Biology and Experience of Eating in Women With Obesity

NCT ID: NCT02805972

Last Updated: 2021-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-20
• Study Completion Date: 2018-07-25

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.

Conditions

Obesity

Keywords

Obesity; Binge eating

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Naloxone

Intervention Type: DRUG

4 mg / 0.1 ml

Placebo

Intervention Type: DRUG

0.1 ml

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)

Group Type: EXPERIMENTAL

Naloxone

Intervention Type: DRUG

4 mg / 0.1 ml

Placebo

Intervention Type: DRUG

0.1 ml

Interventions

Naloxone

4 mg / 0.1 ml

Intervention Type: DRUG

Placebo

0.1 ml

Intervention Type: DRUG

Other Intervention Names

Narcan; saline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley E Mason, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

16-19392

Identifier Type: -

Identifier Source: org_study_id