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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Naloxone; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naloxone, then Placebo; 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; 4 mg / 0.1 ml; Other Names: Narcan; Drug: Placebo; 0.1 ml; Other Names: saline
Experimental: Placebo, then Naloxone; 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; 4 mg / 0.1 ml; Other Names: Narcan; Drug: Placebo; 0.1 ml; Other Names: saline

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reward-Driven Eating Scale (RED)	Reward-Driven Eating Scale (RED) total score ranges from 0 (lower reward-driven eating) to 52 (higher reward-driven eating).	Evaluated before study visit 1
Impulsivity (Delayed Discounting)	Impulsivity, measured by the Delayed Discounting cognitive task, based on a series of 30 computer-administered trials or questions. Indifference points (a measure of how much a person values a delayed reward) are determined for time delays of: 1 day, 7 days, 30 days, 180 days, and 365 days, and these are used to calculate an Area Under the Curve which ranges from 0 to 1 (lower numbers indicate higher impulsivity) as a metric of probability.	Impulsivity was assessed before the study visit 1 intervention.

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2017
• Primary Completion (Actual): July 25, 2018
• Study Completion (Actual): July 25, 2018

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Binge eating
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxone
• Other Study ID Numbers: 16-19392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No