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Stress, Hormones, and Eating

NCT01175512 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-01-28

No results posted yet for this study

Summary

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.

Conditions

  • Food Addiction
  • How Opioid Tone Was Related to Self Reported
  • Drive to Eat Using a Measure of Food Addiction

Interventions

DRUG

Naltrexone

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Elissa Epel, PhD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-12-31
Completion
2011-12-31
FDA Drug
Yes

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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 NCT01175512 on ClinicalTrials.gov