Biology and Experience of Eating



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 45
Updated:8/1/2018
Start Date:May 20, 2017
End Date:July 25, 2018

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

Obesity is associated with greater risk for cardiovascular disease (CVD), stroke, diabetes,
and mortality, and is a heterogeneous condition with various causes and thus a diversity of
intervention targets. Compulsive overeating afflicts 30% of people seeking obesity treatment
and increases risk for CVD factors. This trial involves two participant visits to test
whether opioid blockade (Day 1 or 2, depending on randomization), compared to placebo (Day 1
or 2, depending on randomization), will elicit common symptoms of opioid withdrawal,
including nausea. Participants will receive each condition on separate days.

Inclusion Criteria:

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

- Self-reported binge eating as defined in 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
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Ashley E Mason, PhD
Phone: 415-476-7634
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mi
from
San Francisco, CA
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