Obesity Clinical Trial
— BEEOfficial title:
Biology and Experience of Eating in Women With Obesity
NCT number | NCT02805972 |
Other study ID # | 16-19392 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 20, 2017 |
Est. completion date | July 25, 2018 |
Verified date | October 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to understand how the opioid system is involved in eating behavior.
Status | Completed |
Enrollment | 41 |
Est. completion date | July 25, 2018 |
Est. primary completion date | July 25, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Reward-Driven Eating Scale (RED) | Reward-Driven Eating Scale (RED) total score ranges from 0 (lower reward-driven eating) to 52 (higher reward-driven eating). | Evaluated before study visit 1 | |
Other | Impulsivity (Delayed Discounting) | Impulsivity, measured by the Delayed Discounting cognitive task, based on a series of 30 computer-administered trials or questions. Indifference points (a measure of how much a person values a delayed reward) are determined for time delays of: 1 day, 7 days, 30 days, 180 days, and 365 days, and these are used to calculate an Area Under the Curve which ranges from 0 to 1 (lower numbers indicate higher impulsivity) as a metric of probability. | Impulsivity was assessed before the study visit 1 intervention. | |
Primary | 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 | |
Primary | 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 | Cortisol | Geometric Mean Salivary Cortisol level. | 25 minutes post-treatment | |
Secondary | Cortisol | Geometric Mean Salivary Cortisol level. | 55 minutes post-treatment | |
Secondary | Subjective Opiate Withdrawal Scale | Summed score of Subjective Opiate Withdrawal Scale (SOWS). Scale consists of 16 items answered on a 5 point numeric rating scale. Score range is 0 (lesser withdrawal symptoms) to 64 (greater withdrawal symptoms). Scores were assessed at 10 minutes after Naloxone, and at a separate visit, 10 minutes after Placebo, among participants who completed both study visits. | 10 minutes post-treatment | |
Secondary | Subjective Opiate Withdrawal Scale (Abbreviated) | Mean score on subset of 5 items (which used a 5 point numeric rating response scale) from the Subjective Opiate Withdrawal Scale (SOWS). This summed score can range from 0 (corresponding to lesser withdrawal symptoms) to 20 (corresponding to greater withdrawal symptoms). | 30 minutes post-treatment |
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