Trial Outcomes & Findings for Biology and Experience of Eating in Women With Obesity (NCT NCT02805972)
NCT ID: NCT02805972
Last Updated: 2021-11-03
Results Overview
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.
COMPLETED
PHASE2
41 participants
10 minutes post-treatment
2021-11-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Intervention Visit 1
STARTED
|
23
|
18
|
|
Intervention Visit 1
COMPLETED
|
23
|
18
|
|
Intervention Visit 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period
STARTED
|
23
|
18
|
|
Washout Period
COMPLETED
|
20
|
18
|
|
Washout Period
NOT COMPLETED
|
3
|
0
|
|
Intervention Visit 2
STARTED
|
20
|
18
|
|
Intervention Visit 2
COMPLETED
|
20
|
18
|
|
Intervention Visit 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Washout Period
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Biology and Experience of Eating in Women With Obesity
Baseline characteristics by cohort
| Measure |
Naloxone, Then Placebo
n=23 Participants
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.
|
Placebo, Then Naloxone
n=18 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Weight, kg
|
104.3 kilograms
STANDARD_DEVIATION 23.9 • n=5 Participants
|
99.5 kilograms
STANDARD_DEVIATION 17.0 • n=7 Participants
|
102.2 kilograms
STANDARD_DEVIATION 21.1 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
38.1 kg/m^2
STANDARD_DEVIATION 7.1 • n=5 Participants
|
36.4 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
37.3 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Impulsivity
|
0.69 Probability
STANDARD_DEVIATION 0.21 • n=5 Participants
|
0.57 Probability
STANDARD_DEVIATION 0.29 • n=7 Participants
|
0.64 Probability
STANDARD_DEVIATION 0.25 • n=5 Participants
|
|
Reward-driven Eating (RED) scale
|
38.1 units on a scale
STANDARD_DEVIATION 6.1 • n=5 Participants
|
36.8 units on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
37.5 units on a scale
STANDARD_DEVIATION 5.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutes post-treatmentPopulation: All participants who received Naloxone, then Placebo, or Placebo, then Naloxone, by participating in both study intervention visits.
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.
Outcome measures
| Measure |
Naloxone
n=38 Participants
4 mg / 0.1 ml naloxone
Naloxone: 4 mg / 0.1 ml
|
Placebo
n=38 Participants
0.1 ml saline
Placebo: 0.1 ml
|
|---|---|---|
|
Number of Participants Who Reported Nausea at 10 Minutes Post Treatment
|
17 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 30 minutes post-treatmentPopulation: All participants who received Naloxone, then Placebo, or Placebo, then Naloxone, by participating in both study intervention visits.
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.
Outcome measures
| Measure |
Naloxone
n=38 Participants
4 mg / 0.1 ml naloxone
Naloxone: 4 mg / 0.1 ml
|
Placebo
n=38 Participants
0.1 ml saline
Placebo: 0.1 ml
|
|---|---|---|
|
Number of Participants Who Reported Nausea at 30 Minutes Post Treatment
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 25 minutes post-treatmentPopulation: Participants 25 minutes after Naloxone or Placebo administration, among those who completed both intervention visits
Geometric Mean Salivary Cortisol level.
Outcome measures
| Measure |
Naloxone
n=38 Participants
4 mg / 0.1 ml naloxone
Naloxone: 4 mg / 0.1 ml
|
Placebo
n=38 Participants
0.1 ml saline
Placebo: 0.1 ml
|
|---|---|---|
|
Cortisol
|
3.22 nmol/L
Standard Deviation 2.18
|
3.37 nmol/L
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: 55 minutes post-treatmentPopulation: Participants 55 minutes after Naloxone or Placebo administration, among those who completed both intervention visits
Geometric Mean Salivary Cortisol level.
Outcome measures
| Measure |
Naloxone
n=38 Participants
4 mg / 0.1 ml naloxone
Naloxone: 4 mg / 0.1 ml
|
Placebo
n=38 Participants
0.1 ml saline
Placebo: 0.1 ml
|
|---|---|---|
|
Cortisol
|
3.61 nmol/L
Standard Deviation 2.26
|
2.90 nmol/L
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: 10 minutes post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Naloxone
n=38 Participants
4 mg / 0.1 ml naloxone
Naloxone: 4 mg / 0.1 ml
|
Placebo
n=38 Participants
0.1 ml saline
Placebo: 0.1 ml
|
|---|---|---|
|
Subjective Opiate Withdrawal Scale
|
5.67 score on a scale
Standard Deviation 3.65
|
5.03 score on a scale
Standard Deviation 3.58
|
SECONDARY outcome
Timeframe: 30 minutes post-treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Naloxone
n=38 Participants
4 mg / 0.1 ml naloxone
Naloxone: 4 mg / 0.1 ml
|
Placebo
n=38 Participants
0.1 ml saline
Placebo: 0.1 ml
|
|---|---|---|
|
Subjective Opiate Withdrawal Scale (Abbreviated)
|
1.42 score on a scale
Standard Deviation 1.35
|
1.53 score on a scale
Standard Deviation 1.50
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Evaluated before study visit 1Population: All eligible participants who were randomized to either order of intervention conditions.
Reward-Driven Eating Scale (RED) total score ranges from 0 (lower reward-driven eating) to 52 (higher reward-driven eating).
Outcome measures
| Measure |
Naloxone
n=23 Participants
4 mg / 0.1 ml naloxone
Naloxone: 4 mg / 0.1 ml
|
Placebo
n=18 Participants
0.1 ml saline
Placebo: 0.1 ml
|
|---|---|---|
|
Reward-Driven Eating Scale (RED)
|
38.1 score on a scale
Standard Deviation 6.1
|
36.8 score on a scale
Standard Deviation 5.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Impulsivity was assessed before the study visit 1 intervention.Population: All eligible participants randomized to either order of the intervention.
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.
Outcome measures
| Measure |
Naloxone
n=23 Participants
4 mg / 0.1 ml naloxone
Naloxone: 4 mg / 0.1 ml
|
Placebo
n=18 Participants
0.1 ml saline
Placebo: 0.1 ml
|
|---|---|---|
|
Impulsivity (Delayed Discounting)
|
0.69 Probability
Standard Deviation 0.21
|
0.57 Probability
Standard Deviation 0.29
|
Adverse Events
Naloxone, Then Placebo
Placebo, Then Naloxone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ashley Mason, PhD
University of California San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place