Trial Outcomes & Findings for Sensory and Opioid Mechanisms of Affective Touch (NCT NCT03096353)

NCT ID: NCT03096353

Last Updated: 2021-07-30

Results Overview

Measurement of brushing pleasantness using a visual analogue scale. Sensory hedonics (unpleasantness vs. pleasantness) was assessed on a scale ranging from extremely unpleasant (-100) to neutral (0), to extremely pleasant (100).

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 29 participants
• Primary outcome timeframe: One day, within a 2 hour session
• Results posted on: 2021-07-30

Participant Flow

29 subject consented; one subject consented but did not start either arm of the study

Participant milestones

Measure	Naloxone, Then Placebo Day one - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again. Day two - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.	Placebo, Then Naloxone Day one - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again. Day two - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.
Period 1 STARTED	15	13
Period 1 COMPLETED	12	12
Period 1 NOT COMPLETED	3	1
Period 2 STARTED	12	12
Period 2 COMPLETED	12	12
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sensory and Opioid Mechanisms of Affective Touch

Baseline characteristics by cohort

Measure	Naloxone, Then Placebo n=15 Participants Day one - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again. Day two - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.	Placebo, Then Naloxone n=13 Participants Day one - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again. Day two - During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	11 Participants n=7 Participants	24 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study

Measurement of brushing pleasantness using a visual analogue scale. Sensory hedonics (unpleasantness vs. pleasantness) was assessed on a scale ranging from extremely unpleasant (-100) to neutral (0), to extremely pleasant (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Change in Pleasantness of Skin Brushing From Before to After Infusion	-9.6875 Units on a scale Standard Deviation 21.6314	-4.9583 Units on a scale Standard Deviation 22.3983

SECONDARY outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study

Measurement of pressure pleasantness/unpleasantness using a visual analogue scale. Sensory hedonics (unpleasantness vs. pleasantness) was assessed on a scale ranging from extremely unpleasant (-100) to neutral (0), to extremely pleasant (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Changes in Pleasantness of Deep Skin Pressure From Before to After Infusion	-2.25 Units on a scale Standard Deviation 22.3527	-1.375 Units on a scale Standard Deviation 15.4196

SECONDARY outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study

Measurement of heat pleasantness/unpleasantness using a visual analogue scale. Sensory hedonics (unpleasantness vs. pleasantness) was assessed on a scale ranging from extremely unpleasant (-100) to neutral (0), to extremely pleasant (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Change in Unpleasantness of Cutaneous Heat Pain From Before to After Infusion	-5.75 Units on a scale Standard Deviation 27.2969	-3.4783 Units on a scale Standard Deviation 26.2728

SECONDARY outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study

Measurement of brushing intensity using a visual analogue scale. Intensity was assessed on a scale ranging from no sensation (-100) to pain threshold (0), to intolerable pain (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Changes in Intensity of Skin Brushing From Before to After Infusion	-4.5833 Units on a scale Standard Deviation 12.7511	4.7917 Units on a scale Standard Deviation 23.3065

SECONDARY outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study.

Measurement of pressure intensity using a visual analogue scale. Intensity was assessed on a scale ranging from no sensation (-100) to pain threshold (0), to intolerable pain (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Changes in Intensity of Deep Skin Pressure From Before to After Infusion	-3.8333 Units on a scale Standard Deviation 21.2671	-4 Units on a scale Standard Deviation 20.4762

SECONDARY outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study.

Measurement of heat intensity using a visual analogue scale. Intensity was assessed on a scale ranging from no sensation (-100) to pain threshold (0), to intolerable pain (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Changes in Intensity of Cutaneous Heat Pain From Before to After Infusion	4.4583 Units on a scale Standard Deviation 22.1970	-1.3043 Units on a scale Standard Deviation 24.6092

OTHER_PRE_SPECIFIED outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study.

Functional MRI Blood-oxygen-level-dependent (BOLD) activation in secondary somatosensory cortex (S2) during brushing. BOLD signal is typically expressed as arbitrary units (AU's) measured from "0 to 100% change". 0 being no change and 100% maximum change

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Activation in Somatosensory Cortex (S2) Brain Area of Interest (ROI) During Brushing	0.0475 Arbitrary units Standard Deviation 32.5047	9.6547 Arbitrary units Standard Deviation 31.2841

OTHER_PRE_SPECIFIED outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study.

Functional MRI Blood-oxygen-level-dependent (BOLD) activation in secondary somatosensory cortex (S2) during pressure. BOLD signal is typically expressed as arbitrary units (AU's) measured from "0 to 100% change". 0 being no change and 100% maximum change

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Activation in Somatosensory Cortex (S2) Brain Area of Interest (ROI) During Pressure	-3.1585 Arbitrary units Standard Deviation 42.3639	17.4139 Arbitrary units Standard Deviation 32.5070

OTHER_PRE_SPECIFIED outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study.

Mood during brushing was assessed using a visual analogue scale ranging from extremely bad mood (-100) to neutral mood (0), to extremely good mood (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Changes in Mood During Skin Brushing From Before to After Infusion	-2.375 Units on a scale Standard Deviation 19.0652	1.16667 Units on a scale Standard Deviation 17.5537

OTHER_PRE_SPECIFIED outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study.

Mood during skin pressure was assessed using a visual analogue scale ranging from extremely bad mood (-100) to neutral mood (0), to extremely good mood (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Changes in Mood During Skin Pressure From Before to After Infusion	3.2083 Units on a scale Standard Deviation 20.8287	-1.7917 Units on a scale Standard Deviation 28.6657

OTHER_PRE_SPECIFIED outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study.

Mood during heat was assessed using a visual analogue scale ranging from extremely bad mood (-100) to neutral mood (0), to extremely good mood (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Changes in Mood During Cutaneous Heat From Before to After Infusion	0.3333 Units on a scale Standard Deviation 21.0717	-5.3478 Units on a scale Standard Deviation 20.7476

OTHER_PRE_SPECIFIED outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study.

Anxiety during brushing was assessed using a visual analog scale ranging from extreme anxiety (-100) to neutral (0) to extreme calm (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Changes in Anxiety During Skin Brushing From Before to After Infusion	-2.7917 Units on a scale Standard Deviation 21.8197	-8.5 Units on a scale Standard Deviation 22.4304

OTHER_PRE_SPECIFIED outcome

Timeframe: One day, within a 2 hour session

Population: All participants who completed both the treatment and placebo phases of the study.

Anxiety during pressure was assessed using a visual analog scale ranging from extreme anxiety (-100) to neutral (0) to extreme calm (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Changes in Anxiety During Deep Skin Pressure From Before to After Infusion	0.0417 Units on a scale Standard Deviation 28.3568	-5.9167 Units on a scale Standard Deviation 12.7392

OTHER_PRE_SPECIFIED outcome

Timeframe: One day, within a 2-hour session

Population: All participants who completed both the treatment and placebo phases of the study.

Anxiety during heat was assessed using a visual analog scale ranging from extreme anxiety (-100) to neutral (0) to extreme calm (100).

Outcome measures

Measure	Naloxone n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.	Placebo n=24 Participants During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of normal saline. When infusion levels reached stability, sensory testing was performed again.
Changes in Anxiety During Cutaneous Heat From Before to After Infusion	4.0833 Units on a scale Standard Deviation 22.2583	-12.0435 Units on a scale Standard Deviation 19.3654

Adverse Events

Naloxone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catherine Bushnell

National Center for Complementary and Integrative Health

Phone: +1 301 496 2222

Email: mary.bushnell@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place