Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

This study is currently recruiting participants.

Verified November 2009 by University of Kentucky

First Received on September 17, 2009. Last Updated on November 4, 2009 History of Changes

Sponsor:	University of Kentucky
Information provided by:	University of Kentucky
ClinicalTrials.gov Identifier:	NCT00980044

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 II Phase III

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
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 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	Recruiting
Lexington, Kentucky, United States, 40502
Contact: Lofwall 866-933-4859
Contact 859-257-4581
Principal Investigator: Michelle Lofwall, M.D.

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 M.D., University of Kentucky College of Medicine
ClinicalTrials.gov Identifier:	NCT00980044 History of Changes
Other Study ID Numbers:	09-0489, R01DA027068
Study First Received:	September 17, 2009
Last Updated:	November 4, 2009
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 February 09, 2012