Clinical trial NCT02805972: Biology and Experience of Eating in Women With Obesity
Official title: Biology and Experience of Eating in Women With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Obesity
Binge eating
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Number of Participants Who Reported Nausea at 10 Minutes Post Treatment
timeFrame: 10 minutes post-treatment
measure: Number of Participants Who Reported Nausea at 30 Minutes Post Treatment
timeFrame: 30 minutes post-treatment
Secondary outcomes:
measure: Cortisol
timeFrame: 25 minutes post-treatment
measure: Cortisol
timeFrame: 55 minutes post-treatment
measure: Subjective Opiate Withdrawal Scale
timeFrame: 10 minutes post-treatment
measure: Subjective Opiate Withdrawal Scale (Abbreviated)
timeFrame: 30 minutes post-treatment
Other outcomes:
measure: Reward-Driven Eating Scale (RED)
timeFrame: Evaluated before study visit 1
measure: Impulsivity (Delayed Discounting)
timeFrame: Impulsivity was assessed before the study visit 1 intervention.
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ashley E Mason, PhD
role: PRINCIPAL_INVESTIGATOR
References: