Trial Outcomes & Findings for The Effects of Hydromorphone on Responses to Verbal Tasks (NCT NCT02205983)

Results Overview

The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

End of study (time 0 and approximately 4 weeks later), week 4 reported.

Results posted on

2018-10-09

Participant Flow

Participants were excluded if they had a serious medical condition, abnormal electrocardiogram, Axis I psychiatric disorder in the past year, or a history of psychosis. Subjects were also excluded if they had not completed high school, were not fluent in English, worked a night shift, used hormonal contraceptives, or were pregnant.

Participant milestones

Participant milestones
Measure	2 mg Hydromorphone	4 mg Hydromorphone	1000 mg Acetaminophen	Dextrose (Placebo)
Overall Study STARTED	12	12	13	13
Overall Study COMPLETED	12	12	13	13
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2 mg Hydromophone n=12 Participants Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion.	4 mg Hydromorphone n=12 Participants Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion	1000 mg Acetaminophen n=13 Participants Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.	Dextrose (Placebo) n=13 Participants Healthy adult volunteers will receive Dextrose (placebo).	Total n=50 Participants Total of all reporting groups
Age, Continuous	19.9 years STANDARD_DEVIATION 1.8 • n=5 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	21.2 years STANDARD_DEVIATION 2.8 • n=7 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	23.6 years STANDARD_DEVIATION 6.6 • n=5 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	23.1 years STANDARD_DEVIATION 4.4 • n=4 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	22 years STANDARD_DEVIATION 4.5 • n=21 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.
Sex: Female, Male Female	4 Participants n=5 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	4 Participants n=7 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	6 Participants n=5 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	5 Participants n=4 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	19 Participants n=21 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.
Sex: Female, Male Male	8 Participants n=5 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	8 Participants n=7 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	7 Participants n=5 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	8 Participants n=4 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.	31 Participants n=21 Participants • Row population differs from overall as demographic characteristics of participants is broken down by which group they were randomized into.
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	13 participants n=5 Participants	13 participants n=4 Participants	50 participants n=21 Participants

PRIMARY outcome

Timeframe: End of study (time 0 and approximately 4 weeks later), week 4 reported.

The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4

Outcome measures

Outcome measures
Measure	2 mg Hydromophone n=12 Participants Healthy adult volunteers will receive 2 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion. 2 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.	4 mg Hydromphone n=12 Participants Healthy adult volunteers will receive 4 mg hydromophone. Hydromorphone is a mu-opioid agonist used clinically for pain management. Plasma concentrations of hydromorphone peak approximately 60 min after ingestion 4 mg hydromorphone: We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.	1000 mg Acetaminophen n=13 Participants Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion. 1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.	Dextrose n=13 Participants Healthy adult volunteers will recieve Dextrose (placebo). dextrose: We are administering dextrose to healthy volunteers for our placebo group.
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Feel Drug	7.41 units on a scale Standard Deviation 1.2	14.75 units on a scale Standard Deviation 1.9	28 units on a scale Standard Deviation 1.5	5.76 units on a scale Standard Deviation 1.1
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Like Drug	25.9 units on a scale Standard Deviation 1.8	35.58 units on a scale Standard Deviation 2.5	9.61 units on a scale Standard Deviation 2.2	4.15 units on a scale Standard Deviation 1.4
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Feel High	6.08 units on a scale Standard Deviation 1.5	10.33 units on a scale Standard Deviation 1.01	15 units on a scale Standard Deviation 1.8	2.61 units on a scale Standard Deviation 1.8
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Want More	8.0 units on a scale Standard Deviation 2.1	26.83 units on a scale Standard Deviation 1.5	7.38 units on a scale Standard Deviation 1.96	2.65 units on a scale Standard Deviation 1.5

Adverse Events

2 mg Hydromophone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

4 mg Hydromphone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1000 mg Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dextrose

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

Dr. Harriet de Wit

University of Chicago

Phone: 773-702-3560

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place