Phase 2 N=41 Randomized Quadruple-blind Basic Science

Biology and Experience of Eating in Women With Obesity

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02805972 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcome: Primary: Number of Participants Who Reported Nausea at 10 Minutes Post Treatment — 17; 18 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Naloxone (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of California, San Francisco
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Reported Nausea at 10 Minutes Post Treatment	17; 18	—
PRIMARY Number of Participants Who Reported Nausea at 30 Minutes Post Treatment	13; 11	—
SECONDARY Cortisol	3.61; 2.90	.067
SECONDARY Cortisol	3.61; 2.90	.067
SECONDARY Subjective Opiate Withdrawal Scale	5.67; 5.03	—
SECONDARY Subjective Opiate Withdrawal Scale (Abbreviated)	1.42; 1.53	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02805972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.