JIT: Effects of Pain on Laboratory Drinking Topography and Daily Drinking in People With Chronic Temporomandibular Disorder (TMD) Pain
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Alcohol Use Topography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
This study does not employ masking.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
TMD Group 2
People with an established diagnosis of temporomandibular disorder (TMD) assigned to sparkling water (control)
干预措施: control condition (Other)
Pain-free Control Group 2
People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to sparkling water (control)
干预措施: control condition (Other)
TMD Group 1
People with an established diagnosis of temporomandibular disorder (TMD) assigned to Ethanol intervention
干预措施: alcohol condition (Drug)
Pain-free Control Group 1
People without an established diagnosis of temporomandibular disorder (TMD) or other chronic pain condition assigned to Ethanol intervention
干预措施: alcohol condition (Drug)
结局指标
主要结局
Alcohol Use Topography
时间窗: 30 minutes
Variables reflecting microstructure of alcohol use during self-administration, including sip interval and sip volume.
Heat Pain Intensity
时间窗: 30 minutes
Pain intensity of heat stimuli applied during self- administration sessions.
次要结局
未报告次要终点