Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

March 7, 2017 updated by: Michelle Lofwall
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Addicted to opioids

Exclusion Criteria:

  • Any major medical or psychiatric disorder that would be contraindicated for participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tramadol 200 mg then placebo
Tramadol 200 mg daily for 1 week then placebo given for 1 week
Drug: Tramadol
Oral Medication
Other Names:
  • Brand name example: Ultram
Placebo Comparator: Placebo for two weeks
Medication
Drug: Placebo
Oral Medication
Other Names:
  • 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 Names:
  • Brand name example: Ultram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Opioid Withdrawal Total Adjective Score
Time Frame: Days 1-7
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T
Days 1-7
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1
Time Frame: Days 1-7
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.
Days 1-7
Subjective Opioid Withdrawal Adjective Total Score Week 2
Time Frame: days 8-13
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present
days 8-13
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2
Time Frame: Days 8-13 (all groups now on placebo)
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.
Days 8-13 (all groups now on placebo)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michelle Lofwall

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Michelle Lofwall, M.D., University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (Estimate)

September 18, 2009

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

March 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0489
  • R01DA027068 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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