Biology and Experience of Eating in Women With Obesity

NCT02805972 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 16-19392
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity; Binge eating

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Cortisol

  25 minutes post-treatment

• Cortisol

  55 minutes post-treatment

• Subjective Opiate Withdrawal Scale

  10 minutes post-treatment

• Subjective Opiate Withdrawal Scale (Abbreviated)

  30 minutes post-treatment

Other Outcomes (2)

• Reward-Driven Eating Scale (RED)

  Evaluated before study visit 1

• Impulsivity (Delayed Discounting)

  Impulsivity was assessed before the study visit 1 intervention.

Study Arms (2)

Naloxone, then Placebo

EXPERIMENTAL

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; Drug: Placebo

Placebo, then Naloxone

EXPERIMENTAL

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; Drug: Placebo

Interventions

Naloxone DRUG

4 mg / 0.1 ml

Also known as: Narcan

Naloxone, then Placebo; Placebo, then Naloxone

Placebo DRUG

0.1 ml

Also known as: saline

Naloxone, then Placebo; Placebo, then Naloxone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Obesity; Bulimia

Interventions

Naloxone; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Ashley Mason, PhD
• Organization: University of California San Francisco

ashley.mason@ucsf.edu

415 514 6820

Study Officials

• Ashley E Mason, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 20, 2016
• Study Start: May 20, 2017
• Primary Completion: July 25, 2018
• Study Completion: July 25, 2018
• Last Updated: November 3, 2021
• Results First Posted: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)