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The purpose of this study is to understand how the opioid system is involved in eating behavior.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naloxone, then Placebo | Experimental | 4 mg / 0.1 ml Naloxone at visit 1, followed by 0.1 ml saline (Placebo) at visit 2 (with a washout period in between the two visits) |
|
| Placebo, then Naloxone | Experimental | 0.1 ml saline (Placebo) at visit 1, followed by 4 mg / 0.1 ml Naloxone at visit 2 (with a washout period in between the two visits) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxone | Drug | 4 mg / 0.1 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol | Geometric Mean Salivary Cortisol level. | 25 minutes post-treatment |
| Cortisol | Geometric Mean Salivary Cortisol level. | 55 minutes post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Impulsivity (Delayed Discounting) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley E Mason, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Naloxone, Then Placebo | At the first intervention visit, participants were administered Naloxone, 4 mg / 0.1 ml, intranasally, after eating. After the washout period, at the second intervention visit, participants were administered the Placebo (saline), 0.1 ml, intranasally, after eating. |
| FG001 | Experimental: Placebo, Then Naloxone | At the first intervention visit, participants were administered the Placebo (saline), 0.1 ml, intranasally, after eating. After the washout period, at the second intervention visit, participants were administered Naloxone, 4 mg / 0.1 ml, intranasally, after eating. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Visit 1 |
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| Washout Period |
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| Intervention Visit 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Naloxone, Then Placebo | At visit 1, participants were administered Naloxone, 4 mg/ 0.1 ml, intranasally, after eating. After the washout period between visits, at visit 2, participants were administered the Placebo (saline), 0.1 ml, intranasally, after eating. |
| BG001 | Placebo, Then Naloxone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received Naloxone, then Placebo, or Placebo, then Naloxone, by participating in both study intervention visits. | Posted | Count of Participants | Participants | 10 minutes post-treatment |
|
Two days (each study intervention visit was conducted over approximately 4 hours, with the 2 interventions administered on a total of 2 separate visit days).
The definition used did not differ from that of clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naloxone, Then Placebo | Visit 1 intervention condition: 4 mg / 0.1 ml Naloxone, followed by visit 2 condition: 0.1 ml Placebo (saline) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashley Mason, PhD | University of California San Francisco | 415 514 6820 | ashley.mason@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2017 | Jul 8, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2017 | Jul 8, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D009270 | Naloxone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | 0.1 ml |
|
|
| 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 |
| 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 |
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. |
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At visit 1, participants were administered the Placebo (saline), 0.1 ml, intranasally, after eating. After the washout period between visits, at visit 2, participants were administered Naloxone, 4 mg/ 0.1 ml, intranasally, after eating. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight, kg | Participants were weighted two times at baseline and the average of two measures was used (weight in kilograms). | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (BMI) | Body mass index (BMI) was calculated from the mean of duplicate weight measurements, and the height measurement, at baseline. BMI units are kilograms per meter squared (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Impulsivity | 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. | Mean | Standard Deviation | Probability |
|
| Reward-driven Eating (RED) scale | Total score ranges from 0 (lower reward-driven eating) to 52 (higher reward-driven eating). | Mean | Standard Deviation | units on a scale |
|
0.1 ml saline
Placebo: 0.1 ml
|
|
| 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. | All participants who received Naloxone, then Placebo, or Placebo, then Naloxone, by participating in both study intervention visits. | Posted | Count of Participants | Participants | 30 minutes post-treatment |
|
|
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| Secondary | Cortisol | Geometric Mean Salivary Cortisol level. | Participants 25 minutes after Naloxone or Placebo administration, among those who completed both intervention visits | Posted | Geometric Mean | Standard Deviation | nmol/L | 25 minutes post-treatment |
|
|
|
| Secondary | Cortisol | Geometric Mean Salivary Cortisol level. | Participants 55 minutes after Naloxone or Placebo administration, among those who completed both intervention visits | Posted | Geometric Mean | Standard Deviation | nmol/L | 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. | Measurement of Subjective Opiate Withdrawal Scale here reported 10 min post Naloxone or 10 minutes after Placebo, among all participants who received Naloxone (4mg / 0.1 ml), then after a washout period, received Placebo (saline, 0.1 ml), or Placebo, then after a washout period, received Naloxone, by participating in both study intervention visits. | Posted | Mean | Standard Deviation | score on a scale | 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). | Measurement of the abbreviated SOWS here reported 30 min post Naloxone or 30 min post Placebo, among all participants who received Naloxone (4mg / 0.1 ml), then after a washout period, received Placebo (saline, 0.1 ml), or Placebo, then after a washout period, received Naloxone, by participating in both study intervention visits. | Posted | Mean | Standard Deviation | score on a scale | 30 minutes post-treatment |
|
|
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| Other Pre-specified | 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). | All eligible participants who were randomized to either order of intervention conditions. | Posted | Mean | Standard Deviation | score on a scale | Evaluated before study visit 1 |
|
|
|
| Other Pre-specified | 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. | All eligible participants randomized to either order of the intervention. | Posted | Mean | Standard Deviation | Probability | Impulsivity was assessed before the study visit 1 intervention. |
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Placebo, Then Naloxone | Visit 1 intervention condition: 0.1 ml Placebo (saline), followed by visit 2 condition: 4 mg / 0.1 ml Naloxone | 0 | 18 | 0 | 18 | 0 | 18 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
The null hypothesis is that there would be no difference across the Naloxone and placebo conditions. The alternative hypothesis is that the cortisol value would be higher in the Naloxone condition than in the placebo condition. |