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Stress, Hormones, and Eating (SHE)

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ClinicalTrials.gov Identifier: NCT01175512
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : October 9, 2013
Sponsor:
Information provided by (Responsible Party):

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
Food Addiction Drug: Naltrexone

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Novel Interventions to Reduce Stress Induced Non-homeostatic Eating
Study Start Date : July 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Test Retest Reliability [ Time Frame: May 2012 ]
    2) To examine test-retest reliability of naltrexone response one month later

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175512


Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Elissa Epel, PhD University of California, San Francisco
More Information

Additional Information:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01175512     History of Changes
Other Study ID Numbers: 1U01HL097973-01 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents