Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

This study has been completed.
Sponsor:
Collaborator:
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
  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:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Subjective Opioid Withdrawal Total Adjective Score [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
    range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T

  • Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1 [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
    There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.

  • Subjective Opioid Withdrawal Adjective Total Score Week 2 [ Time Frame: days 8-13 ] [ Designated as safety issue: No ]
    range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present

  • Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2 [ Time Frame: Days 8-13 (all groups now on placebo) ] [ Designated as safety issue: No ]
    There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.


Enrollment: 53
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 200 mg then placebo
Tramadol 200 mg daily for 1 week then placebo given for 1 week
Drug: Tramadol
Oral Medication
Other Name: Brand name example: Ultram
Placebo Comparator: Placebo for two weeks
Medication
Drug: Placebo
Oral Medication
Other Name: Placebo is like a sugar pill
Experimental: Tramadol 600 mg then placebo
Tramadol 600 mg daily given for 1 week given then placebo given for 1 week
Drug: Tramadol
Oral Medication
Other Name: Brand name example: Ultram

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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
Results First Received: June 10, 2013
Last Updated: December 10, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2015