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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peggy Compton, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01210079
First received: September 27, 2010
Last updated: March 11, 2012
Last verified: February 2012
Results First Received: December 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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


No publications provided


Responsible Party: Peggy Compton, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01210079     History of Changes
Other Study ID Numbers: R01 DA 05463
Study First Received: September 27, 2010
Results First Received: December 5, 2011
Last Updated: March 11, 2012
Health Authority: United States: Institutional Review Board