Biology and Experience of Eating in Women With Obesity

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

Detailed Description
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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.

Official Title
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Biology and Experience of Eating in Women With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Drug: Naloxone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naloxone, then Placebo<br>4 mg / 0.1 ml Naloxone at visit 1, followed by 0.1 ml saline (Placebo) at visit 2 (with a washout period in between the two visits) | Drug: Naloxone<br>* 4 mg / 0.1 ml<br>* Other names: Narcan;Drug: Placebo<br>* 0.1 ml<br>* Other names: saline;|
| Experimental: Placebo, then Naloxone<br>0.1 ml saline (Placebo) at visit 1, followed by 4 mg / 0.1 ml Naloxone at visit 2 (with a washout period in between the two visits) | Drug: Naloxone<br>* 4 mg / 0.1 ml<br>* Other names: Narcan;Drug: Placebo<br>* 0.1 ml<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Reported Nausea at 10 Minutes Post Treatment | Dichotomized response on the I feel nauseous question of the Subjective Opiate Withdrawal Scale, at 10 minutes after the listed intervention (among participants who completed both intervention visits). Response 0 = absence of nausea, 1 = presence of nausea. | 10 minutes post-treatment | 
| Number of Participants Who Reported Nausea at 30 Minutes Post Treatment | Dichotomized response on the I feel nauseous question of the Subjective Opiate Withdrawal Scale, at 30 minutes after the listed intervention (among participants who completed both intervention visits). Response 0 = absence of nausea, 1 = presence of nausea. | 30 minutes post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol | Geometric Mean Salivary Cortisol level. | 25 minutes post-treatment | 
| Cortisol | Geometric Mean Salivary Cortisol level. | 55 minutes post-treatment | 
| Subjective Opiate Withdrawal Scale | Summed score of Subjective Opiate Withdrawal Scale (SOWS). Scale consists of 16 items answered on a 5 point numeric rating scale. Score range is 0 (lesser withdrawal symptoms) to 64 (greater withdrawal symptoms). Scores were assessed at 10 minutes after Naloxone, and at a separate visit, 10 minutes after Placebo, among participants who completed both study visits. | 10 minutes post-treatment | 
| Subjective Opiate Withdrawal Scale (Abbreviated) | Mean score on subset of 5 items (which used a 5 point numeric rating response scale) from the Subjective Opiate Withdrawal Scale (SOWS). This summed score can range from 0 (corresponding to lesser withdrawal symptoms) to 20 (corresponding to greater withdrawal symptoms). | 30 minutes post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Binge eating