Trial Outcomes & Findings for Attenuation of Pain in Men and Women (NCT NCT01220414)

Last Updated: 2018-02-19

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Baseline

Results posted on

2018-02-19

Participant milestones
Measure	Males, Naltrexone Then Placebo	Males, Placebo Then Naltrexone	Females, Naltrexone Then Placebo	Females, Placebo Then Naltrexone
Overall Study STARTED	15	14	14	15
Overall Study COMPLETED	14	14	14	14
Overall Study NOT COMPLETED	1	0	0	1

Reasons for withdrawal
Measure	Males, Naltrexone Then Placebo	Males, Placebo Then Naltrexone	Females, Naltrexone Then Placebo	Females, Placebo Then Naltrexone
Overall Study Withdrawal by Subject	1	0	0	1

Attenuation of Pain in Men and Women

Baseline characteristics by cohort
Measure	Naltrexone Then Placebo n=29 Participants All participants completed both naltrexone and placebo conditions	Placebo Then Naltrxone n=29 Participants	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=93 Participants	29 Participants n=4 Participants	58 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	21 years STANDARD_DEVIATION 3 • n=93 Participants	21 years STANDARD_DEVIATION 3 • n=4 Participants	21 years STANDARD_DEVIATION 3 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	15 Participants n=4 Participants	29 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants
Region of Enrollment United States	29 participants n=93 Participants	29 participants n=4 Participants	58 participants n=27 Participants

Timeframe: Baseline

Outcome measures
Measure	Men, Placebo n=14 Participants	Women, Placebo n=15 Participants	Men, Naltrexone n=15 Participants	Females, Naltrexone n=14 Participants
Time for Subject to Reach Pain Threshold Pain threshold at baseline	16.1 seconds Standard Deviation 12.1	16.0 seconds Standard Deviation 24.0	15.0 seconds Standard Deviation 10.0	14.8 seconds Standard Deviation 24.0
Time for Subject to Reach Pain Threshold Pain threshold post exercise	28.8 seconds Standard Deviation 27.6	24.1 seconds Standard Deviation 35.3	28.4 seconds Standard Deviation 26.6	22.5 seconds Standard Deviation 30.1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Wisconsin-Madison

Phone: 608 262-4234