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Tramadol to Reduce Opioid Withdrawal Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00142896
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Study Description
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Brief Summary:
Individuals with opioid addiction often experience serious withdrawal symptoms that may make relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by chronic conditions such as cancer or joint pain, may also be effective at reducing opioid withdrawal symptoms. This study will evaluate the effectiveness of tramadol at reducing withdrawal symptoms in individuals addicted to opioid drugs.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Tramadol Drug: Naloxone Drug: Morphine Phase 2

Detailed Description:

Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs often fail. Individuals with severe opioid withdrawal symptoms may experience shaking, muscle and bone pain, nausea, depression, anxiety, and drug craving. Tramadol is a medication that is currently used to treat moderate to severe pain in individuals with cancer, joint pain, or pain resulting from surgery. Because of its pharmacological profile, tramadol may also be useful in treating opioid withdrawal. Further research is needed to confirm the benefits of tramadol for opioid addicts. The purpose of this study is to evaluate the effectiveness of tramadol at reducing opioid withdrawal symptoms in opioid-dependent individuals.

This 6-week inpatient study will enroll opioid-dependent individuals. Participants will be required to reside at the research clinic for the entire study. All participants will receive morphine maintenance treatment on a daily basis. Twice a week participants will take part in experimental challenge sessions in which they will be randomly assigned to receive varying doses of tramadol, naloxone, morphine, or placebo. These sessions will assess the ability of tramadol to suppress opioid withdrawal symptoms. Participants will complete performance tasks to measure psychomotor and cognitive functioning. Heart rate and blood pressure will be monitored throughout the experimental sessions. A specialized camera will also be used to assess pupillary response of the eyes. Questionnaires and self-reports will be completed to assess medication effects and withdrawal symptoms. Following the end of the study, all participants will be offered outpatient drug abuse treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Withdrawal Suppression Efficacy of Tramadol
Study Start Date : February 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Opioid withdrawal symptoms (measured by Visual Analog Scale during the experimental sessions)
  2. Opioid agonist effects (measured by Visual Analog Scale during the experimental sessions)
  3. Physiological effects (measured by pulse oximeter, blood pressure, heart rate, and pupillary camera during the experimental sessions)

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets DSM-IV diagnostic criteria for opioid dependence
  • Is in good physical health
  • Qualifies for treatment with opioid agonist therapy (e.g., methadone)
  • If female, must have a negative pregnancy test prior to study entry

Exclusion Criteria:

  • Evidence of significant medical illness (e.g., insulin dependent diabetes mellitus)
  • Evidence of significant psychiatric illness (e.g., schizophrenia)
  • Currently seeking treatment for substance abuse
  • Pregnant or breastfeeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142896


Locations
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United States, Maryland
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224-6823
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Eric C. Strain, MD Johns Hopkins University
More Information
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Responsible Party: Eric C. Strain/Principal Investigator, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00142896    
Other Study ID Numbers: NIDA-18125-1
R01-18125-1
DPMC
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2008
Keywords provided by National Institute on Drug Abuse (NIDA):
Opiate Addiction
Opiate Dependence
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Morphine
Tramadol
Naloxone
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists