Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michelle Lofwall, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00980044
First received: September 17, 2009
Last updated: December 10, 2014
Last verified: December 2014
Results First Received: June 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Substance Withdrawal Syndrome
Interventions: Drug: Tramadol
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
Outpatient screening. Recruitment by advertisement and word or mouth.

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

Persons screening who did not meet inclusion/ exclusion criteria were not enrolled.

Persons who did not complete the study were not included in analyses. The study was designed as an efficacy study that a priori stated it would enroll until 12 persons in each group completed the study and analyse only completers. No serious AEs in noncompleters.


Reporting Groups
  Description
Tramadol 200 mg Daily Medication: Extended release tramadol 200 mg daily given for 1 week then placebo given for 1 week
Placebo Placebo given for two weeks
Tramadol 600 mg Daily Medication: Extended release tramadol 600 mg daily given for 1 week followed by 1 week of placebo dosing.

Participant Flow:   Overall Study
    Tramadol 200 mg Daily     Placebo     Tramadol 600 mg Daily  
STARTED     17     19     17  
COMPLETED     12     12     12  
NOT COMPLETED     5     7     5  
Withdrawal by Subject                 5                 7                 3  
Protocol Violation                 0                 0                 2  



  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.
The study was a priori defined to evaluate only completers. There were 12 completers in each of the three study arms. We retained the description of the completers because it corresponds to the primary outcomes results that are reported (and this is what was proposed a priori and approved by NIDA review).

Reporting Groups
  Description
Tramadol 200 mg Medication: Extended release tramadol for 1 week and then placebo given for 1 week
Placebo Medication: Placebo given for two weeks
Tramadol 600 mg Medication: Extended release tramadol 600 mg given for 1 week and then placebo given for 1 week
Total Total of all reporting groups

Baseline Measures
    Tramadol 200 mg     Placebo     Tramadol 600 mg     Total  
Number of Participants  
[units: participants]
  12     12     12     36  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     12     12     12     36  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  26.8  (0.9)     32.2  (2.2)     31.6  (1.5)     30.1  (1.5)  
Gender  
[units: participants]
       
Female     5     4     5     14  
Male     7     8     7     22  
Region of Enrollment  
[units: participants]
       
United States     12     12     12     36  



  Outcome Measures
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1.  Primary:   Subjective Opioid Withdrawal Total Adjective Score   [ Time Frame: Days 1-7 ]

2.  Primary:   Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1   [ Time Frame: Days 1-7 ]

3.  Primary:   Subjective Opioid Withdrawal Adjective Total Score Week 2   [ Time Frame: days 8-13 ]

4.  Primary:   Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2   [ Time Frame: Days 8-13 (all groups now on placebo) ]


  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
The study was designed to analyze only completers (12 subjects per group so the description of study participant characteristics and outcomes are from these a prior defined n=36 (12 per group) completers.


  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: Michelle Lofwall, MD, Associate Professor
Organization: University of Kentucky College of Medicine
phone: 8593239321
e-mail: michelle.lofwall@uky.edu


Publications of Results:

Responsible Party: Michelle Lofwall, University of Kentucky
ClinicalTrials.gov Identifier: NCT00980044     History of Changes
Other Study ID Numbers: 09-0489
R01DA027068 ( US NIH Grant/Contract Award Number )
Study First Received: September 17, 2009
Results First Received: June 10, 2013
Last Updated: December 10, 2014
Health Authority: United States: Food and Drug Administration