Pexacerfont for Stress-induced Food Craving
|ClinicalTrials.gov Identifier: NCT01656577|
Recruitment Status : Terminated
First Posted : August 3, 2012
Last Update Posted : August 18, 2016
- Stress can cause people to give in to temptations to eat less healthily. People who are on weight loss diets often have problems sticking to their diets when they are stressed. Some tests have shown that the drug pexacerfont can help reduce stress-related seeking of high-calorie foods. However, it has not been tested on reducing food craving. Researchers want to test pexacerfont on people who are on diets to see if it can reduce stress-related food cravings.
- To see if pexacerfont can help reduce stress-induced food cravings.
- Individuals between 21 and 65 years of age who are on a diet to control their weight.
- Participants will be screened with a physical exam and medical history. This study requires seven visits over about 35 days.
- Participants will take either pexacerfont or placebo pills during the study. They will have three pills every morning. They will record video of themselves taking the pills every day.
- Every evening, participants will fill out a questionnaire. It will ask questions about feelings and behaviors related to eating and food craving.
- Participants will have regular study visits while taking the pills. The visits will involve questions about stressful situations and food cravings. One visit will involve a mildly stressful math test, followed by tasting of different foods. This test will look at whether pexacerfont can affect food preferences. Participants will provide blood and saliva samples as directed at these study visits.
- Participants will have follow-up phone calls 1, 3, and 6 months after the end of the study.
|Condition or disease||Intervention/treatment||Phase|
|Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days, Followed Placebo||Drug: Pexacerfont||Early Phase 1|
Objective: To evaluate pexacerfont, an orally available, brain-penetrant selective CRF1 antagonist, for its ability to modulate food craving and consumption in chronic unsuccessful dieters.
Study population: We will collect evaluable data from up to 90 restrained eaters (individuals who indicate a history of chronic yo-yo dieting by scoring 15 or higher on the Dietary Restraint Scale). To ensure that all participants have some degree of preoccupation with food, an additional inclusion criterion will be endorsement of the Restraint Scale item Do you give too much time and thought to food? Apart from their preoccupation with food, participants will be healthy. They can be either normal-weight or overweight (Body Mass Index (BMI) > 22kg/m2); this will be stratified across dose groups.
Frank eating disorders will be exclusionary.
Design: This will be a randomized, double-blind, between-groups study with two groups.
Participants will be stabilized on either pexacerfont or placebo for 28 days (300 mg/day loading dose for 7 days, followed by 100 mg/day maintenance dose for 21 days). On day 15, they will undergo a math-test stressor and have stress-induced food consumption and craving assessed in a bogus taste test and on visual-analog scales. During three subsequent visits between days 16 and 28, they will be exposed to three personalized imagery-induction scripts-one stress-related, one food-related, and one neutral/relaxing. Food craving and food consumption will be assessed on those visits as well.
Outcome measures: The primary outcome measure is stress-induced eating after the math-test stressor. Other outcome measures will include spontaneous food consumption after the other stressors, subjective ratings of stress, mood, and food craving, autonomic responses (galvanic skin response (GSR), heart rate, and blood pressure), and endocrine responses (salivary cortisol, salivary alpha-amylase, and serum cortisol).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pexacerfont for Reduction of Stress-Induced Food Craving and Eating in Humans|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656577
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||David H Epstein, Ph.D.||National Institute on Drug Abuse (NIDA)|