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

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naloxone
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Binge eating

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Naloxone, then Placebo

Placebo, then Naloxone

Arm 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)

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)

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Cortisol
Geometric Mean Salivary Cortisol level.
Cortisol
Geometric Mean Salivary Cortisol level.
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.
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).

Full Information

First Posted
June 1, 2016
Last Updated
October 6, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02805972
Brief Title
Biology and Experience of Eating in Women With Obesity
Acronym
BEE
Official Title
Biology and Experience of Eating in Women With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
July 25, 2018 (Actual)
Study Completion Date
July 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Binge eating

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naloxone, then Placebo
Arm Type
Experimental
Arm 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)
Arm Title
Placebo, then Naloxone
Arm Type
Experimental
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Naloxone
Other Intervention Name(s)
Narcan
Intervention Description
4 mg / 0.1 ml
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline
Intervention Description
0.1 ml
Primary Outcome Measure Information:
Title
Number of Participants Who Reported Nausea at 10 Minutes Post Treatment
Description
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.
Time Frame
10 minutes post-treatment
Title
Number of Participants Who Reported Nausea at 30 Minutes Post Treatment
Description
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.
Time Frame
30 minutes post-treatment
Secondary Outcome Measure Information:
Title
Cortisol
Description
Geometric Mean Salivary Cortisol level.
Time Frame
25 minutes post-treatment
Title
Cortisol
Description
Geometric Mean Salivary Cortisol level.
Time Frame
55 minutes post-treatment
Title
Subjective Opiate Withdrawal Scale
Description
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.
Time Frame
10 minutes post-treatment
Title
Subjective Opiate Withdrawal Scale (Abbreviated)
Description
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).
Time Frame
30 minutes post-treatment
Other Pre-specified Outcome Measures:
Title
Reward-Driven Eating Scale (RED)
Description
Reward-Driven Eating Scale (RED) total score ranges from 0 (lower reward-driven eating) to 52 (higher reward-driven eating).
Time Frame
Evaluated before study visit 1
Title
Impulsivity (Delayed Discounting)
Description
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.
Time Frame
Impulsivity was assessed before the study visit 1 intervention.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley E Mason, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Biology and Experience of Eating in Women With Obesity

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