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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Substance Withdrawal Syndrome
 Drug: Tramadol
Drug: Placebo
 Phase 2
Phase 3

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
Official Title: Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Resource links provided by NLM:

Drug Information available for: Tramadol
U.S. FDA Resources

Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Opioid Withdrawal [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2009
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tramadol Dose 1
Medication
 Drug: Tramadol
Oral Medication
Placebo Comparator: Placebo
Medication
 Drug: Placebo
Oral Medication
Experimental: Tramadol Dose 2
Medication
 Drug: Tramadol
Oral Medication

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Addicted to opioids

Exclusion Criteria:

  • Any major medical or psychiatric disorder that would be contraindicated for participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980044

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40502
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Michelle Lofwall, M.D. University of Kentucky
  More Information

No publications provided

Responsible Party: Michelle Lofwall, Principal Investigatory, University of Kentucky
ClinicalTrials.gov Identifier: NCT00980044     History of Changes
Other Study ID Numbers: 09-0489, R01DA027068
Study First Received: September 17, 2009
Last Updated: March 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Substance-Related Disorders
Mental Disorders
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013