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Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01210079
First Posted: September 28, 2010
Last Update Posted: April 6, 2012
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 (Responsible Party):
Peggy Compton, University of California, Los Angeles
Results First Submitted: December 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Opioid-Induced Hyperalgesia
Interventions: Drug: Gabapentin;
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gabapentin Gabapentin titrated to 2400 mg daily PO for 5 weeks
Placebo Matched placebo group underwent identical 'titration' as intervention group.

Participant Flow:   Overall Study
    Gabapentin   Placebo
STARTED   10   16 
COMPLETED   10   16 
NOT COMPLETED   0   0 



  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.
No text entered.

Reporting Groups
  Description
Gabapentin Gabapentin titrated to 2400 mg daily PO for 5 weeks
Placebo Matched placebo group underwent identical 'titration' as intervention group.
Total Total of all reporting groups

Baseline Measures
   Gabapentin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   16   26 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   16   26 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.5  (4.46)   49.5  (4.96)   47.9  (5.05) 
Gender 
[Units: Participants]
     
Female   5   7   12 
Male   5   9   14 
Region of Enrollment 
[Units: Participants]
     
United States   10   16   26 


  Outcome Measures

1.  Primary:   Change in Pain Threshold Time From Baseline to Week 5   [ Time Frame: baseline, 5 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
Baseline hyperalgesia not established. Duration of trial only 5 weeks. Findings can only be generalized to methadone-maintained patients who are able to abstain from illicit drug use over an extended period of time.


  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: Margaret (Peggy) Compton, RN PhD
Organization: School of Nursing, University of California, Los Angeles
phone: (310) 206-2825
e-mail: pcompton@sonnet.ucla.edu



Responsible Party: Peggy Compton, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01210079     History of Changes
Other Study ID Numbers: R01 DA 05463
First Submitted: September 27, 2010
First Posted: September 28, 2010
Results First Submitted: December 5, 2011
Results First Posted: April 6, 2012
Last Update Posted: April 6, 2012