At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 41 enrolled
Drug / intervention
Naloxone +1 moredrug
Likely dose
Naloxone 4 mg intranasal, dose frequency not specifiedAI-extracted
Key inclusion· 4
- ✓BMI ≥30 (obese)
- ✓Self-reported binge eating meeting DSM-5 criteria in last 4 weeks
- ✓If sexually active with men, must agree to contraception through final study visit
- ✓Able to provide informed consent and comply with study requirements
Key exclusion· 10
- ✕Pregnant or breastfeeding
- ✕Severe hypotension (<90/60 mmHg)
- ✕Current or recent use of vasoconstrictor or vasodilator medications
- ✕Current or history of diabetes
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Biology and Experience of Eating in Women With Obesity
In Brief
A Phase 2 clinical trial evaluating Naloxone and Placebo for Obesity. Completed, enrolled 41 participants across 1 site.
Detailed Summary
The purpose of this study is to understand how the opioid system is involved in eating behavior.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartMay 2017
Primary CompletionJul 2018
TodayJul 2026
First PostedJun 20, 2016
Enrollment StartMay 20, 2017
Primary CompletionJul 25, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.0 years ago
Interventions
Naloxonedrug
4 mg / 0.1 ml
Placebodrug
0.1 ml