Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Information source: University of Kentucky
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Substance Withdrawal Syndrome
Intervention: Tramadol (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: University of Kentucky Official(s) and/or principal investigator(s):
Michelle Lofwall, M.D., Principal Investigator, Affiliation: University of Kentucky
Summary
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.
Clinical Details
Official title: Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Opioid Withdrawal
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Addicted to opioids
Exclusion Criteria:
- Any major medical or psychiatric disorder that would be contraindicated for
participation
Locations and Contacts
University of Kentucky, Lexington, Kentucky 40502, United States; Recruiting
Lofwall, Phone: 866-933-4859
Phone: 859-257-4581
Michelle Lofwall, M.D., Principal Investigator
Additional Information
Starting date: October 2009
Last updated: November 4, 2009
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