Pexacerfont for Stress-induced Food Craving

Stopped early · Early Phase 1

Conditions studied: Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days, Followed, Placebo

In brief

Background: \- 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. Objectives: \- To see if pexacerfont can help reduce stress-induced food cravings. Eligibility: \- Individuals between 21 and 65 years of age who are on a diet to control their weight. Design: * 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.

Key facts

Study ID

NCT01656577

Run by

National Institute on Drug Abuse (NIDA)

People needed

31

Starts

2012-06-01

Expected to finish

2015-09-01

Last updated by the study team

2016-08-18

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Current employment at NIDA IRP or Bristol-Myers Squibb (BMS), or being in the immediate family of an employee. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
• Current participation in another clinical study that includes exposure to an investigational or non-investigational drug or device.
• Participation in a clinical study for a condition related to weight or dieting within the preceding month.
• Any history of participation in a trial involving pexacerfont or closely related compounds.
• Any medical condition or laboratory finding that, in the judgment of the investigators, could adversely affect safety or study integrity. Examples include but are not limited to diabetes type 1 and type 2, ischemic heart disease, uncontrolled hypertension, and history of cerebrovascular accident or transient ischemic attack.
• For women: pregnancy, breastfeeding, or planning to become pregnant within 6 months from the administration of first dose of study drug.
• Past or present diagnosis of any eating disorder, including Anorexia Nervosa, Bulimia Nervosa, and Eating Disorder NOS (e.g., Binge-Eating Disorder). (Eating-disordered individuals probably represent a distinct population and should therefore be studied separately.)
• Past or present diagnosis of schizophrenia, bipolar disease, or any psychotic disorder; past or present diagnosis of dementia or any other disorder that has led to a clinically significant cognitive impairment; present diagnosis of any mood or anxiety disorder; any other psychiatric condition that presently requires, or in the past month has required, pharmacological intervention.
• Past or present diagnosis of any substance-use disorder except nicotine dependence.
• Urine tests positive for illegal drugs.
• Evidence of thyroid disorder by medical history or screening physical exam, with TSH < 0.36 or greater than 3.74 UIU/ml; or current or history of use of thyroid medication.
• Adrenal or pituitary pathology as evidenced by medical history or suggested by abnormal screening labs.
• Current seizure disorder or a significant history (as judged by the investigators) of a seizure disorder, other significant neurological disorders (e.g., Parkinson's Disease, multiple sclerosis, stroke, neurodegenerative disease, cerebral palsy) or severe head trauma (including closed head trauma, penetrating head injury, skull fracture, or intracranial hemorrhage), or CNS tumor.
• Active liver disease or a history of hepatic intolerance to medications that, in the investigators' judgment, is medically significant.
• History of diabetes mellitus type I and II or gastric bypass or reduction surgery.
• Justification: illnesses that change metabolism or the absorption from the GI tract, would interfere with drug metabolism or absorption).
• Difficulty swallowing tablets or capsules.
• Exclusionary physical and laboratory test findings:
• QTc > 475 msec
• platelets less than or equal to 75,000/mm(3)
• hemoglobin less than or equal to 9g/dL
• neutrophils, absolute less than or equal to 1000/mm3
• SGOT (AST) > 2.5 times upper limit of normal
• SGPT (ALT) > 2.5 times upper limit of normal
• bilirubin 2 times upper limit of normal

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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