Stress, Hormones, and Eating (SHE)

January 25, 2021 updated by: University of California, San Francisco

Novel Interventions to Reduce Stress Induced Non-homeostatic Eating

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Opioid tone may provide a way to identify people at risk of reward based eating, with more accuracy than self-report measures. Knowing such risk could improve treatment matching, and provide a biomarker to assess treatment progress. There is no direct measure of central opioid activity in humans, short of PET scans for opioid receptor binding. However, there is a promising indicator using an opioid antagonist such as naltrexone. Blocking opioid receptor releases the inhibitory opioidergic inputs to hypothalamic corticotropic releasing hormone (CRH) neurons, thus increasing CRH, and eventually cortisol in the blood. The extent of the cortisol rise in response to naltrexone might serve as an indicator of endogenous opioidergic tone. It is hypothesized that greater increases in cortisol indicate weaker endogenous opioid activity (by indicating a more complete opioid blockade). Salivary cortisol response to naltrexone may offer a relatively safe and unobtrusive way to measure endogenous opioidergic tone. We propose to test the reliability and validity of the naltrexone probe, taken at home, as a measure of endogenous opioidergic tone. In a previous study (Daubenmier et al, 2013), we administered a one time 50mg dose of naltrexone and examined nausea and cortisol responses. Results suggested that responses were higher in those who showed greater drive to eat. Here we examine a more direct measure of drive to eat, using the Yale Food Addiction Scale (YFAS), and test whether nausea and cortisol responses were associated with greater drive to eat, whether 50mg produced greater responses than 25 mg, and whether the responses were stable (highly related) when tested again one month later.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women
  • Age > 20 to 45 years (pre-menopausal women)
  • BMI > 30 and no larger than BMI = 40 or 300 pounds

Exclusion Criteria:

  • Inability to provide informed consent or speak English
  • Needle phobic or fainting in response to blood draw
  • Diabetes
  • Currently pregnant or breastfeeding
  • Currently Smoke
  • Bulimia (Binge Eating Disorder is common among the obese, and allowed)
  • Pacemaker
  • Shift Worker
  • Beta Blocker Medication use
  • Liver Medication use
  • Weight Loss Medication use
  • Chronic current use of cortisol containing medications
  • Kidney Disease (based on elevated Blood Urea Nitrogen and Creatinine)
  • Illegal Drug Use (presence in urine)
  • Liver Cirrhosis or Acute hepatitis (based on elevated Alanine transaminase)
  • Substance abuse, mental health, or medical condition that, in the opinion of investigators, will affect study outcomes (e.g., hypertension, severe food allergies).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Naltrexone
4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.
Drug: Naltrexone
4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.
Placebo Comparator: Placebo
4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.
Drug: Placebo
4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ideal Dosage
Time Frame: May 2012
1) To examine criterion validity by testing whether level of opioid tone (based on response to naltrexone probe) is associated with self reported scores on non-homeostatic eating measures, behavioral and cognitive tasks assessing constructs related to addiction (eg, impulsivity) and ideal dosage (25 vs. 50 mg) in 60 obese women.
May 2012

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test Retest Reliability
Time Frame: May 2012
2) To examine test-retest reliability of naltrexone response one month later
May 2012
Home Based Measures Reliability
Time Frame: May 2012
3) To examine the reliability of home based measures. In other words, we will test whether cortisol and nausea responses taken in clinic, which are taken at highly controlled (accurate) times, are comparable to the responses from samples taken at home using saliva measures.
May 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

August 3, 2010

First Posted (Estimate)

August 4, 2010

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1U01HL097973-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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