Biology and Experience of Eating in Women With Obesity (BEE)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: Naloxone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02805972

16-19392

Details and patient eligibility

About

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

Full description

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.

Enrollment: 41 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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41 participants in 2 patient groups

Naloxone, then Placebo

Experimental group

Description:

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)

Treatment:

Drug: Placebo

Drug: Naloxone

Placebo, then Naloxone

Experimental group

Description:

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)

Treatment:

Drug: Placebo

Drug: Naloxone