No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 65
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
160 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for adults aged 21 to 65 who experience chronic pain from jaw disorders. Participants will share their drinking habits and take part in evaluations both in a lab and in daily life.
Are You a Good Fit for This Trial?
You may be able to join if
I am 21 to 65 years old.
I drink at least 1 alcoholic drink on 3 days each week on average.
I have been diagnosed with temporomandibular disorder.
I can speak and understand English well.
I own a smartphone with internet access.
You may not be able to join if
I have used opioid painkillers in the past month.
I have current major depression.
I have a history of any psychotic disorder.
I have uncontrolled high blood pressure or diabetes.
I have a serious medical illness like HIV/AIDS.
I have trouble with my thinking or memory.
I have a history of substance use disorder.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Individuals with chronic temporomandibular disorder (TMD) pain are at increased risk for alcohol-related consequences compared to those without pain, and growing evidence suggests pain is a potent motivator for alcohol use in many individuals. However, few systematic examinations of modifiable and non-modifiable risk factors, including orofacial pain status, have been conducted. This project addre…
Individuals with chronic temporomandibular disorder (TMD) pain are at increased risk for alcohol-related consequences compared to those without pain, and growing evidence suggests pain is a potent motivator for alcohol use in many individuals. However, few systematic examinations of modifiable and non-modifiable risk factors, including orofacial pain status, have been conducted. This project addresses this gap in knowledge by determining the effect of pain on drinking topography in heavy drinkers with and without chronic TMD pain in both the laboratory and daily life.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participants in this study must be 21 years to 65 years of age and provide a driver's license or other state-issued ID.
* Participants must also be sufficiently fluent in English to provide informed consent and understand questionnaires and instructions for laboratory procedur…
Inclusion Criteria:
* Participants in this study must be 21 years to 65 years of age and provide a driver's license or other state-issued ID.
* Participants must also be sufficiently fluent in English to provide informed consent and understand questionnaires and instructions for laboratory procedures.
* Participants must report drinking of, on average, at least 1 drink 3 days/week over the past 6 months.
* Meet Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for myalgia (masticatory muscle pain), arthralgia (TMJ pain), or a combination (Schiffman et al., 2014) (TMD group only).
* Own a smartphone with internet access.
* Use of prescription medications will be allowed, provided they do not contraindicate alcohol use.
Exclusion Criteria:
* Use of opioid analgesics within the past month;
* Current major depression;
* History of any psychotic disorder;
* Under-controlled 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;
* History of substance use disorder (including nicotine/tobacco);
* Alcohol naïve
* Alcohol use disorder, or currently attempting to quit or cut down on using alcohol
* Positive pregnancy test
* Breastfeeding or intending to become pregnant
* Loss of sensation in the lower leg
* Inability to complete study tasks due to weakness, immobilization, or loss of limbs
* Chronic pain (Control group only)
* 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.
* Medications that contraindicate alcohol use
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