Stress, Hormones, and Eating

NCT01175512 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 1U01HL097973-01
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Food Addiction; How Opioid Tone Was Related to Self Reported; Drive to Eat Using a Measure of Food Addiction

Keywords

naltrexone; obesity; cortisol; food addiction

Outcome Measures

Primary Outcomes (1)

• Ideal Dosage

  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 Outcomes (2)

• Test Retest Reliability

  May 2012

• Home Based Measures Reliability

  May 2012

Study Arms (2)

Naltrexone

ACTIVE COMPARATOR

4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.

Drug: Naltrexone

Placebo

PLACEBO COMPARATOR

4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.

Drug: Placebo

Interventions

Naltrexone DRUG

4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.

Naltrexone

Placebo DRUG

4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Related Publications (2)

• Gearhardt AN, Corbin WR, Brownell KD. Preliminary validation of the Yale Food Addiction Scale. Appetite. 2009 Apr;52(2):430-6. doi: 10.1016/j.appet.2008.12.003. Epub 2008 Dec 11.

  PMID: 19121351 BACKGROUND

• Daubenmier J, Lustig RH, Hecht FM, Kristeller J, Woolley J, Adam T, Dallman M, Epel E. A new biomarker of hedonic eating? A preliminary investigation of cortisol and nausea responses to acute opioid blockade. Appetite. 2014 Mar;74:92-100. doi: 10.1016/j.appet.2013.11.014. Epub 2013 Nov 27.

  PMID: 24291355 BACKGROUND

MeSH Terms

Conditions

Food Addiction; Obesity

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Feeding and Eating Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Elissa Epel, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: August 4, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 28, 2021

Record last verified: 2021-01