NCT01220414

Brief Summary

The purpose of this study is to examine opioid and endocannabinoid mechanisms of exercise-induced analgesia in men and women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

February 19, 2018

Completed
Last Updated

February 19, 2018

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

September 28, 2010

Results QC Date

December 7, 2015

Last Update Submit

January 22, 2018

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Time for Subject to Reach Pain Threshold

    Baseline

Study Arms (2)

Men

ACTIVE COMPARATOR
Drug: Naltrexone, then placeboDrug: Placebo, then Naltrexone

Women

ACTIVE COMPARATOR
Drug: Naltrexone, then placeboDrug: Placebo, then Naltrexone

Interventions

Naltrexone, then placeboDRUG

50 mg of naltrexone

MenWomen
Placebo, then NaltrexoneDRUG

sugar pill

MenWomen

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • current cardiac or other chronic diseases (e.g., cancer, diabetes, hypertension, kidney disease); routine use of prescriptive medications; history of vasovagal response to phlebotomy; an allergy to naltrexone; pregnancy; current smokers; current use of recreational drugs; history of substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 52706, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Kelli F. Koltyn
Organization
University of Wisconsin-Madison
kelli.koltyn@wisc.edu
608 262-4234

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2010

First Posted

October 13, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 19, 2018

Results First Posted

February 19, 2018

Record last verified: 2018-01

Locations

US(1)