Phase 2
Completed N=41
Biology and Experience of Eating in Women With Obesity
Source: ClinicalTrials.gov NCT02805972 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Number of Participants Who Reported Nausea at 10 Minutes Post Treatment — 17; 18 Participants
Summary
The purpose of this study is to understand how the opioid system is involved in eating behavior.
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 Subjective Opiate Withdrawal Scale |
5.67; 5.03 | — |
| SECONDARY Subjective Opiate Withdrawal Scale (Abbreviated) |
1.42; 1.53 | — |
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
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. Informational only — not medical advice.