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临床试验/NCT03311594
NCT03311594已完成1 期

The Alcohol-Pain Connection: Mechanisms and Genetic/Psychological Correlates

Syracuse University1 个研究点 分布在 1 个国家目标入组 379 人开始时间: 2019年5月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
379
试验地点
1
主要终点
Alcohol Urge/Consumption

研究概览

简要总结

The societal impact of heavy alcohol consumption and chronic pain is substantial and warrants the existing research investment into their etiology and treatment. Moreover, evidence of significant co-occurrence between these conditions offers an opportunity to examine mechanisms in the alcohol-pain connection that may inform the development of novel treatments. Consistent with NIH PA-15-026 (Mechanistic Studies of Pain and Alcohol Dependence), the goal of the proposed study is to examine several complex and potentially bidirectional relations between pain and alcohol in one overarching model, which has never been attempted in a human experimental paradigm. The primary study aims are as follows: (1) to conduct the first test of both pharmacological and expectancy effects in acute alcohol analgesia among humans; (2) to conduct the first test of pain as a proximal antecedent of urge to drink and ad lib alcohol consumption, and to test whether acute analgesic effects predict pain-induced alcohol urge/consumption; (3) to test associations between study outcomes and candidate genetic polymorphisms that have been implicated in pain-alcohol processes; and (4) to conduct exploratory analyses of gender and pain relevant cognitive-affective factors as moderators of these outcomes. Participants will include 280 moderate-to-heavy drinkers recruited from the local community. Experimental methods will include alcohol administration (moderate dose vs. low dose vs. placebo vs. control) and pre/post assessment of static/dynamic pain responses, and capsaicin/heat pain induction (vs. no pain induction) followed by assessment of urge to drink and ad lib alcohol consumption. By employing a novel experimental paradigm, the study results will provide internally valid data with clear and direct implications for translating these findings to clinical applications. It is our expectation that this work will catalyze future research and inform clinical practice by establishing an experimental platform that allows for the demonstration of causal effects, the evaluation of treatment components prior to conducting costly clinical trials, and the identification of important theory-based biopsychosocial mechanisms that can inform the development of novel integrated treatments for individuals with co-occurring pain and alcohol use disorders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
21 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • be 21-64 years of age
  • be classified as a moderate or heavy drinker based on the Quantity-Frequency-Variability Questionnaire, which will assure that participants currently (last 3 months) consume alcohol in amounts similar to what will be administered or available in the proposed experiments

排除标准

  • current acute or chronic pain
  • chili pepper allergies (contraindicated for capsaicin)
  • current use of prescription pain medications
  • any possibility of being pregnant (verified at session via a pregnancy test)
  • self-reported history of or treatment for psychiatric or alcohol/other drug problems
  • participants who are under the age of 21 or who do not have a government issued ID; and
  • medical conditions that contraindicate the use of alcohol (e.g., diabetes, liver disease).

研究组 & 干预措施

Placebo Alcohol Consumption and No Pain Induction

Placebo Comparator

Condition 1: Placebo alcohol consumption Condition 2: No pain group

干预措施: Placebo Alcohol (Drug)

Low Alcohol Consumption and No Pain Induction

Experimental

Condition 1: Low alcohol consumption Condition 2: No pain group

干预措施: Low Alcohol (Drug)

Low Alcohol Consumption and No Pain Induction

Experimental

Condition 1: Low alcohol consumption Condition 2: No pain group

干预措施: No Pain Induction (Other)

Low Alcohol Consumption and Pain Induction

Experimental

Condition 1: Low alcohol consumption Condition 2: Pain group

干预措施: Low Alcohol (Drug)

Low Alcohol Consumption and Pain Induction

Experimental

Condition 1: Low alcohol consumption Condition 2: Pain group

干预措施: Pain Induction (Other)

Moderate Alcohol Consumption and No Pain Induction

Experimental

Condition 1: Moderate alcohol consumption Condition 2: No pain group

干预措施: Moderate Alcohol (Drug)

Moderate Alcohol Consumption and No Pain Induction

Experimental

Condition 1: Moderate alcohol consumption Condition 2: No pain group

干预措施: No Pain Induction (Other)

Moderate Alcohol Consumption and Pain Induction

Experimental

Condition 1: Moderate alcohol consumption Condition 2: Pain group

干预措施: Moderate Alcohol (Drug)

Moderate Alcohol Consumption and Pain Induction

Experimental

Condition 1: Moderate alcohol consumption Condition 2: Pain group

干预措施: Pain Induction (Other)

Placebo Alcohol Consumption and No Pain Induction

Placebo Comparator

Condition 1: Placebo alcohol consumption Condition 2: No pain group

干预措施: No Pain Induction (Other)

Placebo Alcohol Consumption and Pain Induction

Experimental

Condition 1: Placebo alcohol consumption Condition 2: Pain group

干预措施: Placebo Alcohol (Drug)

Placebo Alcohol Consumption and Pain Induction

Experimental

Condition 1: Placebo alcohol consumption Condition 2: Pain group

干预措施: Pain Induction (Other)

Control and No Pain Induction

Placebo Comparator

Condition 1: No alcohol consumption Condition 2: No pain group

干预措施: No Pain Induction (Other)

Control and Pain Induction

Experimental

Condition 1: No alcohol consumption Condition 2: Pain group

干预措施: Pain Induction (Other)

结局指标

主要结局

Alcohol Urge/Consumption

时间窗: 15 minutes

Amount of alcohol consumed and self-reported urge to drink

Pain Response

时间窗: 40 minutes

Pain Quantitative Sensory Testing before and after beverage consumption

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph W. Ditre

Professor

Syracuse University

研究点 (1)

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