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Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Lofwall, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00980044
First received: September 17, 2009
Last updated: March 12, 2012
Last verified: March 2012

September 17, 2009
March 12, 2012
October 2009
February 2012   (final data collection date for primary outcome measure)
Opioid Withdrawal [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00980044 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. This study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Substance Withdrawal Syndrome
  • Drug: Tramadol
    Oral Medication
  • Drug: Placebo
    Oral Medication
  • Experimental: Tramadol Dose 1
    Medication
    Intervention: Drug: Tramadol
  • Placebo Comparator: Placebo
    Medication
    Intervention: Drug: Placebo
  • Experimental: Tramadol Dose 2
    Medication
    Intervention: Drug: Tramadol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
March 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Addicted to opioids

Exclusion Criteria:

  • Any major medical or psychiatric disorder that would be contraindicated for participation
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00980044
09-0489, R01DA027068
No
Michelle Lofwall, University of Kentucky
University of Kentucky
Not Provided
Principal Investigator: Michelle Lofwall, M.D. University of Kentucky
University of Kentucky
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP