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OpenTrials
Completed

NCT Number: NCT00980044

Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

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.

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Key information

Conditions

Substance Withdrawal Syndrome Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Kentucky

Lexington, Kentucky, 40502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Addicted to opioids

Exclusion criteria

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

Treatment and study plan

Tramadol

Drug

Oral Medication

Other names: Brand name example: Ultram

Placebo

Drug

Oral Medication

Other names: Placebo is like a sugar pill

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Michelle Lofwall

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 18, 2009
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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