
15) left-handedness  
16) any contraindications for MRI 
 


5 
 
7) 
Multi-Site Research 
N/A 
8) 
Study Timelines 
Individual participant’s involvement will last ~15 hours over 6 weeks, which includes 4 weeks of 
medication/placebo.  We anticipate ongoing enrollment of participants for approximately 12 
months. 
9) Study Endpoints 
The study will close enrollment once 20 participants have been randomized.  Based on 
previous medication trials for AUDs, we expect ~70-80% of participants will complete at 
least two weeks of the medication, which will be sufficient for deriving initial effect size 
estimates.   
10) 
Study Methods  
Participants will be asked to complete the following procedures: 
Screening visit 
After the participant has reviewed and signed the consent form, breath alcohol will be measured 
(<.01 required), participants will complete a 90 day timeline follow-back (TLFB)71 to establish 
adequate drinking levels for inclusion, a handedness questionnaire72, and a MRI safety screener to  
assess eligibility. In addition, participants will be interviewed using portions of the Structured 
Clinical Interview (SCID) for Psychotic, Anxiety, Mood, and Drug and Alcohol Use Disorders70 
to establish whether they have moderate to severe AUD and/or exclusionary SUD and psychiatric 
disorders. In addition, all participants will complete a urine drug screen and female participants 
will complete a urine pregnancy test. In addition, trained research staff will conduct a blood draw 
to obtain baseline levels of CBC, LFT’s, BMP, triglycerides, GGT, and CK. Expected time: 2 
hours 
Medical history visit 
If participants are eligible based on the screening visit, a subsequent visit will be scheduled for 
the study physician to conduct a physical examination and medical history. If not already 
completed at the screening visit (visit 1), trained research staff will conduct a blood draw to 
obtain baseline levels of CBC, LFT’s, BMP, triglycerides, GGT, and CK.  Expected time: 2 hours 
Baseline visit 
Participants who are deemed medically eligible for the study will be scheduled for a baseline 
appointment during which participants will complete assessments, a baseline MRI session, and 
the first motivational enhancement therapy (MET) session and will receive medication along with 
instructions for taking the medication. Expected time: Assessments (2.5 hours), MRI (1 hour), 
MET session (.5 hours), medication dispensing/instructions (.5 hours) 
 
Baseline Assessments.  We will collect measures of craving (Penn Alcohol Craving Scale 
(PACS), impaired control over drinking (Impaired Control Scale), alcohol dependence severity 
(Alcohol Dependence Scale)96, nicotine dependence (Fagerstrom Test for Nicotine 
Dependence)97, hazardous drinking (AUDIT)98, intelligence (WTAR99), emotional regulation 
(Difficulties in Emotion Regulation Scale (DERS), State Difficulties in Emotion Regulation Scale 
(S-DERS), and Emotion Regulation Questionnaire (ERQ))103,104, treatment alliance105 (obtained at 
the end of each therapy session), motivation (Stages of Change Readiness and Treatment 
Eagerness Scale(SOCRATES)106) and outside treatment-seeking (Treatment Services Review107).  
In addition, we will collect a demographics form and a locator form to facilitate tracking of 


6 
 
participants.  Withdrawal will be measured using the Clinical Institute Withdrawal Assessment 
for Alcohol (CIWA); if participants are experiencing clinically significant active alcohol 
withdrawal (CIWA>873), they will be asked to have their withdrawal treated before returning to 
initiate treatment.  The Digit Span test will be used to measure working memory.  To measure 
tendency to discount future rewards, we will use the Monetary Choice Questionnaire (MCQ) 
which presents participants with choices between immediate rewards and larger, delayed rewards 
(e.g. $10 today vs. $27 in two weeks).   Depression, anxiety, and anger will be measured using 
the PROMIS measures of these constructs. The Drinker Inventory of Consequences (DrInC) will 
be administered to assess negative consequences from drinking; the results from this 
questionnaire will be used in the MET sessions.  Finally, participants will complete a urine drug 
screen (all participants) and pregnancy test (females only).  
 
An emotional working memory task will be used to assess working memory in the presence of 
emotional distractors (Marx et al, 2014).  In the task, participants are instructed to remember 
letters that are superimposed onto negative, neutral, or positive pictures and judge whether the 
current letter matches the letter 1-back or 2-back.  The total amount of time required for the task 
is ~12 minutes.   
 
Functional MRI (fMRI).  Participants will complete measures of neurocognitive function 
while undergoing fMRI that require a response after the onset of a visual or auditory stimulus. 
These stimuli may include pictures of alcohol or other beverages, emotional pictures (positive, 
neutral, negative), and different shapes (e.g. arrows, circles, squares).  In addition, we will collect 
a rest scan, which requires participants to focus on a fixation cross.   
Arterial Spin Labeling Perfusion Sequence (ASL).  Quantification of cerebral blood flow 
(CBF) will be measured using arterial spin labeling (ASL). Because the BOLD signal may be 
influenced by CBF in general, we routinely collect ASL (which only adds about 5-7 minutes to 
the scan time) in order to assess and potentially control for general differences in CBF.   
Structural MRI (sMRI). We will acquire a high-resolution protocol sufficient to permit 
accurate tissue classification and anatomical parcellation. 
 
Intervention 
Participants who meet study criteria will be randomized to active treatment or placebo. The 
placebo group will receive capsules (filled with microcrystalline cellulose powder) which look 
identical to capsules filled with active treatment, and will receive the same number of capsules as 
for active treatment. Members of the study team will be blinded to study randomization; the study 
pharmacist and/or another honest broker at MRN (e.g. member of the Research Operations team) 
will be un-blinded, and the pharmacist will not interact with any of the participants. Gemfibrozil 
will be prescribed at 600 mg by mouth twice daily, which is the standard FDA approved dose 
used for the treatment of hypertriglyceridemia. Adherence will be monitored with bi-weekly pill 
counts. At the first med dispensing visit (30 minutes, baseline), participants will receive basic 
information about possible side effects and will be provided with a 2-week supply. During the 
follow-up med dispensing visit at Visit 5 (15 minutes), individuals will undergo a review of side 
effects.  
All individuals will also receive 4 sessions of motivational enhancement therapy (MET)37, thus 
reducing ethical concerns of non-treatment. Therapists will be trained by a MINT-trained trainer.  
Visit 4 
One week after starting medication, participants will complete the second MET session. In 
addition, participants will complete TLFB, PACS, Helping Alliance Questionnaire, and the 
CIWA.  Expected time: 30 minutes 


7 
 
Visit 5 
Two weeks after starting medication, an additional two weeks of medication will be dispensed, 
the third MET session will take place, and a follow-up MRI scan (identical to baseline scanning 
session), blood draw, and assessments will take place.  The blood draw will be used to measure 
LFT’s, GGT, and triglyceride levels.  Assessments will include the CIWA to measure 
withdrawal, the ICS to measure impaired control, the PACS to measure craving, the TLFB to 
measure drinking, the Helping Alliance Questionnaire, and medication side effects.  Expected 
time: MET (30 minutes), MRI (1 hour), Med dispense (30 minutes), Assessments/blood draw (1.5 
hours) 
 
Visit 6 
Four weeks after starting medication, the fourth MET session will take place as well as a blood 
draw and assessments.  The blood draw will be used to measure assess LFT’s, GGT, and 
triglyceride levels.  Assessments will include the CIWA to measure withdrawal, the ICS to 
measure impaired control, the PACS to measure craving, the TLFB to measure drinking, the 
Helping Alliance Questionnaire, and medication side effects.  Expected time: MET (30 minutes), 
Assessments/blood draw (2 hours) 
 
Phone Call 
Six weeks after starting medication, a phone assessment will be used to collect TLFB and PACS 
data and side effects/other symptoms that may be associated with terminating use of the 
medication.  Expected time: 30 minutes 
 
For all questionnaires listed above, participants may refuse to answer any question at any time.  
Direct identifiers will be collected and maintained in the MRN COINS database.  All data 
collected as part of this study will be coded with a Unique Research Subject Identifier (URSI). 
 
 
Instrument/Activity 
Screen 
(Visit 
1) 
Screen 
(Visit 2) 
Baseline 
(Visit 3)  
Visit 4 
Visit 5 
Visit 6 
Phone 
Call 
Breathalyze 
X 
 
X 
 
X 
 
 
SCID 
X 
 
 
 
 
 
 
TLFB 
X 
 
X 
X 
X 
X 
X 
MRI Screener 
X 
 
X 
 
X 
 
 
Edinburgh 
Handedness 
X 
 
 
 
 
 
 
Urine Drug Screen 
X 
 
X 
 
X 
 
 
Pregnancy Test 
X 
 
X 
 
X 
 
 
Exclusion 
Criteria 
List 
 
X 
 
 
 
 
 
Medical History 
 
X 
 
 
 
 
 
Physical Exam 
 
X 
 
 
 
 
 
Blood draw 
 
X 
 
 
X 
X 
 
PACS 
 
 
X 
X 
X 
X 
X 
ICS 
 
 
X 
 
X 
 
 
CIWA 
 
 
X 
X 
X 
X 
 
ADS 
 
 
X 
 
 
 
 


8 
 
FTND 
 
 
X 
 
 
 
 
AUDIT 
 
 
X 
 
 
 
 
WTAR 
 
 
X 
 
 
 
 
DERS 
 
 
X 
 
 
 
 
S-DERS 
 
 
X 
 
 
 
 
ERQ 
 
 
X 
 
 
 
 
PROMIS Anger 
 
 
X 
 
 
 
 
PROMIS 
Depression 
 
 
X 
 
 
 
 
PROMIS Anxiety 
 
 
X 
 
 
 
 
MCQ 
 
 
X 
 
 
 
 
Emotional WM 
 
 
X 
 
 
 
 
Digit Span 
 
 
X 
 
 
 
 
DRINC 
 
 
X 
 
 
 
 
Helping 
alliance 
Questionnaire 
 
 
X 
X 
X 
X 
 
SoCRaTES 
 
 
X 
 
 
 
 
Treatment Services 
Review 
 
 
X 
 
 
 
 
Demographics 
 
 
X 
 
 
 
 
Locator 
 
 
X 
 
 
 
 
MRI 
 
 
X 
 
X 
 
 
Motivational 
Enhancement 
Therapy 
 
 
X 
X 
X 
X 
 
Medication 
Dispensing 
 
 
X 
 
X 
 
 
Medication Dosing 
Handout 
 
 
X 
 
 
 
 
Medication Count 
 
 
 
X 
X 
X 
X 
SAFETEE/Adverse 
events 
 
 
 
X 
X 
X 
X 
Total time (hours) 
2 
2 
4.5 
.75 
3.5 
2.5 
.5 
Total Payment 
$20 
$20 
$60 
$10 
$80 
$50 
$10 
 
 
 
11) 
List of Appendices 
ADS.doc 
AUDIT.doc 
CIWA-Ar_101515.docx 
Demographics_031218.doc 
difficultiesinemotionalregulation_scale.pdf 
DrInC.pdf 
Edinburgh_v09022015.doc 
ERQ.pdf 
Fagerstrom Test for Nicotine Dependence (FTND).doc 
HelpingAllianceQuestionnaire_paper.pdf 
ICS-Followup.docx 


9 
 
ICS-Initial.docx 
MCQ_100115.docx 
MRI Screening Form_no contrast_5.7.15.pdf 
Penn Alcohol Craving Scale.doc 
PROMISAnger.pdf 
PROMISAnxiety.pdf 
PROMISDepression.pdf 
SOCRATESv8.pdf 
StateDERS.docx 
TLFB.docx 
Treatment Review Questionnaire_last 30 days.doc 
 
AdherenceHandoutPatient.docx 
all_scid.pdf 
Breathalyzer_UA_PregnancyResults.doc 
ConcurrentMeds.doc 
DigitSpan.docx 
Exclusion Criteria Checklist Gemfib.docx 
Locator_030918.doc 
PhoneScreen_031318.docx 
Physical Exam.doc 
SAE_initial.pdf 
SAFTEEgemfib.doc 
VitalsBaseline.docx 
WTAR word card.pdf 
 
RecruitmentMaterials_flyer_v1.docx 
RecruitmentMaterials_flyer_v2.docx 
RecruitmentMaterials_text_advertisement_v031118.docx 
 
gemfibrozilINDexempt.pdf 
gemfibrozil_patient_brochure.pdf 
 
12) 
Data and Specimen Banking 
No specimens will be banked as part of this protocol.  Participants will be given the option of 
having their data stored in the MRN Data Repository (see HRRC# 06-387, PI: Roberts). 
13) 
Data Management 
Consent Forms: Signed consent forms are stored in a locked cabinet in a locked office at MRN. 
Questionnaire Data: All data are coded with a unique research subject identifier (URSI) number.  
Electronic data is stored on a drive only accessible by the research team on a secure MRN server.  
For non-computer based forms, such as the neuropsychological assessments, the data collection 
sheets are stored in a locked cabinet in a locked office at MRN. 
Behavioral and Imaging Data: All data is coded with the URSI, and collected and stored 
electronically.  Electronic data is stored on a drive only accessible by the research team on a 
secure MRN server.  De-identified data resulting from this study may also be presented at 
meetings, published in journals/books, used in classrooms for training/teaching purposes, and 
may be shared with other researchers including scientists at other universities and institutions. 


10 
 
Study Closure: At the time of study closure, all participant identifiers (name, address, etc.) will be 
made inaccessible to the research team. MRN retains the link between identifiers and URSI 
indefinitely for the potential future benefit to the research participant. Specifically, it may become 
medically advantageous in the future for a former participant to have access to the clinical 
information that may be present in radiological scans and reviews. For example, if a participant 
has been diagnosed with a neurological condition (e.g., multiple sclerosis, glioblastoma, etc.) it 
may be clinically beneficial for the participant’s physician to have access to a research scan that 
was performed at an earlier time-point to determine disease course and severity. 
 
In addition to the above protections, we have applied for a Certificate of Confidentiality from 
NIH to further protect subject confidentiality. Upon receipt of the CoC, we will revise the consent 
to include language that specifies that the investigators have obtained a CoC. Importantly, as 
stated in the consent, participants are informed that if they report current abuse of a child or an 
elder, we will report the person to the proper authorities, consistent with New Mexico state law. 
 
Statistical Analysis: All MRI data will undergo standard preprocessing (e.g. motion correction, 
spatial normalization) and quality control prior to statistical modeling. Drinking data and other 
measures will be analyzed using standard statistical analyses including linear mixed models and 
the general linear model.   
Because the proposed study is a pilot study, we will not likely have sufficient power to detect 
significant effects.  However, we will be able to compute effect sizes for larger trials if the effects 
look promising. 
14) 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
General Considerations: The risks are greater than minimal risk (see section 17 for anticipated 
risks).  
 
Every effort will be made to identify and address adverse events as they arise from the medication 
treatment. At each in person follow up visit, study staff will complete the side effects checklist 
with participants, monitoring for any changes in anticipated side effects; these side effects will be 
relayed to the study physician within 1 business day.  The study physician will be allowed to 
decrease the dose, or discontinue the study medication as deemed necessary. Similarly, every 
effort will be made to address adverse events as they arise from the assessments including anxiety 
from exposure to affective or alcohol stimuli. If there are any serious adverse events we will take 
appropriate measures. 
 
If a participant does experience excessive craving or anxiety as a result of the assessments, or 
neuropsychological testing, or expresses suicidal thoughts, Dr. Wilcox or covering medical 
provider will be available at any time to assess safety and make an attempt to help the patient. 
Although no aspects of the study are expected to be unduly upsetting or risky, established 
procedures are in place for the occurrence of such an emergency. Support will be available to deal 
with any anxiety, fatigue or increased urge to use alcohol associated with behavioral testing. 
There will a physician available any time by phone to talk with participants for any emergent 
medical adverse events from the medication. A standardized suicide risk assessment protocol is 
in-use by this team to assess for safety when participants report past or current suicidal thoughts, 
and Dr. Wilcox or covering medical provider will be called, and one of them will be available at 
any time to respond, if the protocol warrants their involvement. 
 
Every effort will be made to protect the confidentiality of participants’ records. However, 
complete confidentiality of records cannot be guaranteed as records may be examined by 
authorized personnel from the approving IRB, the FDA and MRN. Otherwise, records will be 


11 
 
kept strictly confidential and will not be inspected by any other agency unless required by law. 
Loss of confidentiality will be minimized by assigning a randomized number to each participant 
upon entry into the study. This number will be used for all correspondence between study 
investigators and all data collection and analysis after the initial screening visit. MRN has state-
of-the art IT networks with all necessary security mechanisms in place for data storage. Any 
personal information entered into computers is password protected and monitored for suspicious 
activity. Moreover, all information will be in double-locked rooms per privacy specifications. The 
results of this research may be presented at meetings or in publications; however, participants’ 
identity will not be disclosed.  
 
Participants will be clearly informed of their right to withdraw from the study at any time and still 
receive full compensation for the time they participated. 
 
There are no known health risks associated with the proposed MRI aspect of the study. A two-
way intercom system and a video monitoring system provide continual monitoring of the 
participant’s condition at all times. If discomfort or concern is expressed, or detected, the 
experiment will be stopped and the participant will be given the option to discontinue at any time. 
Absolute caution will be implemented to ensure that only non-ferrous objects are present during 
all of the MRI sessions. Participants will be asked to change into hospital scrubs prior to being 
placed in the scanner to ensure that they do not introduce any metallic objects into the imaging 
environment. Participants will also be screened for the presence of a pacemaker or any other 
metallic objects in their body, such as an aneurysm clip, ear implant, or nerve stimulator. 
Participants with these or other metallic devices will not be allowed to participate in any of the 
previously described studies. The MRI also makes loud ‘drum’ beating noises during the study.  
Headphones or earplugs are provided for protection. 
 
Data and Safety Monitoring Committee: Data and Safety Monitoring Committee will be 
established comprising the PI, study physician, research coordinator, and an external physician 
reviewer who is not otherwise affiliated with the study and does not report directly or indirectly to 
the PI. This committee will meet quarterly to review data quality, recruitment and retention, and 
to review all serious or clinically significant adverse events.  In addition, the committee will 
review safety data, and follow-up on any serious adverse event that appears to be study related. 
The DSMC members will be blinded for participants who are currently enrolled. For all SAE’s, 
investigators will consider and discuss the need for unblinding, based on the nature of the SAE, 
and based on whether or not knowing the group assignment would alter treatment of the SAE, 
within 48 hours. Patterns of adverse events as well as individual events may indicate the need for 
operational changes, protocol modifications, a decrease in dose, or, conceivably, discontinuation 
of the trial.  
 
All side effects and adverse event information will be monitored for using a standardized 
checklist at all medication visits with the nurse or research coordinator. Study data will be 
reviewed quarterly, or more frequently as deemed necessary by the PI and study physician.  
 
Adverse events (AEs) will be collected on an AE case report form when they come to the 
awareness of study staff. The form will include an assessment of clinical significance and study 
relatedness.  AEs will be reported in accordance with federal law and policies and the IRB.  
Reporting procedures vary depending on the severity of the AE, and will follow the policies in 
the IRB manual.  In particular, adverse events and other reportable events that are unanticipated 
and deemed related to research procedures and that result in greater risk of harm will be reported 
to the IRB within 7 days of discovery, regardless of whether they qualify as SAEs.   
 


12 
 
Serious Adverse Events: Adverse events (AEs), when present, will be collected on an AE case 
report form at the end of each drug administration session and at all subsequent visits. The form 
will include an assessment of clinical significance and study relatedness.  Serious Adverse Events 
(SAEs) will be documented on a separate SAE form. SAEs will be reviewed by the Data and 
Safety Monitoring Committee at its quarterly meetings. These will also be reported to IRB within 
48 hours.  
 
15) 
Participant Complaints 
If a participant wishes to issue a compliant or request information about the research, they may 
notify any study team member or the PI, Eric Claus, at (505) 272-5028, Monday – Friday from 
8am – 5pm.  Participants may also contact the UNM Office of the IRB, (505) 277-2644, 
irbmaincampus@unm.edu. Website: http://irb.unm.edu/ 
Depending on the nature of the complaint, the problem will be resolved directly with the 
participant, if possible, in a confidential and timely manner. Complaints that constitute a 
reportable event will be submitted to the IRB within 7 days. Participant complaints will be coded 
with a unique research subject identifier (URSI) and kept in their respective study folder in a 
locked office for record-keeping purposes.  
 
16) 
Withdrawal of Subjects 
Participants may withdraw from the study at any time.  All unused study medication can 
be returned to study staff who will return it to the pharmacist for proper disposal. 
17) Risks to Subjects 
Gemfibrozil: The risks of the medication are greater than minimal risk. There are three main 
safety concerns of gemfibrozil in adults: self limited transaminitis4, gallstones and 
rhabdomyelisis2. Our methods will allow us to explore for any adverse events in these and 
unexpected areas, and we will be aggressive about checking liver tests and following up 
concerning symptoms. We are also checking CK levels (for subclinical rhabdomyelisis) at 
baseline. To our knowledge there have been no clinical reports of the combinations of 
gemfibrozil and alcohol causing significant problems, and gemfibrozil is not contraindicated in 
individuals who also drink alcohol2, although patients are warned about the risks of alcohol 
counteracting the triglyceride lowering effects in the package insert2. Moderate amounts of 
alcohol co-administered with gemfibrozil in rats did not cause alterations in LFTs and authors 
concluded that a moderate amount of alcohol with gemfibrozil is safe in rats5. Based on their 
association with gemfibrozil treatment in past work, stomach upset or pain, diarrhea, nausea, or 
vomiting will be monitored for using a standard checklist as well as symptoms of more serious 
side effects (right upper quadrant abdominal pain, nausea, vomiting would be concerning for 
gallstones; muscle aches or weakness, dark colored urine would be concerning for 
rhabdomyolisis)6. The FDA has determined this medication to be exempt from needing an IND 
(see attached IND exemption letter – gemfibrozilINDexempt.pdf).  
 
MRI:  Radio and magnetic waves associated with MRI scans are not associated with any known 
adverse effects. MRI is non-invasive and considered minimal risk by the FDA and OHRP. 
However, the scanner is a large magnet, so it could move objects containing ferrous metal in the 
room during the scan.  All participants are screened using the MRI safety screening form prior to 
be being scanned.  Participants may be bothered by feelings of claustrophobia (uncommon). The 
MRI also makes loud ‘drum’ beating noises during the study.  Headphones or earplugs are 


13 
 
provided for protection. Rarely, large or recent tattoos can heat up during an MRI scan and cause 
skin irritation like a sunburn (uncommon). No long-term harmful effects from MRI are known. 
However, since the effect of MRI on early development of the fetus is unknown, participants who 
are pregnant will not be allowed to go in the MRI. Females will be asked to take a urine 
pregnancy test before being allowed to participate in the study. The test results will only be 
shared with participant. All MRI sequences used are within FDA approved parameters, including 
specific absorption rate. Due to the very high sensitivity of MRI in detecting abnormalities, there 
is a risk of false-positive findings, identifying something on imaging studies that may or may not 
be important.  This may result in anxiety and a referral for additional medical testing, possibly 
including a recommendation for clinical scans at the participant’s cost. 
 
Blood drawing risks: Drawing blood may cause temporary pain and discomfort from the needle 
stick, occasional bruising, sweating, feeling faint or lightheaded and in rare cases infection or 
nerve pain. 
 
 
General (uncommon) risks: Participation in this study may result in discomfort, emotional stress, 
behavioral fatigue, and inconvenience. 
 
Privacy and Confidentiality:  Participation in this study may produce emotional stress, 
inconvenience or an invasion of privacy (uncommon).  There is also a risk of breach of data 
confidentiality (uncommon). 
There may also be side effects or risks to study participation that are unforeseen and not known at 
this time. 
 
18) Potential Benefits to Subjects 
Participants may or may not have benefit from the study. Knowledge gained through this study may 
aid the development of more effective treatments for individuals with alcohol dependence and other 
addictive disorders. There are also potential direct benefits to participants in this study. All 
individuals (whether assigned to the active treatment with gemfibrozil or placebo group) are 
receiving treatment (i.e., four sessions of motivational interviewing), and will also be offered a 
referral list upon completion of the study. If the medication being tested works, then individuals 
assigned to the intervention group may also benefit from the treatment. Also, being in a research 
study may provide benefit, as may taking a placebo pill; individuals who undergo a series of 
assessments in a research study oftentimes reduce their drinking even if they are not on active 
treatment. Other aspects of study participation that may be beneficial include receiving free medical 
and psychiatric evaluations, and the attention and support of participating in a clinical trial. 
 
19) 
Vulnerable Populations 
No vulnerable populations will be recruited for this study.   
20) 
Community-Based Participatory Research/Field Research 
N/A 
21) Sharing of Results with Subjects/Incidental Findings 
All research MRI scans are read for incidental findings by a radiologist unless the individual has 
been scanned at MRN in the previous six months. If the scan is read, an e-mail notification is sent 
to the participant letting them know new results are available. The participant can securely log in 
to the COINS Homepage to access their MRI radiology report. No sensitive or identifying 


14 
 
information is sent via e-mail. If an abnormality that requires follow-up is identified, such as a 
Doctor Referral recommendation, a hard copy of the report may be mailed to the participant in 
addition to the e-mail notification. In these cases, the MRN Medical Director may also attempt to 
contact the participant by phone to explain the information and help answer questions. 
 
22) 
Research Setting 
All study procedures and participant interactions will take place at the Mind Research 
Network.  Study medication will be stored in a locked cabinet in a locked room once 
dispensed from the pharmacy.  Blood samples will be processed at Tricore. 
23) 
Resources Available 
The PI and study team are all experienced neuroimaging researchers. John Phillips serves as 
MRN Medical Director. Located on UNM’s north campus, MRN is a 501(c)3 non-profit 
organization consisting of an interdisciplinary association of scientists focused on state-of-the-art 
imaging technology and its emergence as an integral element of neuroscience investigation.  
Five private, closed door rooms are available to research staff for study visits at MRN. These 
assessment rooms have white noise generators outside of the doors to prevent conversations from 
being overheard. These are reserved by investigators as needed, and are easily accessible.  The 
imaging facilities also have private changing rooms with lockers for personal items. In addition, 
there is a space for conducting blood draws that provides privacy to participants while they 
complete the blood draw.  All MRN research staff are trained in regards to the HIPAA Privacy 
Rule. All individuals will be trained to administer the same consenting and study procedures. 
Further, all study personnel will have current CITI and HIPAA training throughout the period of 
the study. 
24) 
Prior Approvals/Attachments Requiring Signatures 
MRN Departmental Review 
25) 
Recruitment Methods  
1.1 
Describe when, where, and how potential subjects will be recruited. 
Participants may be recruited through flyers, radio/TV ads, press releases, newspaper ads, 
business cards, and online postings (e.g. Craigslist, Google Adwords, Facebook, 
Instagram, clinicaltrials.gov) within the Albuquerque metro area. Approved study 
recruitment text and flyers will be used in digital recruitment mediums, such as university 
list-servs, online advertising mediums, or digital presentation slides. The study may also 
recruit using approved text/images on stickers that can be placed on paper bags and 
distributed at liquor stores, and study logos/information placed on bottle openers, drink 
koozies, and other drinking-related paraphernalia which can be handed out during local 
festivals (e.g. brewfests, wine festivals, state fairs, etc).  Word of mouth from current and 
past participants, employees and collaborators, as well as other individuals will also be 
used and may include sharing approved information and/or recruitment materials. Finally, 
participants from other studies who have expressed an interest in being contacted for 
future studies, including from the MRN Participant Recruitment Registry, may be 
contacted to determine eligibility and interest in this study.   
1.2 
Describe the source of subjects. 
Participants will be volunteers from the community. 
1.3 
Describe the methods that will be used to identify potential subjects. 


15 
 
Potential subjects will be self-selected and must contact the laboratory to express initial 
interest in the study.  Once initial contact is made, research staff will explain the study 
and conduct a brief phone screen interview. Also, participants from other studies who 
have expressed an interest in being contacted for future studies, including from the MRN 
Participant Recruitment Registry, may be contacted to determine eligibility and interest in 
this study. 
1.4 
Describe materials that will be used to recruit subjects. (Attach copies of these 
documents with the application. For advertisements, attach the final copy of 
printed advertisements. When advertisements are taped for broadcast, attach the 
final audio/video tape. You may submit the wording of the advertisement prior to 
taping to preclude re-taping because of inappropriate wording, provided the IRB 
reviews the final audio/video tape.) 
Recruitment materials are included with the application (attachments are listed below).  
Brief_advertisement_v031118.docx 
Flyer_v1.docx 
Flyer_v2.docx 
 
 
26) 
Local Number of Subjects 
We anticipate phone screening up to 100 individuals and may enroll up to 50 participants 
in order to obtain a final sample size of 20 participants who complete the study. 
 
27) 
Confidentiality 
All participants are assigned a study ID (URSI) that links their data with their name and other 
identifying information. All study data (with the exception of the consent form and payment 
receipt) are coded only with this number. The information is maintained in a secure, restricted 
access database. After completion of data analysis, the linking code will be made inaccessible to 
the research team. De-identified data will be retained until data analysis activities are complete.  
28) 
Provisions to Protect the Privacy of Subjects 
Five private, closed door rooms are available to research staff for study visits at MRN. These 
assessment rooms have white noise generators outside of the doors to prevent conversations from 
being overheard. These are reserved by investigators as needed, and are easily accessible. The 
imaging facilities also have private changing rooms with lockers for personal items. 
29)  Compensation for Research-Related Injury 
No commitment is made by the MRN to provide free medical care or money for injuries to 
participants in this study. This is clearly stated in the consent form.  
 
30) 
Economic Burden to Subjects 
Participants will not be charged for any of the experimental study procedures, including MRI 
scans. If incidental findings from the study result in the need for further evaluation/treatment, the 
participant or their insurance company will be responsible for additional clinical 
evaluation/treatment that may be needed. Also, incidental finding information is disclosed only to 
the individual participant. However, if a participant chooses to disclose such information also to 
their personal physician, this may become part of their medical record which may or may not 
have an effect in the future on getting health or life insurance.  


16 
 
31) 
Consent Process  
 
Upon initial contact, the study will be briefly introduced to the participant by a member of the 
research team. Participants will then be screened over the phone or in person. Identifiable 
information will be retained for those participants who do not meet inclusion criteria only for the 
duration of the study to ensure that the same participant does not attempt to enroll a second time. 
If the participant meets inclusion criteria, the study visit will be scheduled and an informational 
brochure and copy of the consent document will be sent to them if requested. Participants 
requesting the consent ahead of their visit will be allowed as much time as they need to decide 
whether or not to participate, and the PI or study staff will be available to answer questions about 
the consent/study procedures while the participant is making their decision.   When the 
participant arrives for their appointment, the participant will be seated in a private room and given 
time to read the consent form. After the participant has finished reading the consent form, the 
study is described more fully by the research team and the participant is asked whether they have 
any questions regarding the described procedures and risks/benefits.  Participants must elect to 
participate and can choose to discontinue their participation in the study at any time.  If requested, 
we will show the participants the equipment that will be used to perform the study. In addition, 
we may ask some basic questions of the participants about the proposed study to ensure that the 
participants understand the nature of the experiment.  No coercion or undue influence will be 
used.   
If there are no further questions, the consent form is signed and stored in a locked cabinet in a 
locked office at MRN. A copy of the consent will be given to the participant. 
 
32) 
Drugs or Devices 
All medications will be stored and handled by the research pharmacy and only staff trained to 
dispense medications including the research coordinator or study physicians will dispense 
medications. Medications will be dispensed at Visits 3 and 5, and pill counts/medication 
adherence will be measured at Visits 4-6.  In addition, participants will be asked to report on 
adherence on the follow-up phone call.   
 
 
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ICF_003.pdf: 
1 
 
 
 
Cover Page 
 
 
 
 
 
 
 
Title: Exploration of Gemfibrozil as a Treatment for AUD 
 
Clinical Trial Number: NCT03539432 
 
Consent Document Date: 6/29/2018


 
 
 
 
Page 1 of 8 
 
MIND RESEARCH NETWORK 
CONSENT TO PARTICIPATE IN RESEARCH 
 
Exploration of gemfibrozil as a treatment for AUD 
6/29/18 
 
Purpose and General Information 
You are being asked to participate in a research study that is being done by Eric Claus, Ph.D., who is the 
Principal Investigator, and his co-investigator Claire Wilcox, M.D.  This research is being done to 
evaluate whether the medication gemfibrozil is an effective treatment for alcohol use disorder.  This 
medication is approved by the Federal Drug Administration (FDA) for the treatment of hyperlipidemia 
(which is a condition where individuals have a high concentration of fats or lipids in their blood). Some 
early research in animal studies has shown this medication may help reduce drinking, but use for the 
treatment of alcohol use disorders is considered experimental, and this medication is not FDA approved 
for the treatment of alcohol use disorders. Therefore, the goal of this study is to see if it helps people with 
alcohol use disorder decrease or stop their alcohol use. This study also will try to identify, using 
questionnaires, cognitive testing, and brain imaging [functional magnetic resonance imaging (MRI)] 
which people are most likely to respond to this medication, and how this medication works.  
 
You are being asked to participate because you are interested in reducing or stopping your drinking. 
Approximately 20 people will take part in this study.  The study will take place at the Mind Research 
Network.  This pilot study is funded through support provided by the Mind Research Network. 
 
This form will explain the study to you, including the possible risks as well as the possible benefits of 
participating.  This is so you can make an informed choice about whether or not to participate in this 
study.   Please read this consent form carefully. Ask the investigators or study staff to explain any words or 
information that you do not clearly understand.  
 
What will happen if I participate?  
If you agree to be in this study, you will be asked to read and sign this consent form. After you sign the 
consent form, the following things will happen:   
 
You will first undergo a consenting process which involves reading through this form, and discussing any 
questions you may have with the research staff. You will then answer a series of questions about your 
drinking and psychiatric history, and also complete other questions (e.g. handedness, metal in the body) to 
determine if you qualify for the study.  Females will also complete a urine pregnancy test.  In addition, a 
medical screening will take place in which a medical doctor will conduct a medical history and physical 
examination, and trained research staff will conduct a blood draw. 
 
If you are eligible for the study, you will then be randomized to one of two groups: an active treatment 
group or a placebo group (a placebo is a pill that looks like the active medication, but has no active 
medication in it). Randomization means you will be assigned to a treatment based on chance, like a flip of 
a coin. Neither you nor any member of the research team chooses your assigned group or will know what 
group you are assigned to, however, in an emergency (e.g., if you are hospitalized or in an accident and 
knowing the drug would be important for your treatment), the study doctor can get this information. You 
will have an equal chance of being in either group.  


 
 
 
 
Page 2 of 8 
 
Participation in the study will take a total of approximately 15.5 face-to-face hours and an additional half 
hour over the phone, which will occur over about 7 weeks. The study schedule is as follows: 
x 
Two screening visits: consent visit (2 hours) and physical exam visit (2 hours). 
x 
A baseline visit (visit 3, 4.5 hours): to complete questionnaires, MRI scanning, short talk therapy 
session and medication dispensed (active or placebo).   
x 
Talk therapy (visit 4):  One 45 minute session, one week after starting the medication 
x 
Follow up visit (visit 5, 3.5 hours):  Two weeks after taking medication - questionnaires, MRI 
scanning, blood draw, urine drug test and pregnancy test (females only), brief talk therapy session, 
and additional two weeks of medication.  Trained research staff will conduct the blood draw.  
x 
Follow up visit (visit 6, 2.5 hours):  Four weeks after taking medication - questionnaires, blood draw, 
and the final talk therapy session.  Trained research staff will conduct the blood draw. 
x 
Phone call:  Six weeks after taking medication, we will contact you to do a brief, 30 minute 
interview. 
 
You will be provided the medication/placebo for a total of four weeks.  
 
We have organized the different components of the study below into three categories (Screening, 
Treatment and Assessment), which we will describe in more detail below. 
 
I. Study Eligibility Screening 
As part of screening to see if you qualify for the study, we will ask you about your alcohol and drug use 
in the previous 90 days, conduct a structured interview asking you about psychiatric symptoms and 
substance use history, ask questions about which hand you use to do various tasks, and ask you questions 
to determine whether it is safe for you to go in the MRI.  If you are eligible, you may be asked to return 
for a physical exam and so that we can obtain your medical history. In addition, about 2 teaspoons of 
blood will be drawn with a needle from a vein in your arm and will be checked for kidney function, 
electrolytes, liver function, and blood cell counts; this initial blood draw will occur at the first or second 
visit. You will be informed of the results of the laboratory tests. If you request, we will also call your 
doctor about any abnormal blood work results after you sign a release of information. The study physician 
will review some of your questionnaire results, medical history, and drug and alcohol use history with 
you, and is always available to answer any questions you may have.  
 
At Visits 1, 3, and 5, you will have a breath alcohol test and a urine screen to test for illegal drugs and 
pregnancy (in females of child bearing potential).  At all visits, you will be asked about alcohol use, drug 
use, and alcohol craving.  
 
II. Treatment 
Pending your lab results, if you are enrolled in the study, the study physician will explain the study 
medication in detail to you, including dosing and possible side effects, and will discuss ways for you to 
remember to take your medication. At Visit 3, you will start either the treatment medication or the 
placebo medication.  You will have your medication dispensed to you at Visit 3 and Visit 5.   
At the visits we will review side effects and any adverse events with you, check your blood pressure and 
heart rate, and depending on necessity, may have some other physical exam tests done. In addition to the 
medication, you will also be able to complete 4 sessions of counseling (i.e. talk therapy), which is a 
widely utilized treatment known to help people cut down or stop drinking. At the end of the study, we 
will also offer you a resource list for other potential treatment facilities in the community. 
Participation in this research will include audio taping of your session with the counselor. The 
audio tape will be used for training and quality control purposes and may be coded in the future 


 
 
 
 
Page 3 of 8 
 
to answer research questions. The tapes will only be identified by your subject number.  
Individuals who will have access to these tapes will be the principal investigator and the study 
counselors.   
 
 
III. Assessments 
At some visits, you will be asked to fill out questionnaires which will ask about mood and anxiety 
symptoms and alcohol craving, and you will be asked to perform some cognitive tests on the computer 
and using paper and pencil. You will also complete brain MRI scans during two of the study visits. 
During the MRI scan you will be asked to perform a few tasks, including looking at alcohol-related 
images and/or unpleasant pictures. You may refuse to answer any questions or perform any test that you 
do not wish to answer or do. 
 
Finally, you will be asked more questions about alcohol and drug use over the phone at the end of the 
study.  
 
If you arrive at a study visit intoxicated, the visit will be cancelled, and you will not receive your 
medication refill until you are under the legal limit. Furthermore, you will not be allowed to drive home 
until you are under the legal limit for alcohol. In cases of intoxication, the assessment will be rescheduled 
to occur as quickly as possible. You may be discontinued from the study at any time if you miss study 
visits or scheduled medication doses.  
 
MRI: During the study you will undergo a brain study called an MRI; you will do this procedure twice 
(Visit 3 and Visit 5). To undergo the MRI sessions, we will ask that you abstain from alcohol and all 
illicit drugs for at least 24 hours beforehand, that you not be in alcohol withdrawal, and that you 
remember to take your medication dose that morning. If the MRI results are unclear, you may be asked to 
have an additional MRI done.  For this study, you will lie down on a table and will then be placed into a 
long donut-shaped magnet.  During the study you will hear loud rapping and knocking noises coming 
from the magnet.  You may feel warm during this procedure.  In order to obtain good pictures, it is 
important that you do not move during the procedure.  Although you should not talk during the MRI 
procedure, you will be able to talk with the technician during breaks or in case of emergency by pressing 
a call button or similar device.  During the scan, you may be shown pictures and words and will be asked 
to make decisions about the information presented in them.  This takes about 1 hour to complete.  
 
The MRI scan is being done to answer research questions, not to examine your brain for medical reasons. 
This MRI scan is not a substitute for a clinical scan (the type a doctor would order).  The research scan 
might not show problems that may be picked up by a clinical MRI scan.  However, all research MRI 
scans will be read by a neuroradiologist (a doctor with experience reading MRI scans) unless you have 
been scanned at MRN in the previous six months. When your scan is read, you will receive an e-mail 
letting you know you can download your MRI report from the Participant Portal Homepage.  If we find 
an abnormality that requires follow-up, we may also mail a copy of the report to you, or contact you and 
your doctor (with your permission) by phone to help answer questions. Our Medical Director or the 
research team is always available to answer any questions you may have about your scan. 
 
Urine sample:  You will be asked to provide a urine sample to test for the presence of several drugs, 
including cocaine, heroin, methamphetamine, and marijuana. You will be able to collect the sample in a 
bathroom without anyone watching you.  The results of these tests will not be shared with police, 
security, parole officers, or anyone outside the study team, even if you test positive for a drug.   If you are 


 
 
 
 
Page 4 of 8 
 
a female, we will also test for pregnancy using your urine sample.  Urine drug/pregnancy tests will take 
place at Visits 1, 3 and 5. 
  
 
What are the possible risks or discomforts of being in this study? 
 
Medication:  There are certain risks associated with taking the study medication.  These include: 
Not serious, common (>1%) 
x 
stomach upset 
x 
stomach/abdominal pain 
x 
nausea 
x 
vomiting 
x 
diarrhea 
x 
fatigue 
x 
rash 
x 
dizziness 
x 
 
Serious, uncommon or rare (<1%) 
x 
anemia (decreases in red blood cell counts), leukopenia (decreases in white blood cell counts), 
thrombocytopenia (decreases in platelet counts) 
x 
appendicitis 
x 
persistent nausea or vomiting 
x 
yellowing eyes or skin 
x 
dark urine 
x 
gallstones 
x 
liver problems 
x 
rhabdomyelisis (muscle inflammation, breakdown) 
x 
atrial fibrillation (irregular heart rhythm) 
 
We will check for side effects at every visit and the study physician may choose to discontinue the 
medication if you are showing signs of serious side effects. 
 
MRI:  Radio and magnetic waves associated with MRI scans are not associated with any known adverse 
effects.  MRI is non-invasive and considered minimal risk by the FDA.  However, the scanner is a large 
magnet, so it could move objects with iron in them in the room during the scan. This means that loose 
metal objects, like coin currency or key chains, are not allowed in the MRI room. If you have a piece of 
metal in your body such as a pacemaker, nerve stimulator, piercings or certain metal surgical implants, 
you will not be allowed into the MRI room and cannot have an MRI.  While in the scanner, you may be 
bothered by feelings of claustrophobia (fear of small spaces). If you feel uncomfortable (nervous or upset 
stomach) in the MRI scanner for any reason, tell the research staff.  The MRI also makes loud ‘drum’ 
beating noises during the study.  Headphones will be provided for your safety and comfort.  There is a 
speaker in the MRI scan room as well as a window that allows the operator to view you during data 
collection. This allows the assistants to hear and see you at all times to ensure that you are comfortable 
and to allow them to respond if you are uncomfortable.  You can stop the scan at any time.   
 
No long-term harmful effects from MRI are known. However, since the effect of MRI on early 
development of the fetus is unknown, participants who are pregnant should not go in the MRI.  If you are 
a woman you will be asked to take a urine pregnancy test before being allowed to participate in the study. 


 
 
 
 
Page 5 of 8 
 
You are the only person who will get the results; we will not report the results of the pregnancy test to 
anyone else. Rarely, large tattoos can heat up during an MRI scan and cause skin irritation like a sunburn, 
so the MRI technologist will want to see any tattoos you have prior to the scan.     
 
Due to the very high sensitivity of MRI in detecting abnormalities, there is a risk of false-positive 
findings, identifying something on imaging studies that may or may not be important.  This may result in 
anxiety and additional testing, possibly including a recommendation for clinical scans at your cost.  The 
radiology report or other study data will not be put into your medical record unless you provide it to your 
physician.  If the radiology report becomes part of your personal medical record, it may or may not have 
an effect on getting health insurance or life insurance in the future. 
 
Participation in this study may produce emotional stress, inconvenience or an invasion of privacy. In 
addition, there may also be side effects or risks to study participation that are unexpected and not known 
at this time. Every effort will be made to protect the information you give us. However, there is a small 
risk of loss of confidentiality that may result in stigmatization. Procedures we will use to protect the 
information you give us are described below. 
 
How will my information be kept confidential? 
We will take measures to protect your privacy and the security of all your personal information. Your 
name and other identifying information will be maintained in locked files and/or restricted databases, 
available only to authorized members of the research team for the duration of the study.  All of the 
information we collect about you will be coded with a unique research subject identifier (URSI) or other 
subject code and will be kept on password protected computers according to MRN information security 
policies.  The record linking your name to your study ID number will be kept indefinitely (forever) at the 
MRN in a confidential manner so that you may continue to have access to your information. De-identified 
data (meaning data that cannot be traced back to you) from this study may also be presented at meetings, 
published in journals/books, used in classrooms for training/teaching purposes, and may be shared with 
other researchers, which includes scientists at other universities and institutions. However, your name and 
other identifying information will not be used in any published reports about this study. 
 
To help us protect your information, this research study has applied for a Certificate of Confidentiality 
from the National Institutes of Health (NIH). With this Certificate, the research team cannot be forced to 
provide your name or any identifiable research data or specimens to people who are not connected with 
this study, including Federal, state or local authorities, even under a subpoena. The protection offered by 
the certificate does not stop us from reporting information about suspected or known sexual, physical, or 
other abuse of a child or older person, or that you plan to harm yourself or someone else. If any member 
of the research team is given such information, we will make a report to the appropriate authorities. 
Information from your participation in this study may be reviewed by MRN, federal and state regulatory 
agencies, and by the University of New Mexico Institutional Review Board (IRB) which provides 
regulatory and ethical oversight of human research. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will include 
a summary of the results. You can search this Web site at any time. 
 
What are the benefits to being in this study? 
You may or may not have benefit from the study. Knowledge gained through this study may aid the 
development of more effective treatments for individuals with alcohol dependence and other addictive 


 
 
 
 
Page 6 of 8 
 
disorders. There are also potential direct benefits to participants in this study. Everyone (whether assigned 
to the active treatment with gemfibrozil or placebo group) will receive treatment throughout the study 
with an evidence-based psychosocial intervention provided by the study team, and will also be offered a 
referral list upon completion of the study. If the medication being tested works, then individuals assigned 
to the intervention group may also benefit from the treatment. Also, being in a research study may 
provide benefit, as may taking a placebo pill; individuals who undergo a series of assessments in a 
research study oftentimes reduce their drinking even if they are not on active treatment. 
 
In the course of this research, brain scans will be performed on you.  These scans will be used solely for 
the purpose of gathering scientific information for this study.  During the study, you will not be provided 
a medical diagnosis or treatment for any brain condition, or other health problem.  
Finally, your participation may help find out if gemfibrozil is an effective treatment for alcohol use 
disorder, and, if it is helpful, the mechanism by which it is working.   
 
What other choices do I have if I don’t participate? 
Taking part in this study is voluntary so you can choose not to participate. We will still provide a list of 
treatment providers if you decide not to participate. 
 
New information that may impact your decision to participate 
You will be informed of any significant new findings that become available during the course of 
the study, such as changes in the risks or benefits resulting from participating in the research or 
new alternatives to participation that might change your mind about participating. If any new 
information related to the medication used in the study becomes available, study staff will inform 
you of the new information and you will be able to discuss this information with the PI or study 
physician to determine whether it changes your decision to participate. 
 
Are there any costs to me for participating? 
You will not be charged for any of the experimental study procedures, including the MRI scan. If 
incidental findings from the study result in the need for further evaluation/treatment, then you or your 
insurance company will be responsible for any clinical evaluation/treatment that may be needed. 
 
Will I be paid for taking part in this study? 
In return for your time and the inconvenience of participating in this study you will be paid up to $250 
total for participation via gift cards or cash. The payments will be allocated as follows: consent and screen 
visit $20, history, physical and screen visit $20, baseline assessment (visit 3) $60, counseling session 
(visit 4) $10, second assessment/counseling (visit 5) $80, third assessment/counseling (visit 6) $50, final 
phone assessment $10.   
 
If MRN and/or the investigators develop intellectual property and/or commercialize products or services, 
directly or indirectly, based on the results of the research done with your data, there are no plans to 
provide you with any financial compensation. 
 
Compensation for participation in research is considered taxable income and should be reported on your 
income tax return.  If you earn $600 or more participating in MRN research studies, you will be sent a W-
9 form to collect your tax information which will be reported to the Internal Revenue Service (IRS) as 
required by law.  The information provided to the IRS will not disclose your participation in a research 
study; instead the income will be listed as “nonemployee compensation.”  


 
 
 
 
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Can I stop being in the study once I begin? 
Yes. You can withdraw from this study at any time without affecting your access to care, education, or 
other services to which you are entitled. If you decide you would like to stop the study medication during 
the study, please let your study doctor know as soon as possible and we will help you discontinue it. 
 
The investigators have the right to end your participation in this study if they determine that you no 
longer qualify to take part, if you do not follow study procedures, or if it is in your best interest or the 
study’s best interest to stop your participation.  MRN may stop the study at any time. 
 
What will happen if I am injured or become sick because I took part in this study? 
If you are injured or become sick as a result of this study, the University of New Mexico Health Sciences 
Center (UNMHSC) will provide you with emergency treatment, at your cost.  No commitment is made by 
the MRN or UNMHSC to provide free medical care or money for injuries to participants in this study.   
 
It is important for you to tell the Principal Investigator immediately if you have been injured or become 
sick because of taking part in this study.   
 
Refusal to Sign 
If you choose not to sign this consent form, you will not be allowed to take part in the research study. 
 
What if I have questions or complaints about this study? 
If you have any questions, concerns or complaints at any time about the research study, Eric Claus, Ph.D., 
or his associates will be glad to answer them at 505-272-5028. If you would like to speak with someone 
other than the research team to obtain information or offer input, or if you have questions regarding your 
rights as a research participant, please contact the IRB.  The IRB is a group of people from UNM and the 
community who provide independent oversight of safety and ethical issues related to research involving 
people: UNM Office of the IRB, (505) 277-2644, irbmaincampus@unm.edu. Website: http://irb.unm.edu/  
 
Consent  
You are making a decision whether to participate in this study. Your signature below indicates that you 
read the information provided (or the information was read to you). By signing this consent form, you are 
not waiving any of your legal rights as a research participant. 
__________________________________________________________________________________ 
OPTIONAL: 
We would also like to request your permission to store all of the data that was collected in this study in 
The Mind Research Network Data Sharing Repository for other, future research. The stored data will 
include information such as your age and gender, as well as assessment and imaging data that were 
collected about you during the course of this study. It is possible that this information may remain linked 
to your name. It will be handled with the same care and confidentially as it is for the current study. 
Research done with information from the data repository could lead to improved diagnostic and treatment 
interventions for illnesses and brain disorders. If published, results will be presented in summary form 
only and will not include your name or other identifying information. If MRN develops intellectual 
property and/or commercialize products or services, directly or indirectly, based on the results of the 
research done with your data, there are no plans to provide you with any financial compensation.  
 


 
 
 
 
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You have my permission to store my data in the MRN Data Sharing Repository for future research. Please 
initial next to your choice below.    
YES 
 
________ Initials 
NO 
 
________ Initials 
 
We would like to request your permission to contact you for participation in future studies at the Mind 
Research Network.  If you agree, your contact information may be shared with other scientists at MRN.  
 
You have my permission to contact me about participation in future research studies. Please initial next to 
your choice below.   
YES 
 
________ Initials 
NO 
 
________ Initials 
  
I have had an opportunity to ask questions and all questions have been answered to my satisfaction. By 
signing this consent form, I agree to participate in this study. A copy of this consent form will be provided 
to me. 
_____________________________                    __________________________/_______ 
Name of Adult Participant (print)  
   
Signature of Adult Participant     Date 
 
I have explained the research to the participant and answered all of his/her questions. I believe that he/she 
understands the information in this consent form and freely agrees to participate.  
 
______________________________                     ______________________________/ _____ 
Name of Research Team Member                           Signature of Research Team Member/Date