Biology and Experience of Eating in Women With Obesity

• Status: Completed
• Trial end date: 2018-07-25
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to understand how the opioid system is involved in eating behavior.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Naloxone

Criteria

Inclusion Criteria:

• Obese, as defined by BMI greater than or equal to 30

• Self-reported binge eating as defined in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), in the last 4 weeks

• If sexually active with men, must agree to use birth control until the final study visit is complete (e.g., barrier methods, oral contraceptive)

• Subject must be able to complete written informed consent procedures and be able to comply with the requirements of the study.

Exclusion Criteria:

• Pregnant or breastfeeding

• Severe hypotension (< 90/60 mmHg)

• Recent or current use of vasoconstrictor or vasodilator medication

• Current or history of diabetes

• Allergies to any ingredients in naloxone hydrochloride

• History of or current alcoholism or drug dependence

• Bulimia Nervosa as defined in DSM 5

• Current or past use of opiate-containing medications in the last 30 days

• Plan to use opiate-containing medications during study participation period

• Medical conditions that are contraindicated with intranasal procedures: Nasal septal abnormalities, nasal trauma, epistaxis, excessive nasal mucus, and intranasal damage caused by the use of substances (e.g., cocaine)

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data