Stress, Hormones, and Eating (SHE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01175512
First received: July 28, 2010
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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 Intervention
Food Addiction
Drug: Naltrexone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Novel Interventions to Reduce Stress Induced Non-homeostatic Eating

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Ideal Dosage [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
    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 [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
    2) To examine test-retest reliability of naltrexone response one month later

  • Home Based Measures Reliability [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
    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.


Enrollment: 44
Study Start Date: July 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175512

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

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01175512     History of Changes
Other Study ID Numbers: 1U01HL097973-01
Study First Received: July 28, 2010
Last Updated: October 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014