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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 : Completed
First Posted : October 13, 2010
Results First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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, then placebo Drug: Placebo, then Naltrexone

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover 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
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Men Drug: Naltrexone, then placebo
50 mg of naltrexone
Drug: Placebo, then Naltrexone
sugar pill
Active Comparator: Women Drug: Naltrexone, then placebo
50 mg of naltrexone
Drug: Placebo, then Naltrexone
sugar pill



Primary Outcome Measures :
  1. Time for Subject to Reach Pain Threshold [ Time Frame: Baseline ]


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
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

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


Locations
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 52706
Sponsors and Collaborators
University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01220414     History of Changes
Other Study ID Numbers: H-2010-0087
First Posted: October 13, 2010    Key Record Dates
Results First Posted: February 16, 2018
Last Update Posted: February 16, 2018
Last Verified: January 2018

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