Hormone Function in Men Treated for Pain With Opioids or Placebo

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier:
NCT00737737
First received: August 16, 2008
Last updated: April 9, 2015
Last verified: April 2015
Results First Received: April 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Chronic Pain
Osteoarthritis
Interventions: Drug: MS Contin
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled patients with osteoarthritis at the National Institutes of Health Clinical Center. The last patient completed the study in 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 8 patients were enrolled in the study. Three patients did not qualify for the study, 1 patient elected to withdraw from the study to undergo joint surgery prior to receiving study drug and 4 patients completed the study.

Reporting Groups
  Description
Opioid

Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg

MS Contin

Placebo Participants will receive a similar number of matched placebo tablets over a period of 4 weeks

Participant Flow:   Overall Study
    Opioid     Placebo  
STARTED     2     2  
COMPLETED     2     2  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Opioid

Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg

MS Contin

Placebo Participants will receive a similar number of matched placebo tablets over a period of 4 weeks
Total Total of all reporting groups

Baseline Measures
    Opioid     Placebo     Total  
Number of Participants  
[units: participants]
  2     2     4  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     2     4  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     2     2     4  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     2     1     3  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     2     2     4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Is Chronic Opioid Treatment Associated With Changes in Adrenocorticotropic Hormone (ACTH), Cortisol, Luteinizing Hormone (LH) and Testosterone Secretion?   [ Time Frame: 4 weeks ]

2.  Secondary:   Is Placebo Analgesia Associated With a Similar Hormonal Response as Elicited by an Opioid Analgesic?   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrew Mannes, M.D.
Organization: National Institutes of Health Clinical Center
phone: 301-594-3427
e-mail: Andrew.Mannes@nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Nursing Research (NINR) )
ClinicalTrials.gov Identifier: NCT00737737     History of Changes
Other Study ID Numbers: 080190, 08-NR-0190
Study First Received: August 16, 2008
Results First Received: April 9, 2015
Last Updated: April 9, 2015
Health Authority: United States: Federal Government