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Attenuation of Pain in Men and Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by University of Wisconsin, Madison.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220414
First Posted: October 13, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Wisconsin, Madison
  Purpose
The purpose of this study is to examine opioid and endocannabinoid mechanisms of exercise-induced analgesia in men and women.

Condition Intervention
Pain Drug: Naltrexone, Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Attenuation of Pain in Men and Women: Mechanisms of Exercise-Induced Analgesia

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Pain threshold, pain ratings, and temporal summation [ Time Frame: Before and immediately following the two experimental sessions ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Men Drug: Naltrexone,
50 mg of naltrexone
Drug: Placebo
sugar pill
Active Comparator: Women Drug: Naltrexone,
50 mg of naltrexone
Drug: Placebo
sugar pill

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Healthy men and women

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220414


Contacts
Contact: Kelli F Koltyn, PhD 608-262-4234 Koltyn@education.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 52706
Contact: Kelli F Koltyn, Ph.D.    608-262-4234    Koltyn@education.wisc.edu   
Principal Investigator: Kelli F Koltyn, Ph.D.         
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

Responsible Party: Kelli F. Koltyn, University of Wisconsin
ClinicalTrials.gov Identifier: NCT01220414     History of Changes
Other Study ID Numbers: H-2010-0087
First Submitted: September 28, 2010
First Posted: October 13, 2010
Last Update Posted: October 12, 2017
Last Verified: October 2010

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents