SHE: Stress, Hormones, and Eating

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01175512

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Food Addiction How Opioid Tone Was Related to Self Reported Drive to Eat Using a Measure of Food Addiction	Drug: Naltrexone Drug: Placebo	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Novel Interventions to Reduce Stress Induced Non-homeostatic Eating

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Ideal Dosage [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.

Secondary Outcome Measures

Test Retest Reliability [May 2012]
2) To examine test-retest reliability of naltrexone response one month later
Home Based Measures Reliability [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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).