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Attenuation of Pain in Men and Women

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.
ClinicalTrials.gov Identifier: NCT01220414
Recruitment Status : Unknown
Verified October 2010 by University of Wisconsin, Madison.
Recruitment status was:  Recruiting
First Posted : October 13, 2010
Last Update Posted : October 18, 2010
Information provided by:

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

Condition or disease Intervention/treatment
Pain Drug: Naltrexone, Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : September 2010
Estimated Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

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

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 Posted: October 13, 2010    Key Record Dates
Last Update Posted: October 18, 2010
Last Verified: October 2010

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