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Tramadol to Reduce Opioid Withdrawal Symptoms

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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)

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE February 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
  • Opioid withdrawal symptoms (measured by Visual Analog Scale during the experimental sessions)
  • Opioid agonist effects (measured by Visual Analog Scale during the experimental sessions)
  • Physiological effects (measured by pulse oximeter, blood pressure, heart rate, and pupillary camera during the experimental sessions)
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
  • Opioid withdrawal
  • Opioid agonist effects
  • Physiological effects
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tramadol to Reduce Opioid Withdrawal Symptoms
Official Title  ICMJE Withdrawal Suppression Efficacy of Tramadol
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Opioid-Related Disorders
Intervention  ICMJE
  • Drug: Tramadol
  • Drug: Naloxone
  • Drug: Morphine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2005)
16
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00142896
Other Study ID Numbers  ICMJE NIDA-18125-1
R01-18125-1
DPMC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric C. Strain/Principal Investigator, Johns Hopkins University School of Medicine
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP