Clinical trial NCT04019093
Conditions: Temporomandibular Joint Disorders
Keywords: alcohol effects
Sponsor: University of Florida
Start date: 2019-11-05; Completion date: 2022-04-30
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Self-medication of pain with alcohol is a common, yet risky, behavior among individuals with chronic orofacial pain. Chronic pain status may affect the degree to which alcohol use relieves pain, but the independent contributions of pain chronification and alcohol-related expectations and conditioning have not been previously studied. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.

Detailed description:

Arms: arm 1: Individuals seeking care for jaw pain, including temporomandibular joint and muscle disorder (TMD). arm 2: Healthy social drinkers without jaw pain recruited as a comparison group.
Interventions: intervention 1: Ethanol intervention 2: Placebo
Intervention descriptions: intervention 1: A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL. intervention 2: A beverage that does not meaningfully increase breath alcohol concentration.

Protocol documents:
Prot_SAP_000.pdf: 
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Official Title: Acute Effects of Alcohol Use on Chronic Orofacial Pain 
 
NCT: 04019093 
 
Version Date: 7/2/2021 
 
 


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Protocol 
1. Project Title:  
 
Acute Effects of Alcohol Use on Chronic Orofacial Pain 
 
2. Investigator(s):   
 
Jeff Boissoneault, PhD (PI) 
Michael Robinson, PhD (Co-I) 
John Neubert, DDS, PhD (Co-I) 
 
3. Abstract:  
 
It has long been suggested that alcohol has analgesic properties. Data suggest that 
about 25% of chronic orofacial pain patients endorse the use of alcohol for pain 
management. However, the biopsychosocial mechanisms underlying this intuitive 
interaction are not well established. Studies of healthy individuals using quantitative 
sensory testing (QST) have shown that familial risk for alcoholism, as well as 
psychological characteristics like mood and personality, may act as critical factors 
modulating individuals’ sensitivity to alcohol analgesia. However, to our knowledge, the 
acute pain-relieving effect of alcohol intake in individuals with chronic pain has never 
been systematically studied. This relationship is important to understand because 
alcohol analgesia may be associated with relief. Relief from pain may act as a potent 
negative reinforcer for alcohol intake, which, in turn, can have adverse health effects by 
increasing risk of developing an alcohol use disorder in people with chronic pain. Self-
medication of pain with alcohol may also result in harmful drug interactions, risk of injury 
due to neurobehavioral impairment, and even development of painful alcohol 
neuropathy. The overall goal of this proposal is to test the analgesic effects of acute 
alcohol consumption in individuals with chronic pain and a comparison group of pain-
free controls, and identify critical biopsychosocial modulators of alcohol analgesia. 
These efforts will inform research and clinical/translational efforts regarding modifiable 
and unmodifiable factors related to risk associated with self-medication of chronic pain 
using alcohol, and provide critical feasibility and effect size data for future proposals. 
 
4.   Background: 
 
Introduction. While acute pain is an essential indicator of current or impending tissue 
damage, chronic pain is a maladaptive state with strong affective, biological, and 
psychological components. Chronic pain has strong negative effects on quality of life for 
the nearly 100 million American sufferers and is extremely costly, with associated 
expenditures reaching $635B per year in the United States alone (Institute of Medicine, 
2011). Existing treatments for chronic pain, including opioid analgesics, are relatively 
ineffective, (Noble et al., 2010) rarely meet patients’ own criteria for successful 
treatment (Robinson et al., 2005), and are associated with significant risk (i.e., the 
opioid epidemic; Volkow and Collins, 2017). Therefore, it is intuitive that patients may 
seek alternative and potentially maladaptive methods for pain relief. Nearly 25% of 


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individuals suffering from chronic orofacial pain endorse self-medicating their pain with 
alcohol (Riley and King, 2009). Alcohol interacts directly or indirectly with many 
neurotransmitter systems, including the serotonergic, glutamatergic, and opioidergic 
systems, providing a wide range of relevant pharmacologic targets that may affect pain 
sensation (Vengeliene et al., 2008). This behavior is concerning because harmful 
interactions may occur between alcohol and pain medications, self-medicating patients 
likely exceed moderate drinking guidelines, increasing risk of alcohol-related 
consequences, and alcohol withdrawal is associated with increased pain sensitivity 
(NIAAA, 2013). The health-related consequences of alcohol use and misuse are 
estimated at over $200B per year (Spanagel, 2009). Given that 25% of treatment 
seeking alcoholics report past-month pain, and 25% of chronic pain patients report 
heavy drinking (Zale et al., 2015), it is likely the adverse effects of self-medicating pain 
with alcohol are responsible for part of the cost associated with both conditions.  
 
Mechanisms of Pain. Acute pain is a centrally mediated sensation driven by nociceptive 
input conducted by Aδ and C fibers responding to noxious stimulation or tissue injury in 
the periphery. An individual’s experience of pain is modulated by the activity of a well-
characterized set of neural structures involved in the contextualization and evaluation of 
the nociceptive stimulus, including those involved in sensory, limbic, and executive 
functions (Apkarian et al., 2005; Clarke and Lawrence, 2013; Craggs et al., 2007; Staud 
et al., 2008). In a minority of cases (~10-20%), pain persists even after the peripheral 
healing process is complete. The transition from acute to chronic pain is thought to be 
reflected by central sensitization (i.e., a generalized increase in pain associated with 
nociceptive input). Central sensitization is underpinned by marked change at multiple 
levels, including epigenetic modification of nociceptor-related genes (Bai et al., 2014), 
modulation of dorsal horn n-methyl d-aspartate receptors (NMDARs; Woolf and Salter, 
2000), aberrations in functional measures of brain activity during pain (Hashmi et al., 
2013), and psychological factors including anxiety, depression, fear, and catastrophizing 
(Williams, 2013). Therefore, it is likely that biopsychosocial mechanisms underlying 
alcohol analgesia as well at its efficacy may differ between individuals in acute pain vs. 
those with chronic pain conditions.  
 
Pain is, by definition, aversive (International Association for the Study of Pain, 1979). 
Therefore, the cessation of pain is associated with relief. Although conceptually distinct 
from typical appetitive rewards like palatable food or drugs of abuse, substantial 
similarity between neurobehavioral responses to relief and appetitive rewards has been 
reported (Leknes et al., 2011; Seymour et al., 2005; Tanimoto et al., 2004; Ursu and 
Carter, 2005). Indeed, appetitive rewards are more reinforcing when simultaneously 
providing relief (Cabenac, 1979; Leknes et al., 2011). This is likely due to a 
synergistic combination of positive and negative reinforcement, suggesting self-
medication of pain using alcohol may represent a “double-hit” of reinforcement, 
increasing risk of developing an alcohol use disorder.  
 
Acute Alcohol Effects. Acute alcohol intake at legally intoxicating levels (i.e., BAC ≥ 0.08 
g/dL) is associated with robust decrements in inhibitory control (Dougherty et al., 2008; 
Fillmore and Weafer, 2004; Loeber and Duka, 2009), psychomotor performance 
(Harrison and Fillmore, 2005), attentional function (Marczinski and Fillmore, 2006), and 


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working memory processes (Soderlund et al., 2005; Weissenborn and Duka, 2000). 
Even subintoxicating blood alcohol concentrations (BACs) can selectively disrupt 
neuropsychological processes critical for the processing of nociceptive stimuli, including 
sustained and/or divided attention, inhibitory control, and working memory (Boissoneault 
et al., 2014; Boissoneault et al., 2016; Breitmeier et al., 2007; de Wit et al., 2000; 
Friedman et al., 2011; Gilbertson et al., 2009; Holloway, 1994; Lloyd and Rogers, 1997).  
Numerous factors besides dose may modulate the effects of acute alcohol. Critically, 
expectations regarding the positive and negative effects of a given alcohol dose are 
important predictors of its neurobehavioral effects. Numerous studies indicate 
expectation of impairment is an important predictor of behavioral compromise following 
alcohol administration (Field et al., 2008; Fillmore et al., 1998; Marczinski and Fillmore, 
2005) and almost certainly contributes to alcohol’s analgesic effects as well. In addition, 
individuals with a family history of alcoholism (FH+) have atypical subjective responses 
to alcohol, with competing models describing either consistently lower levels of 
response to alcohol challenge, or increased stimulation on the ascending limb combined 
with decreased sedation on the descending limb (Morean and Corbin, 2010; Schuckit, 
1994).  
 
Studies of the neurophysical and functional correlates of alcohol-induced 
neurobehavioral compromise indicate disruption of functional activation and glucose 
utilization in brain structures including anterior cingulate gyrus, prefrontal cortex, medial 
frontal cortex, and the basal ganglia (Anderson et al., 2011; Marinkovic et al., 2012; 
Soderlund, et al., 2005, Volkow et al., 2006). Notably, these areas and the evaluative, 
limbic, and executive networks they form are implicated as modulators of acute and 
chronic pain, suggesting a common neural framework underlying both acute alcohol 
effects and the pain experience (Hashmi et al., 2013).  
 
Alcohol Analgesia. Despite recent interest in the interaction between alcohol use/misuse 
and chronic pain (Apkarian et al., 2013; Egli et al., 2012; Zale et al., 2015) and data 
suggesting self-medication of pain with alcohol is widespread (Brennan et al., 2005; 
Riley and King, 2009), few systematic investigations of alcohol analgesia have been 
conducted. Early studies identified dose-dependent reductions in pain sensitivity from 
alcohol consumption, but major methodological limitations, including lack of placebo 
control and blinding, limit their usefulness (Mullin and Luckhardt, 1934; Wolff et al., 
1941; Wolff et al., 1942; Cutter et al., 1976).  
 
Subsequent studies have improved upon initial efforts using Widmark equations 
(Watson et al., 1981) to target specific BAC levels and by accounting for typical drinking 
pattern and history of alcoholism. Results of a double-blind, placebo controlled study in 
healthy young adults suggested pain relief was partially moderated by typical drinking 
pattern (Brown and Cutter, 1977). In a follow-up study, endorsement of alcohol use to 
increase confidence and reduce stress was associated with greater analgesic response 
(Cutter et al., 1979). Stewart and colleagues (1995) found that a legally intoxicating 
dose of alcohol (peak BAC ~0.09 g/dL) produced a reduction in pain ratings from 
electric shock that was significantly greater in individuals with an alcoholic parent. To 
minimize expectancy effects, several studies of alcohol analgesia using intravenous 
administration have been conducted. These studies lack ecological validity but provide 


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valuable insight into the pharmacological component of alcohol analgesia. James and 
colleagues (1978) found infusion of both 1.5 g/kg and .75 g/kg doses produced 
significant elevation in pressure pain thresholds. Similarly, BAC clamping at 0.10 g/dL 
produced significant increases in pain tolerance in healthy drinkers (Perrino et al., 
2008). Follow-up analyses revealed that FH+ individuals with high neuroticism had a 
significantly greater analgesic response at 0.04 g/dL than FH negative or low 
neuroticism individuals, suggesting personality factors may interact with FH to 
determine analgesic responses to alcohol (Ralevski et al., 2010). 
  
Summary. To our knowledge, the analgesic effect of alcohol intake on clinical pain 
in a chronic pain population has never been studied despite strong 
biopsychosocial links between pain and risky alcohol use. In addition, mechanisms 
and modulating factors underlying alcohol analgesia are poorly understood. Systematic 
study of alcohol analgesia is required to better understand these mechanisms and their 
implications for patient education, screening, care, and management. To maximize 
clinical relevance, we propose the use of a well-controlled, clinically-relevant pain 
induction (i.e., pressure algometry) in a population of patients with temporomandibular 
joint and muscle disorder (TMD) in this study. 
 
5. Specific Aims: 
 
Aim 1. Characterize the acute analgesic effects of alcohol in individuals with 
chronic temporomandibular joint and muscle disorder (TMD). Despite evidence 
that self-medication of pain with alcohol is common among people with TMD (Riley and 
King, 2009), quantitative data regarding the magnitude of this effect is largely lacking. 
Similarly, it is unclear whether the acute analgesic effects of alcohol may differ between 
individuals with and without chronic pain. We believe TMD is an ideal model with which 
to test the acute effects of alcohol intake on clinical pain because it is a relatively 
common condition (~5-12% of the general population; Goulet et al., 1995; Johansson et 
al., 2006), and clinically relevant pain can be reliably evoked in laboratory settings by 
applying pressure at the insertion of the masseter muscle (i.e., pressure algometry; 
Brown et al., 2000). Hypothesis (H)1. We hypothesize that consumption of a dose of 
alcohol sufficient to produce a breath alcohol concentration (BrAC) of ~ .08 g/dL will be 
associated with significant reduction in pain sensitivity compared to placebo in both 
TMD patients and healthy controls, and H2. acute alcohol will be associated with 
greater ratings of perceived relief than placebo following pain induction. Evidence from 
the animal literature suggests chronic pain may modulate the acute effects of opioid 
administration. Furthermore, chronic pain is associated with maladaptive plasticity in 
brain regions that underpin acute alcohol effects, including medial prefrontal cortex and 
nucleus accumbens (for review, see Egli et al., 2012). Thus, although it is likely that 
TMD patients may experience differential effects of alcohol use on pain sensation 
compared to healthy controls, the directionality of this effect is currently unclear. Thus, 
we predict H3. chronic pain status will moderate the magnitude of alcohol analgesia but 
ask as an empirical question (E)1. whether the effect of alcohol on pain sensitivity will 
be stronger or weaker in this group. Attenuated analgesic response in TMD patients 
would be consistent with rat studies suggesting neuropathic pain shifts opioid dose-
response curves, increasing opioid self-administration (Egli et al., 2012). In contrast, an 


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exaggerated analgesic response would suggest alcohol use might be especially 
negatively reinforcing.  
 
Aim 2. Determine the influence of typical alcohol use and expectation of pain 
relief with alcohol use on magnitude of alcohol analgesia and associated feelings 
of relief. Studies of alcohol analgesia in healthy adults have indicated that individual 
patterns of typical alcohol use, motivation to drink, and personality factors may 
modulate alcohol analgesia, suggesting a critical role of conditioning and expectancies 
(Brown and Cutter, 1977; Cutter et al., 1979; Ralevski et al., 2010). However, this 
question has never been directly examined, either in healthy adults or those with 
chronic pain. H4. We predict individuals with stronger positive expectancies regarding 
alcohol analgesia will have significantly stronger analgesic responses to alcohol 
administration. H5. Based on previous research, we predict that individuals who 
endorse greater and more frequent alcohol consumption will experience a greater 
analgesic effect of alcohol, independent of the effect of expectancies. Finally, we ask as 
E2. whether chronic pain status will be associated with stronger expectancies of pain 
relief following alcohol consumption and E3. greater ratings of pain relief during 
pressure algometry after drinking. 
6. Research Plan: 
 
General Approach. For this study of current non-problem drinkers, we propose a 
repeated-measures, double blind placebo-controlled factorial design with chronic pain 
status (TMD vs. healthy control) as a between-subjects factor and alcohol 
administration (Alcohol Dose: placebo, 0.08 g/dL) as a within-subjects factor. The study 
will include both men and women. Study procedures will occur at the Center for Pain 
Research and Behavioral Health of the University of Florida under supervision of the PI 
(JB).  
 
Methods  
 
Participants. Individuals seeking care for temporomandibular joint and muscle disorder 
(TMD) (n=25) will be recruited for the study via flyers, word of mouth, internet/local radio 
advertisements, and Dr. Neubert’s orthodontic clinic. A sample of healthy social drinkers 
without TMD (HC) will also be recruited as a comparison group (n=25). Individuals aged 
21-45 years will be recruited to avoid any vulnerability to acute neurobehavioral effects 
of alcohol associated with older age (e.g., Boissoneault et al., 2016a). Because TMD is 
more prevalent in women than men (~2:1; Campbell et al., 2017), we anticipate the final 
sample will consist of approximately 2/3 women.  
 
Selection Criteria. TMD diagnosis will be confirmed by Dr. John Neubert, a practicing 
orthodontist and orofacial pain expert, or a qualified dentist designated by Dr. Neubert in 
situations where he may not be available, based on published Research Diagnostic 
Criteria (Schiffman et al., 2014). As guided by the Research Diagnostic Criteria for 
TMD, TMD participants in the TMD group must report TMD-related orofacial pain over 
the 6 months preceding screening. Participants will be excluded if they have a history of 
a chronic pain condition other than TMD (e.g., osteo- or rheumatoid arthritis, 
fibromyalgia, complex regional pain syndrome); report use of opioid analgesics; current 


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major depression; history of any psychotic disorder; undercontrolled hypertension or 
diabetes  
 (as reflected by self-
report); neurological 
disease (e.g., multiple 
sclerosis, epilepsy, 
amyotrophic lateral 
sclerosis, Parkinson’s 
disease); serious 
medical illness (e.g, 
hepatitis, HIV/AIDS); 
impaired cognitive 
function; or history of 
drug or alcohol 
dependence. Because 
chronic smoking is 
associated with adverse 
neurobehavioral 
changes (Boissoneault 
et al., 2011; Durazzo et 
al., 2013), participants 
must be non-smokers. 
Participants must also 
be current drinkers (i.e, 
consume at least 1 
drink/month over the last 
6 months). Alcohol 
abstinent or naïve 
individuals will be 
excluded. To avoid 
confounding effects of 
binge-drinking 
patterns, participants 
must score lower than 
an 8 on the AUDIT. To 
increase ecological 
validity and ensure 
feasibility of 
recruitment, use of prescription medications will be allowed provided they do not 
contraindicate alcohol use (Boissoneault et al., 2014; Gilbertson et al., 2009).  
 
Screening Procedure. Interested individuals contacting the Center for Pain Research 
and Behavioral Health via phone or email will be scheduled for a formal screening 
session. Dr. Neubert will also facilitate contact between potential TMD participants he 
encounters as a part of his orofacial pain practice and study staff. During screening, 
information regarding demographics, FH of drug and alcohol use (including nicotine), 
Screening 
Measure  
Domain  
Exclusionary Cutoff  
BDI-II  
Depressive 
Symptomology  
≥ 20 (moderate 
depression)  
STAI  
State/Trait Anxiety  
Not Exclusionary  
AEQ  
Alcohol Expectancies  
Not Exclusionary  
AUQ  
Alcohol Use Pattern  
Not Exclusionary  
AUDIT  
Alcohol Use Disorder 
Sx 
≥ 8 
PILL 
Somatic preoccupation 
/neuroticism  
Not Exclusionary  
FTQ  
FH Assessment  
Not Exclusionary  
PSQI 
Sleep Quality 
Not Exclusionary 
BRS 
Resilience to stressors 
Not Exclusionary 
DIS 
Ability to tolerate 
physical discomfort 
Not Exclusionary 
EAA 
Expectancies regarding 
pain relief from alcohol 
Not Exclusionary 
PCS 
Pain catastrophizing 
Not Exclusionary 
PASS-20 
Pain-related Anxiety 
Not Exclusionary 
IRI 
Empathy 
Not Exclusionary 
OHIP-TMD 
TMD Pain Severity and 
Interference 
Not Exclusionary 
Table 1. Screening Measures. BDI-II: Beck Depression Inventory (Beck et al., 1996); STAI: 
State-Trait Anxiety Inventory (Spielberger, 1983); AEQ: Alcohol Expectancies Questionnaire 
(Brown et al., 1987); AUQ: Alcohol Use Questionnaire (Cahalan et al., 1969); AUDIT: Alcohol 
Use Disorders Identification Test (Saunders et al., 1993); PILL: Pennebaker Inventory of 
Limbic Languidness; FTQ: Family Tree Questionnaire (Mann et al., 1985); PSQI: Pittsburgh 
Sleep Quality Index (Buysse et al., 1989). BRS: Brief Resilience Scale (Smith et al., 2008); 
DIS: Discomfort Intolerance Scale (Schmidt et al., 2006); EAA: Expectancies for Alcohol 
Analgesia Inventory (Ditre et al., 2018); PCS: Pain Catastrophizing Scale (Sullivan et al., 
1995); PASS-20: Pain Anxiety Symptoms Scale (Short Version; McCracken and Dhingra, 
2002); IRI: Interpersonal Reactivity Inventory (Davis, 1980), OHIP-TMD: Oral Health Impact 
Profile for TMDs (Durham et al., 2011). 


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typical drinking behavior, affective and personality, alcohol-related expectancies, and 
medical history will be collected (see Table 1). The PI will facilitate contact with clinical 
services if desired. Subjects endorsing suicidal intent will be withdrawn from the study. 
Dr. Robinson, a licensed clinical psychologist, will provide an appropriate referral. 
Baseline quantitative sensory testing (QST) measures of pain sensitivity and tolerance 
using pressure algometry at the insertion of the masseter muscle (described in detail 
below) will be taken after participants’ eligibility and willingness to continue is confirmed. 
Participants will provide their own transportation to screening sessions. Participants will 
be paid $15 for completing screening, requiring ~1-2 hours.  
 
Laboratory Sessions. Consistent with previous work (Boissoneault, et al., 2014; Lewis, 
et al., 2013), participants will be asked to fast for at least 4 hours prior to their scheduled 
session and abstain from alcohol consumption 24 hours before each of the two 
laboratory sessions. Use of non-steroidal anti-inflammatory drugs (NSAIDs) in the 12 
hours prior to testing will also be restricted. Normal morning medications will be 
permitted, but OTC medications (including allergy medications and analgesics) will not 
be allowed. A urine- based drug screen for tetrahydrocannabinol, cocaine, 
benzodiazepines, morphine, and methamphetamine (Innovacon, Inc., San Diego, 
CA) will be performed. Participants testing positive for any substance will be 
discontinued. A baseline breath alcohol concentration (BrAC) measure will be 
taken, which must be negative. Women will complete a brief questionnaire regarding 
their menstrual cycle, including: 1) if they are currently menstruating or post-
menopausal; 2) typical time between menstruation; 3) days elapsed since last menses; 
4) typical menses length; and 5) use of any hormonal preparations (e.g., birth control). 
Women of child bearing potential will be given a pregnancy test; positive tests 
will result in exclusion from the study with a recommendation to contact her 
physician. Women who are currently breastfeeding will also be discontinued. All testing 
will be conducted in private rooms within the Center for Pain Research and Behavioral 
Health. Participants will be provided with a light breakfast one hour before alcohol 
administration (~200 kcal). Following breakfast, participants will repeat affective 
measures (BDI-II/STAI) as well as an Irritability Questionnaire (IRQ; Craig et al., 2008). 
Lunch will be provided following testing, as well as another light meal as needed. At the 
conclusion of their final laboratory session, individuals in the TMD group will also be 
asked whether and how frequently (never, sometimes, frequently, always) they have 
used alcohol to help control their TMD pain (Riley and King, 2009). For laboratory 
sessions, the PI or a research assistant will schedule a ride with Uber or Lyft to drive 
participants home after the completion of the session. Research assistants will use the GPS 
features of the rideshare app to ensure that participants make it home safely. If the 
rideshare app indicates that the participant was dropped off somewhere other than the 
vicinity of their home, the attending researcher will call the number left by the participant 
and speak with the participant. If the participant does not answer the phone, the researcher 
will contact the IRB to report the protocol deviation. Participants will be paid $50 for 
completing each of the two laboratory sessions. Laboratory sessions will be separated 
by at least 48 hours.  
 
Alcohol Administration. Alcohol administration procedures are consistent with our 
previous work and NIAAA guidelines for the safe and ethical administration of alcohol in 


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experimental settings (Brown et al., 2014). Participants will complete two laboratory 
sessions in which they will be administered one of two beverages: placebo (0.00 g/dL 
target BrAC) or active alcohol (0.08 g/dL target BrAC). Session order will be 
counterbalanced across participants. For laboratory sessions in which a participant will 
be given the active dose, the quantity of medical/United States Pharmacopeia grade 
alcohol (100% or 95% ethanol) needed to achieve 0.08 g/dL (i.e., approximately 3-4 
standard drinks) will be calculated using a modification of the Widmark formula. This 
formula utilizes age and weight measures for men and height and weight measures for 
women (Watson, et al., 1981; Widmark, 1932). For example, a 30-year old man who is 
183 cm tall and weighs 75 kg would receive 55.3 ml of absolute ethanol, or ~.58 g/kg. In 
order to maintain the study’s double blind, a researcher not involved in QST will be 
responsible for calculating alcohol doses and mixing drinks, and the dose calculation 
and mixing procedure confirmed by a second research assistant. Pre-calculated dose 
lookup tables indexing height and weight for women and age and weight for men will be 
used to avoid dosing errors. Alcohol will be mixed with cold sugar- free lemon-lime soda 
in a 1:3 ratio and split into two servings (Boissoneault, et al., 2014; Gilbertson, et al., 
2009; Harrison et al., 2007). Placebo beverages will consist of only soda. Participants 
will consume both servings within 5 minutes. Both active and placebo drinks will be 
misted with alcohol to enhance placebo effectiveness. A small amount of alcohol 
will be placed on the rim of the glass and floated on the surface of the beverage 
to further mask the study condition. Participants will rinse their mouths thoroughly 
with water once their beverage has been consumed. No suggestion regarding the 
potential pain-relieving effects of alcohol will be provided before or after beverage 
administration to avoid influencing expectations. All study staff over the age of 21 
designated as “Interacts or intervenes directly with study subjects” on the myIRB smart 
form will be trained by the PI how to use the lookup tables and mix beverages and may 
serve in this capacity depending on availability for a given laboratory session. 
 
BrAC Assessment. Following beverage administration, breath alcohol concentration 
(BrAC) measures will be obtained every 10 minutes, as well as immediately prior to and 
after QST, using standard a handheld breath analysis device (e.g., Intoxylizer 400PA, 
CMI, Inc., Owensboro, KY). Breath measures will be taken periodically until the 
participant’s BrAC is ≤ 0.02 (Brown et al., 2014). They will then be transported home.  
 
Subjective Intoxication and Placebo Effectiveness. Participants will complete brief visual 
analog scales (VAS) assessing their subjective intoxication (anchored from ‘not at all 
intoxicated’ to ‘most intoxicated imaginable’; Harrison, et al., 2007). These assessments 
will be administered concurrently with BrAC assessments and before/after QST. To 
assess the contribution of subjective stimulatory/depressant effects to alcohol 
analgesia, the Subjective Effects of Alcohol Scale (SEAS; Morean et al., 2013) will be 
administered immediately prior to QST. The SEAS measures both positive and negative 
aspects of stimulation and sedation (i.e., HIGH+/- and LOW+/-). After testing, 
participants will indicate whether they believe they received an alcoholic beverage; 
those who do not believe they received a beverage will be asked when they made that 
determination.  
 


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Pain Induction Procedure. QST testing will occur in a private room within the Center for 
Pain Research and Behavioral Health using an approach developed by our research 
group (Brown et al., 2000). Pain induction will involve application of manual pressure to 
the insertion of the masseter muscle, 1 cm superior and anterior to the angle of the 
mandible. This location will be marked with ink to ensure a consistent stimulation site. 
For participants with TMD, pressure will be applied to the most affected (i.e., sensitive) 
side of the face, as determined during Dr. Neubert’s examination. For control 
participants, the side of the face to be stimulated will be randomly determined. Dr. 
Neubert will train the PI and all research assistants (RAs) to ensure consistent 
localization of this point across participants. Pressure will be increased over a 1s 
duration and maintained for 2s using a Wagner Force One pressure algometer (Wagner 
Instruments, Greenwich, CT). VAS pain intensity and unpleasantness ratings (anchored 
from “no pain at all”/”not at all unpleasant” to “most intense/unpleasant imaginable”) will 
be collected. Ratings will be collected at 4, 5, and 6 foot pounds per square inch (fpsi). 
Pain ratings will also be collected 15 and 30 seconds after algometer removal to assess 
aftersensation. This procedure will be repeated three times, with pressures alternated in 
pseudorandom order. Mean pain ratings at each stimulation level will be used to 
calculate individualized slopes (representing discriminability between pressure stimuli) 
and intercepts (representing response bias) for each participant and treatment condition 
(i.e., active alcohol vs. placebo) (Brown et al., 2000). Pain threshold will also be 
assessed by increasing pressure on the masseter insertion at a rate of .5 fpsi/s. 
Participants will indicate when the sensation first becomes painful and provide a VAS 
rating of pain intensity at the threshold pressure. This procedure will also be repeated 
three times and threshold and pain intensity measures will be calculated as the mean of 
the three trials. Following each QST measure, participants will be provided with a 10 cm 
VAS assessing perceived relief from pain resulting from beverage consumption 
(anchored from “No relief at all” to “Most profound relief imaginable”). QST procedures 
will require approximately 15 minutes. During laboratory sessions, QST procedures will 
begin approximately 15 minutes after beverage consumption to allow for absorption of 
alcohol (Boissoneault et al., 2014).  
 
Data Analysis Strategy. Data will be analyzed using SPSS 24 (IBM Corp., Armonk, NY). 
 
Aim 1. Determine the effect of chronic pain status on magnitude of alcohol 
analgesia and associated feelings of relief. To assess hypotheses and empirical 
questions related to Aim 1, chronic pain status will be included as an independent 
variable in repeated measures general linear models analyses (rmGLM; SPSS GLM 
procedure; repeated: dose), with QST measures, associated relief ratings, and SEAS 
measures as dependent variables. Demographic, personality/affective (i.e., 
BDI/STAI/IRQ/BFI), substance use-related (recent alcohol use/alcohol use disorder 
symptomatology), pain-related (TMD severity), and biological (i.e., approximated 
menstrual phase for female participants) variables will be included as covariates should 
any correlate significantly with magnitude of alcohol analgesia or relief ratings.  
Aim 2. Determine the influence of typical alcohol use, and alcohol analgesia-
related expectancies on magnitude of alcohol analgesia and associated feelings 
of relief. A combination of approaches will be used to address Aim 2. Simultaneous 
multiple regression of alcohol analgesia expectancy and typical alcohol consumption 


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(estimated in ounces of absolute ethanol consumed per day derived from the AUQ) on 
QST measures will be used to evaluate H4 and H5. As in Aim 1, rmGLM will be used to 
assess E2 and E3.  
Power Analysis. Power analyses for the proposed work are based on effect sizes 
derived from our initial feasibility study (see attached grant application for details) and 
were performed assuming two-tailed hypothesis tests with alpha=.05. Effect sizes are 
reported as Cohen’s d, Pearson’s r, or R2 (Cohen, 1988). Analyses indicated N=50 
would provide excellent (98%) power to detect analgesic effects of alcohol 
administration on QST measures (Cohen’s d > .58) and correlations between VAS 
ratings of relief and alcohol analgesia (r = .64). Critically, this sample size will also 
provide 80% power to detect small-to-medium sized effects (d > .40; r > .37; R2 > .14) 
for which prior estimates are not available (e.g., the effect of chronic pain status on 
alcohol analgesia and subject alcohol affects). We will recruit a total of 60 qualified 
subjects over the course of the project to account for 10% anticipated participant 
dropout before completing all study visits.  
 
7.    Possible Discomforts and Risks: 
 
Psychological Discomforts and Risks. Some aspects of the questionnaires utilized in 
this proposal may make study participants uncomfortable, especially those dealing with 
affect or medical history. To ameliorate this possibility, participants will be informed they 
can withdraw from the study at any time or skip individual questions that may be 
upsetting to them.  
 
Acute Alcohol Intake. Alcohol intake may result in dizziness, nausea, and vomiting 
should a participant tolerate the active dose of alcohol poorly. The risk of these as well 
as more serious consequences may increase if a participant uses medications that 
contraindicate the use of alcohol (e.g. benzodiazepines/opioid analgesics). Should a 
participant experience any of these symptoms, they will be allowed to rest until 
symptoms subside and will be allowed to withdrawal from the study if desired. We have 
attempted to minimize this risk by recruiting only those who are regular moderate 
drinkers and excluding those regularly taking prescription medications that 
contraindicate the use of alcohol. Ss will be rescheduled if they report having taken 
prescription or over-the-counter medications that contraindicate alcohol use on the day 
of testing.  
 
Pregnancy: Alcohol intake is an unacceptable risk in pregnancy. Therefore, anyone of 
childbearing potential will be tested for pregnancy on the morning of the laboratory 
session. Positive pregnancy tests will result in exclusion from study and lab staff will 
assist in making a referral as appropriate. Finally, any documents associated with a 
participant testing positive for pregnancy will be destroyed without reference to a 
specific cause.  
 
Breath Analyzer Testing: Breath analyzer testing may result in dizziness or 
lightheadedness for some individuals. However, the PI has administered many of these 
tests and never observed a significant negative consequence. Staff will be trained to 
recognize discomfort resulting from breath analyzer testing and will assist participants in 


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ameliorating symptoms should they occur (eg., discontinue testing, place head between 
knees, etc.).  
 
QST Discomfort and Risks. QST, by definition, will induce pain in participants. However, 
risk of harm as a result of QST procedures is minimal for the following reasons: 1) the 
pain is transient in nature and generally subsides immediately after the procedure; 2) 
participants are instructed that they may stop any procedure at any time with no 
adverse consequences; and 3) although pain sensation may continue after pressure 
algometer removal (at discretion of the participant), this is not expected to last longer 
than 90 seconds. Furthermore, because pressure applied to the masseter will not 
exceed 8 foot pounds per square inch (fpsi) the risk of contusion is very slight. Should a 
participant suffer continued pain 24 hours after pressure algometry, an adverse event 
will be reported to the IRB.  
 
Participant Confidentiality Risks. The investigative team places a high priority on 
protection of patient confidentiality and will use the following procedures to protect 
patients. Unique participant identifiers will be generated in order to collect protected 
health information (i.e., from questionnaires) for research purposes. Paper 
questionnaires and forms will be stored in a locked storage space, digital information 
will be stored in encrypted, password protected files on secure servers, and the data 
that links the participants to their unique identifiers will be stored in a separate location. 
When the study is completed and all raw data is entered electronically, participant 
identifiers will be destroyed. Despite these efforts, it is possible that participant 
confidentiality may be breached. If a breach occurs, it will be reported to NIH and the 
IRB and appropriate measures will be taken. These measures include but are not 
limited to informing affected participants of the breach and assisting with protective 
measures once the breach is detected.  
 
Data and Safety Monitoring Plan  
Because the proposed study does not comprise a clinical trial, a formal Data and Safety 
Monitoring Board has not been planned. The investigative team, including Drs. 
Boissoneault, Robinson, and Neubert, will meet quarterly to discuss data and safety 
monitoring issues. Any issues identified during these meetings will be handled in a 
manner consistent with the policies of the NIH and University of Florida.  
8.    Possible Benefits:  
 
There are no potential benefits to participants in this study. 
 
9.    Conflict of Interest:  
 
There is no conflict of interest involved with this study beyond the professional benefit 
from academic publication or presentation of the results. 
 
 
 
 


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INFORMED CONSENT FORM
to Participate in Research, and
AUTHORIZATION 
to Collect, Use, and Disclose Protected Health Information (PHI)
INTRODUCTION
Name of person seeking your consent:
Place of employment & position: 
Please read this form which describes the study in some detail. A member of the research 
team will describe this study to you and answer all of your questions. Your participation is 
entirely voluntary. If you choose to participate you can change your mind at any time and 
withdraw from the study. You will not be penalized in any way or lose any benefits to which 
you would otherwise be entitled if you choose not to participate in this study or to withdraw. 
We aim to create an environment of mutually respectful interactions between research staff 
and participants. We pledge that research staff will not engage in disrespectful behavior or 
use racist, sexist, or other inappropriate language, and ask the same of you. If you have 
questions about your rights as a research subject, or have concerns regarding the conduct 
of research staff during your participation, please call the University of Florida Institutional 
Review Board (IRB) office at (352) 273-9600.   
GENERAL INFORMATION ABOUT THIS STUDY
1.
Name of Participant ("Study Subject")
___________________________________________________________________ 
2.
What is the Title of this research study?
Acute Effects of Alcohol Use on Chronic Orofacial Pain
3.
Who do you call if you have questions about this research study?
Jeff Boissoneault, PhD, Principal Investigator (352-273-6147)
Michael Robinson, PhD, Co-Investigator (352-273-6617)
John Neubert, DDS, PhD, Co-Investigator (352-273-5687)
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4.  Who is paying for this research study? 
The sponsor of this study is National Institute on Alcohol Abuse and Alcoholism 
(NIAAA).
5.  In general, what do you need to know about this Research Study?
Agreeing to become involved in any research is always voluntary. By signing this 
form, you are not waiving any of your legal rights. If you decide not to participate in 
this research, you will not be penalized in any way and you will not lose any benefits 
to which you are entitled. If you have questions about your rights as a research 
subject, please call the University of Florida Institutional Review Board (IRB) office at 
(352) 273-9600.    
You are being asked to be in this research study because you are a healthy current 
drinker between the ages of 21 and 45 who may or may not have chronic jaw pain, 
including temporomandibular joint and muscle disorder (TMD). You should not be in 
this study if you:

Have a medical history or condition that would conflict with study participation, 
including chronic pain other than jaw pain

Are unable to speak and read English

Are currently participating in another research study that could interfere or 
influence the outcomes of this study

Are unable to provide informed consent

Have a history or presence of psychiatric, psychological, or neurological 
disorder(s)

Have not had at least one drink containing alcohol per month over the past six 
months

Have a serious medical illness (e.g., hepatitis, HIV/AIDS)

Have a history of drug or alcohol dependence

Currently use opioid medications on a regular or as-needed basis for any 
reason

Regularly smoke cigarettes or use tobacco/nicotine products
a) In general, what is the purpose of the research, how long will you be 
involved?  
The purpose of this research study is to test how alcohol affects sensory function 
in people with and without chronic facial pain. This study has 3 total sessions. 
Your screening visit will take approximately 1 to 2 hours, and the 2 laboratory 
sessions will require 4 to 8 hours each. These sessions will typically occur over a 
period of about 2-3 weeks.
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b) What is involved with your participation, and what are the procedures to be 
followed in the research? 
Participating in this study involves 3 different visits to our laboratory, including 
this screening session. During screening, you will complete a number of 
questionnaires and pressure-based pain and sensory testing. During the 
following two laboratory sessions, you will consume a beverage that may or may 
not contain alcohol and undergo the same pressure-based testing. We provide 
transportation to and from laboratory sessions using a rideshare service (Uber or 
Lyft). See Item #7 below for additional details. 
c) What are the likely risks or discomforts to you? 
Briefly, potential risks involved with participating in this study include alcohol 
intoxication and discomfort from the pressure testing. Other potential risks and 
discomforts are described in detail in Item #10 below.
d) What are the likely benefits to you or to others from the research?
There is no direct benefit to you for participating in this study. However, society-
at- large and the medical community may benefit by enhancing our 
understanding of how alcohol affects pain and sensory function in people with 
and without chronic facial pain. 
e) What are the appropriate alternative procedures or courses of treatment, if 
any, that might be helpful to you?  
Participating in this study is entirely optional. This is not a treatment study. If you 
are a faculty/staff member or student at the University of Florida, your decision 
whether to participate will have no impact on your employment or academic 
status. 
Additional and more detailed information is provided within the remainder of this 
Informed Consent form. Please read carefully before deciding if you wish to 
participate in this study.
WHAT CAN YOU EXPECT IF YOU PARTICIPATE IN THIS STUDY?
6.   What will be done as part of your normal clinical care (even if you did not 
participate in this research study)? 
Your normal clinical care will not be affected by participation in this study.
7.  What will be done only because you are in this research study? 
Initial screening procedures will include:
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a) After arriving at the Center for Pain Research and Behavioral Health (located 
on the ground floor of the UF Dental Tower in room DG-64, 67, and 68), the 
Informed Consent form will be reviewed with you to make certain that you 
understand everything that is involved in the study procedures. All study 
procedures will take place within a private testing room. 
b) You will complete several questionnaires about your demographics (age, 
education, etc.), family history of drug and alcohol use (including nicotine), 
typical drinking behavior, affect and personality, attitudes about alcohol, beliefs 
about pain, and medical history.
c) If you have jaw pain, Dr. Neubert will complete a brief orofacial pain 
assessment to determine the type of jaw pain that you have. 
d) You will complete sensory testing, which involves application of pressure to the 
face at the insertion of the masseter muscle. The masseter muscle assists with 
chewing foods. During this procedure, we will mark this location on your face 
with ink. Using a device called a “pressure algometer”, we will determine what 
level of pressure is painful to you and ask you to rate the level of pain, if any, 
you experience when specific levels of pressure are applied to this location. 
You can discontinue the procedures at any time so you do not experience pain 
you find intolerable. 
The 2 laboratory sessions involve the following procedures:
a) Both laboratory sessions occur in our laboratory (DG-64/67/68). You will be 
asked to fast for at least 4 hours prior to your scheduled session and abstain 
from alcohol consumption 24 hours before each session. You should also 
avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) in the 12 hours 
before your session. You should also not take any OTC medications (including 
allergy medications and analgesics) in the morning before your session.  
Normal morning medications are generally permitted but you should not take 
any medications that may have harmful interactions with alcohol. This includes 
drugs that may make you drowsy, like opioid-based medications or 
benzodiazepines. If you are not able to meet these requirements, please let us 
know as soon as possible so your laboratory session can be rescheduled.
b) We will provide transportation to and from the laboratory using a ride-share 
service (Uber or Lyft).
c) You will be screened via urine analysis for recent use of disqualifying drugs, 
including marijuana, cocaine, benzodiazepines, morphine, and 
methamphetamine. 
d) You will also be initially screened for recent alcohol consumption using a 
standard breathalyzer, which must be negative. If results of this test or the 
urine drug screen are positive, you will be discontinued or your session will be 
rescheduled at the PI’s discretion.
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e) If you are of childbearing potential, you will be given a pregnancy test. If the 
test is positive, the results will be destroyed and you will be discontinued from 
the study. The study team will recommend that you contact your physician. 
f)
You will be provided with breakfast and a light lunch.
g) You will complete paper/pencil mood assessments of your mood. 
h) You will be given your beverage, which will consist of alcohol (if any) mixed 
with sugar-free lemon-lime soda. Once finished, you will be asked to rinse your 
mouth thoroughly with water.
i)
You will then be asked to complete assessment regarding your intoxication 
level. You will also periodically breathe into a breathalyzer.
j)
After drinking the beverage, you will complete brief paper/pencil assessments 
and undergo pressure-based sensory testing like that conducted during the 
screening session. 
k) After testing is completed and your breath alcohol concentration is at or below 
0.02 g/dL, you will be transported home using Uber or Lyft.
Once this research study is completed, any information that could identify you might 
be removed from any identifiable private information collected. After such removal, the 
information could be used for future research studies or distributed to another 
investigator for future research studies without additional informed consent from you or 
your legally authorized representative
If you have any questions now or at any time during the study, please contact one of 
the research team members listed in question 3 of this form.
8.
How long will you be in this research study?
This study has 3 total sessions. Your screening visit will take approximately 1 to 2 
hours, and the 2 laboratory sessions will require 4 to 8 hours each. These sessions 
will typically occur over a period of about 2-3 weeks.
9.
How many people are expected to take part in this research study?
Up to 110 people may be screened for this study. Our goal is for at least 50 people to 
complete all study procedures.
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WHAT ARE THE RISKS AND BENEFITS OF THIS STUDY AND 
WHAT ARE YOUR OPTIONS?
10. What are the possible discomforts and risks from taking part in this research 
study?
This study might involve the following risks and discomforts to you:

You may feel intoxicated after consuming the alcohol dose used in this study. 
Alcohol consumption may result in nausea and/or vomiting, as well as 
drowsiness, gastrointestinal upset, impaired memory and concentration, and 
decreased inhibitions. This may result in impairment to your normal function. 
However, the alcohol effects will have worn off by the end of laboratory 
sessions and assurance will be made that you are not intoxicated before you 
are transported home.

You may feel uncomfortable answering questions about private topics during 
screening and laboratory sessions. However, you may choose not to answer 
any questions that make you feel uncomfortable. 

Certain medications may have harmful interactions with alcohol. For this 
reason, you will not be allowed to participate in the study if you use 
prescription medications that cause drowsiness (for example, benzodiazepines 
or opioids for pain). 

There are minimal risks associated with our pressure sensory testing. This 
includes pain that is not expected to last for longer than 90 seconds. The 
testing procedure may be uncomfortable or unpleasant; however, if the pain is 
greater than you wish to tolerate, you may discontinue the procedures at any 
time without penalty. It is possible, but very unlikely, that bruising could result 
from this procedure.

Other possible risks to you may include dizziness or lightheadedness from 
breathalyzer testing.

There is a risk of spreading or contracting COVID-19 during participation in this 
study. We are taking the following steps to limit spread of COVID-19:
o
During screening visits, which do not involve the use of a breathalyzer, 
research staff will wear a disposable Level 1 surgical mask during all 
interactions with you or other staff members. During laboratory visits, 
which do involve the use of a breathalyzer and production of aerosols, 
research staff will wear a KN95 mask. If you arrive for a study session 
and do not have a mask, please wait outside the Shands Dental Tower 
West Entrance, inform our staff of your arrival (352-273-5220), and wait 
for a research assistant to come outside and provide you with one. You 
are required to wear the mask for the duration of all sessions, except 
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when otherwise instructed (e.g. when drinking a beverage or providing a 
breath sample).
▪
If you are not willing to wear a mask, we ask that you do not 
participate in this study.
o
At the beginning of each study session, all screening material 
documents will be presented to you. You will be instructed when to flip 
to the next page, to reduce the number of times forms are passed 
between people. Writing instruments will be designated for participants 
and disinfected between study sessions.
o
All study equipment will be sanitized before and after each use. Study 
equipment includes, but is not limited to: tabletops, door knobs, 
clipboards, pressure algometers for QST procedures, beverage tray, 
and breathalyzers.
Researchers will take appropriate steps to protect any information they collect about 
you. However, there is a slight risk that information about you could be revealed 
inappropriately or accidentally. Depending on the nature of the information, such a 
release could upset or embarrass you, or possibly affect your insurability or 
employability. Questions 17-21 in this form discuss what information about you will be 
collected, used, protected, and shared.
To help us protect your privacy, we have been granted a Certificate of Confidentiality 
from the National Institutes of Health. With this Certificate, the researchers cannot be 
forced to disclose information that may identify you, even by a court subpoena, in any 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings. 
The researchers will use the Certificate to resist any demands for information that 
would identify you, except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of 
the United States Government that is used for auditing or evaluation of federally 
funded projects or for information that must be disclosed in order to meet the 
requirements of the federal Food and Drug Administration (FDA).
You have been informed that a Certificate of Confidentiality does not prevent you from 
voluntarily releasing information about yourself or your involvement in this research. If 
an insurer, employer, or other person obtains your written consent to receive research 
information, then the researchers may not use the Certificate to withhold that 
information. That is, if you give written consent for the release of information, we 
cannot withhold that information and we cannot hold responsibility for how that person 
may use your information. 
The Certificate of Confidentiality does not prevent the researchers from disclosing 
voluntarily, without your consent, information that would identify you as a participant in 
the research project under the following circumstances. If we learn about child abuse, 
elder abuse, or intent to harm yourself or others, we will report that information to 
appropriate authorities.
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It is possible that once this information is shared with authorized persons, it could be 
shared by the persons or agencies who receive it and it would no longer be protected 
by the federal medical privacy law. It is possible that once this information is shared 
with authorized persons, it could be shared by the persons or agencies who receive it 
and it would no longer be protected by the federal medical privacy law.
This study may include risks that are unknown at this time.
Participation in more than one research study or project may further increase the risks 
to you. If you are already enrolled in another research study, please inform one of the 
research team members listed in question 3 of this form or the person reviewing this 
consent with you before enrolling in this or any other research study or project.
Throughout the study, the researchers will notify you of new information that may 
become available and might affect your decision to remain in the study. 
If you wish to discuss the information above or any discomforts you may experience, 
please ask questions now or call one of the research team members listed in question 
3 in this form.
11a. What are the potential benefits to you for taking part in this research study?
There is no direct benefit to you for participating in this study.
11b. How could others possibly benefit from this study?
Improving understanding of how alcohol use affects pain and sensory function in 
people with chronic orofacial pain conditions like jaw pain and TMD may allow us to 
make better recommendations for reducing risk associated with drinking.
11c. How could the researchers benefit from this study?
In general, presenting research results helps the career of a scientist. Therefore, the 
Principal Investigator listed in question 3 of this form may benefit if the results of this 
study are presented at scientific meetings or in scientific journals.
12. What other choices do you have if you do not want to be in this study? 
Participating in this study is entirely optional. This is not a treatment study.
13a. Can you withdraw from this study?
You are free to withdraw your consent and to stop participating in this study at any 
time. If you do withdraw your consent, you will not be penalized in any way and you 
will not lose any benefits to which you are entitled.  If you decide to withdraw your 
consent to participate in this study for any reason, please contact one of the research 
team members listed in question 3 of this form. They will tell you how to stop your 
participation safely.
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If you have any questions regarding your rights as a research subject, please call the 
Institutional Review Board (IRB) office at (352) 273-9600.
13b.If you withdraw, can information about you still be used and/or collected?
If you choose to withdraw from the study, no new information will be collected. The 
information already collected could still be used to complete the study.
13c. Can the Principal Investigator withdraw you from this study? 
You may be withdrawn from the study without your consent for the following reasons:

The study is cancelled and/or discontinued, or other administrative reasons.

You have an adverse reaction to the alcohol dose or pain sensitivity testing.

You have recently used medications or drugs that are not allowed, or you are 
pregnant. 

You have not followed pre-test instructions.
WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE?
14. If you choose to take part in this research study, will it cost you anything?
There will be no cost to you for participating in this research study.
15. Will you be paid for taking part in this study?
Yes. You will receive a $15 gift card for completing the screening session, and your 
gift card will be loaded with $50 for each laboratory session. The total amount you will 
be paid for completing all study procedures is $115. You will receive partial payment if 
you do not complete all study procedures.
Your payment for participation in this research study is handled through the University 
of Florida’s Human Subject Payment (HSP) Program. Your information, which will 
include your name, address, and date of birth, is protected. Access to the (HSP) 
Program site is limited to certain staff with the assigned security role. You will be 
randomly assigned a specific identification (ID) number to protect your identity. 
The study team will provide you with an informational form called the Prepaid Card 
Facts document. If you have any problems regarding your payment call the HSP 
Office (352) 392-9057. 
If you are paid more than $75 for taking part in this study, your name and social 
security number will be reported to the appropriate University employees for purposes 
of making and recording the payment as required by law. You are responsible for 
paying income taxes on any payments provided by the study. Payments to 
nonresident aliens must be processed through the University of Florida Payroll and 
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Tax Services department. If the payments total $600 or more in a calendar year, the 
University must report the amount you received to the Internal Revenue Service 
(IRS). The IRS is not provided with the study name or its purpose. If you have 
questions about the collection and use of your Social Security Number, please visit: 
http://privacy.ufl.edu/SSNPrivacy.html.
16. What if you are injured because of the study?  
If you are injured as a direct result of your participation in this study, only the 
professional services that you receive from any University of Florida Health Science 
Center healthcare provider will be provided without charge. These healthcare 
providers include physicians, physician assistants, nurse practitioners, dentists or 
psychologists. Any other expenses, including Shands hospital expenses, will be billed 
to you or your insurance provider. 
You will be responsible for any deductible, co-insurance, or co-payments. Some 
insurance companies may not cover costs associated with research studies or 
research-related injuries. Please contact your insurance company for additional 
information. 
The Principal Investigator will determine whether your injury is related to your 
participation in this study. 
No additional compensation is routinely offered. The Principal Investigator and others 
involved in this study may be University of Florida employees. As employees of the 
University, they are protected under state law, which limits financial recovery for 
negligence.
Please contact one of the research team members listed in question 3 of this form if 
you experience an injury or have questions about any discomforts that you 
experience while participating in this study.
17. How will your health information be collected, used and shared?
If you agree to participate in this study, the Principal Investigator will create, collect, 
and use private information about you and your health. This information is called 
protected health information or PHI. In order to do this, the Principal Investigator 
needs your authorization. The following section describes what PHI will be collected, 
used and shared, how it will be collected, used, and shared, who will collect, use or 
share it, who will have access to it, how it will be secured, and what your rights are to 
revoke this authorization. 
Your protected health information may be collected, used, and shared with others to 
determine if you can participate in the study, and then as part of your participation in 
the study. This information will be gathered only through your self-report, participation 
in study procedures, or from your study visits or telephone calls. More specifically, the 
following information may be collected, used, and shared with others:
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a) Your name, research record number, contact information, and dates 
associated with tests related to your participation
b) Social security number (for payment purposes)
c) Date/time of negative pregnancy tests (results of positive tests are 
destroyed) 
d) Demographic and health status information
e) Responses to questionnaires
f)
Results of laboratory tests
This information will be stored in locked filing cabinets or on computer servers with 
secure passwords, or encrypted electronic storage devices. 
Some of the information collected could be included in a "limited data set" to be used 
for other research purposes. If so, the limited data set will only include information that 
does not directly identify you. For example, the limited data set cannot include your 
name, address, telephone number, social security number, photographs, or other 
codes that link you to the information in the limited data set. If limited data sets are 
created and used, agreements between the parties creating and receiving the limited 
data set are required in order to protect your identity and confidentiality and privacy.
18. For what study-related purposes will your protected health information be 
collected, used, and shared with others?
Your PHI may be collected, used, and shared with others to make sure you can 
participate in the research, through your participation in the research, and to evaluate 
the results of the research study. More specifically, your PHI may be collected, used, 
and shared with others to determine how alcohol intake affects pain and sensory 
function in people with and without jaw pain conditions, including TMD.
Once this information is collected, it becomes part of the research record for this 
study.  
19. Who will be allowed to collect, use, and share your protected health 
information?
Only certain people have the legal right to collect, use and share your research 
records, and they will protect the privacy and security of these records to the extent 
the law allows. These people include:

the study Principal Investigator (listed in question 3 of this form) and research 
staff associated with this project.

other professionals at the University of Florida or Shands Hospital that provide 
study-related treatment or procedures.

the University of Florida Institutional Review Board (IRB; an IRB is a group of 
people who are responsible for looking after the rights and welfare of people 
taking part in research).  
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20. Once collected or used, who may your protected health information be shared 
with?
Your PHI may be shared with:

Research staff at the University of Florida associated with this project.

The study sponsor (listed in Question 4 of this form).

United States governmental agencies who are responsible for overseeing 
research, such as the Food and Drug Administration, the Department of Health 
and Human Services, and the Office of Human Research Protections
.

Government agencies who are responsible for overseeing public health 
concerns such as the Centers for Disease Control and federal, state and local 
health departments.
Otherwise, your research records will not be released without your permission unless 
required by law or a court order. It is possible that once this information is shared with 
authorized persons, it could be shared by the persons or agencies who receive it and 
it would no longer be protected by the federal medical privacy law.  
21. If you agree to take part in this research study, how long will your protected 
health information be used and shared with others?
Your PHI will be used and shared with others until the end of the study.
You are not required to sign this consent and authorization or allow researchers to 
collect, use and share your PHI. Your refusal to sign will not affect your treatment, 
payment, enrollment, or eligibility for any benefits outside this research study. 
However, you cannot participate in this research unless you allow the collection, use 
and sharing of your protected health information by signing this consent and 
authorization.
You have the right to review and copy your protected health information.  However, 
we can make this available only after the study is finished.
You can revoke your authorization at any time before, during, or after your 
participation in this study. If you revoke it, no new information will be collected about 
you. However, information that was already collected may still be used and shared 
with others if the researchers have relied on it to complete the research. You can 
revoke your authorization by giving a written request with your signature on it to the 
Principal Investigator.
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SIGNATURES
As an investigator or the investigator’s representative, I have explained to the participant 
the purpose, the procedures, the possible benefits, and the risks of this research study; 
the alternative to being in the study; and how the participant’s protected health 
information will be collected, used, and shared with others: 
Signature of Person Obtaining Consent and 
Authorization
Date
You have been informed about this study’s purpose, procedures, possible benefits, and 
risks; the alternatives to being in the study; and how your protected health information will 
be collected, used and shared with others. You have received a copy of this Form. You 
have been given the opportunity to ask questions before you sign, and you have been told 
that you can ask questions at any time.  
You voluntarily agree to participate in this study. You hereby authorize the collection, use 
and sharing of your protected health information as described in sections 17-21 above. By 
signing this form, you are not waiving any of your legal rights.
Signature of Person Consenting and Authorizing
Date
 
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