Stress, Hormones, and Eating (SHE)
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01175512
First received: July 28, 2010
Last updated: December 5, 2011
Last verified: December 2011
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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.
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175512
Locations
| United States, California | |
| University California San Francisco | |
| San Francisco, California, United States, 94118 | |
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: | December 5, 2011 |
| 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 May 19, 2013