Pexacerfont for Stress-induced Food Craving

NCT01656577 | Terminated Early Phase 1

• 2 other identifiers: 99991247512-DA-N475
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

CRF1 antagonist; Stress; Eating Behavior; Food Craving

Interventions

Pexacerfont DRUG

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) \> 22 kg/m(2)
• Score of 15 or higher on the Dietary Restraint Scale, with endorsement of the Restraint
• Scale item Do you give too much time and thought to food?
• Age 21 - 65 years.
• (4b) Men, unless surgically sterilized (vasectomy with documentation of azoospermia), must agree to practice abstinence or use barrier contraception, and not donate sperm, for a period of 6 months beginning from first dose of randomized treatment.

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Avena NM, Rada P, Hoebel BG. Evidence for sugar addiction: behavioral and neurochemical effects of intermittent, excessive sugar intake. Neurosci Biobehav Rev. 2008;32(1):20-39. doi: 10.1016/j.neubiorev.2007.04.019. Epub 2007 May 18.

  PMID: 17617461 BACKGROUND

• Binneman B, Feltner D, Kolluri S, Shi Y, Qiu R, Stiger T. A 6-week randomized, placebo-controlled trial of CP-316,311 (a selective CRH1 antagonist) in the treatment of major depression. Am J Psychiatry. 2008 May;165(5):617-20. doi: 10.1176/appi.ajp.2008.07071199. Epub 2008 Apr 15.

  PMID: 18413705 BACKGROUND

• Cottone P, Sabino V, Roberto M, Bajo M, Pockros L, Frihauf JB, Fekete EM, Steardo L, Rice KC, Grigoriadis DE, Conti B, Koob GF, Zorrilla EP. CRF system recruitment mediates dark side of compulsive eating. Proc Natl Acad Sci U S A. 2009 Nov 24;106(47):20016-20. doi: 10.1073/pnas.0908789106. Epub 2009 Nov 9.

  PMID: 19901333 BACKGROUND

• Epstein DH, Kennedy AP, Furnari M, Heilig M, Shaham Y, Phillips KA, Preston KL. Effect of the CRF1-receptor antagonist pexacerfont on stress-induced eating and food craving. Psychopharmacology (Berl). 2016 Dec;233(23-24):3921-3932. doi: 10.1007/s00213-016-4424-5. Epub 2016 Sep 5.

  PMID: 27595147 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Interventions

pexacerfont

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• David H Epstein, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 3, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 18, 2016

Record last verified: 2012-06

Locations

US (1)