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临床试验/NCT01175512
NCT01175512已完成早期 1 期

Novel Interventions to Reduce Stress Induced Non-homeostatic Eating

University of California, San Francisco0 个研究点目标入组 42 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
42
主要终点
Ideal Dosage

研究概览

简要总结

The investigators will develop a measure of endogenous opioid tone that might serve as a biological marker for drive for palatable food. Using a 'naltrexone probe,' the investigators will assess whether individual response to one dose of an opioid receptor antagonist, naltrexone, is related to non-homeostatic eating in non-pregnant women.

Hypothesis 1: Naltrexone Response will be related to non-homeostatic eating.

Hypothesis 2: Response profiles to the 25 mg dose will be slightly less in magnitude than the 50 mg dose. However, responses will be similarly related to non-homeostatic eating measures.

Hypothesis 3: Response to naltrexone will be highly stable within individuals across time, in the absence of an intervention.

详细描述

Opioid tone may provide a way to identify people at risk of reward based eating, with more accuracy than self-report measures. Knowing such risk could improve treatment matching, and provide a biomarker to assess treatment progress. There is no direct measure of central opioid activity in humans, short of PET scans for opioid receptor binding. However, there is a promising indicator using an opioid antagonist such as naltrexone. Blocking opioid receptor releases the inhibitory opioidergic inputs to hypothalamic corticotropic releasing hormone (CRH) neurons, thus increasing CRH, and eventually cortisol in the blood. The extent of the cortisol rise in response to naltrexone might serve as an indicator of endogenous opioidergic tone. It is hypothesized that greater increases in cortisol indicate weaker endogenous opioid activity (by indicating a more complete opioid blockade). Salivary cortisol response to naltrexone may offer a relatively safe and unobtrusive way to measure endogenous opioidergic tone. We propose to test the reliability and validity of the naltrexone probe, taken at home, as a measure of endogenous opioidergic tone. In a previous study (Daubenmier et al, 2013), we administered a one time 50mg dose of naltrexone and examined nausea and cortisol responses. Results suggested that responses were higher in those who showed greater drive to eat. Here we examine a more direct measure of drive to eat, using the Yale Food Addiction Scale (YFAS), and test whether nausea and cortisol responses were associated with greater drive to eat, whether 50mg produced greater responses than 25 mg, and whether the responses were stable (highly related) when tested again one month later.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age > 20 to 45 years (pre-menopausal women)
  • BMI > 30 and no larger than BMI = 40 or 300 pounds

排除标准

  • Inability to provide informed consent or speak English
  • Needle phobic or fainting in response to blood draw
  • Currently pregnant or breastfeeding
  • Currently Smoke
  • Bulimia (Binge Eating Disorder is common among the obese, and allowed)
  • Pacemaker
  • Shift Worker
  • Beta Blocker Medication use
  • Liver Medication use
  • Weight Loss Medication use
  • Chronic current use of cortisol containing medications
  • Kidney Disease (based on elevated Blood Urea Nitrogen and Creatinine)
  • Illegal Drug Use (presence in urine)
  • Liver Cirrhosis or Acute hepatitis (based on elevated Alanine transaminase)
  • Substance abuse, mental health, or medical condition that, in the opinion of investigators, will affect study outcomes (e.g., hypertension, severe food allergies).

研究组 & 干预措施

Naltrexone

Active Comparator

4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.

干预措施: Naltrexone (Drug)

Placebo

Placebo Comparator

4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.

干预措施: Placebo (Drug)

结局指标

主要结局

Ideal Dosage

时间窗: May 2012

1) To examine criterion validity by testing whether level of opioid tone (based on response to naltrexone probe) is associated with self reported scores on non-homeostatic eating measures, behavioral and cognitive tasks assessing constructs related to addiction (eg, impulsivity) and ideal dosage (25 vs. 50 mg) in 60 obese women.

次要结局

  • Test Retest Reliability(May 2012)
  • Home Based Measures Reliability(May 2012)

研究者

申办方类型
Other
责任方
Sponsor

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