Effects of Low Dose Naltrexone in Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
American Fibromyalgia Syndrome Association
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT00568555
First received: December 4, 2007
Last updated: September 21, 2015
Last verified: September 2015
Results First Received: April 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Fibromyalgia
Persian Gulf Syndrome
Interventions: Drug: Low Dose Naltrexone
Drug: Placebo - sugar pill

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
325 women completed an online web survey

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Individuals were assessed for eligibility via web screening and phone screening prior to enrollment.

Further eligibility (blood tests, questionnaires) assessed after enrollment; ineligible consented participants were withdrawn prior to assignment to groups.


Reporting Groups
  Description
Low Dose Naltrexone First Low Dose Naltrexone (LDN) followed by placebo. LDN at 3-4.5mg, once a day. Placebo (sugar pill) once a day.
Placebo - Sugar Pill First Placebo first, followed by LDN. Placebo (sugar pill) once a day. LDN at 3-4.5mg, once a day.

Participant Flow:   Overall Study
    Low Dose Naltrexone First     Placebo - Sugar Pill First  
STARTED     16     15  
COMPLETED     15     14  
NOT COMPLETED     1     1  
Withdrawal by Subject                 1                 1  



  Baseline Characteristics
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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.

2 participants in the low dose naltrexone group did not have data to analyze (1 withdrew by patient choice, 1 had a malfunction with the data collection device)

1 participant in the placebo condition did not have data to analyze (withdrew by patient choice)


Reporting Groups
  Description
Low Dose Naltrexone No text entered.
Placebo - Sugar Pill No text entered.
Total Total of all reporting groups

Baseline Measures
    Low Dose Naltrexone     Placebo - Sugar Pill     Total  
Number of Participants  
[units: participants]
  14     14     28  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     14     28  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  43.8  (13.4)     42.3  (13.0)     42.7  (12.9)  
Gender  
[units: participants]
     
Female     14     14     28  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     14     14     28  



  Outcome Measures
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1.  Primary:   Percent Change in Pain Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.   [ Time Frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) ]

2.  Secondary:   Percent Change in Sleep Quality Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.   [ Time Frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) ]

3.  Secondary:   Percent Change in Fatigue Scores Between Baseline to End of Placebo Treatment and Between Baseline to End of LDN Treatment.   [ Time Frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) ]

4.  Secondary:   Percent Change in Pressure Pain Threshold Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.   [ Time Frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) ]

5.  Secondary:   Percent Change in Heat Pain Sensitivity Between Baseline and End of Placebo Treatment and Between Baseline to End of LDN Treatment.   [ Time Frame: Baseline to end of placebo (2 weeks + 4 weeks) and baseline to end of LDN (2 weeks + 12 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jarred Younger, PhD
Organization: Stanford University School of Medicine
phone: 650-724-2795
e-mail: jyounger@stanford.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sean Mackey, Stanford University
ClinicalTrials.gov Identifier: NCT00568555     History of Changes
Other Study ID Numbers: SU-10232007-756
8948
Study First Received: December 4, 2007
Results First Received: April 10, 2013
Last Updated: September 21, 2015
Health Authority: United States: Institutional Review Board