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Biology and Experience of Eating (BEE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02805972
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Obesity Drug: Naloxone Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Biology and Experience of Eating
Actual Study Start Date : May 20, 2017
Actual Primary Completion Date : July 25, 2018
Actual Study Completion Date : July 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Naloxone
4 mg / 0.1 ml naloxone
Drug: Naloxone
4 mg / 0.1 ml
Other Name: Narcan

Placebo Comparator: Placebo
0.1 ml saline
Drug: Placebo
0.1 ml
Other Name: saline




Primary Outcome Measures :
  1. Nausea [ Time Frame: 10 minutes post-treatment ]
    Dichotomized response on the Subjective Opiate Withdrawal Scale (SOWS; Gossop, 1990), compared to pre-treatment.

  2. Nausea [ Time Frame: 30 minutes post-treatment ]
    Dichotomized response on the Subjective Opiate Withdrawal Scale (SOWS; Gossop, 1990), compared to pre-treatment.


Secondary Outcome Measures :
  1. Cortisol [ Time Frame: 20 minutes post-treatment ]
    Salivary cortisol level, compared to pre-treatment.

  2. Cortisol [ Time Frame: 50 minutes post-treatment ]
    Salivary cortisol level, compared to pre-treatment. May be combined with the 20 minute measure in a single test for a linear or curvilinear trajectory.

  3. Subjective Opiate Withdrawal Scale (SOWS) [ Time Frame: 10 minutes post-treatment ]
    Total score on the SOWS

  4. Subjective Opiate Withdrawal Scale (SOWS) [ Time Frame: 30 minutes post-treatment ]
    Total score on the SOWS

  5. Reward-driven eating (RED; Epel, Tomiyama, Mason, et al., 2014) [ Time Frame: personality measure assessed pre-treatment ]
    Total score on the RED questionnaire

  6. Impulsivity [ Time Frame: personality measure assessed pre-treatment ]
    Impulsivity (or low executive control) will be measured with a battery of cognitive tasks and likely combined into an aggregate score. The tasks are: Go/No-Go (Fillmore, Rush, & Hays, 2006), Emotional Stroop Task (EST; Smith & Waterman, 2003), N-Back Task (Svaldi et al., 2014), Delayed Discounting (DD; Koffarnus & Bickel, 2014).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese, as defined by BMI greater than or equal to 30
  • Self-reported binge eating as defined in 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805972


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Ashley E Mason, PhD University of California, San Francisco

Additional Information:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02805972     History of Changes
Other Study ID Numbers: 16-19392
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The researchers may share deidentified individual-level data through an open repository, but are not fully decided yet.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
Obesity
Binge eating

Additional relevant MeSH terms:
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Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents