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Pexacerfont for Stress-induced Food Craving

NCT01656577 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-08-18

No results posted yet for this study

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

Interventions

DRUG

Pexacerfont

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • David H Epstein, Ph.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656577 on ClinicalTrials.gov