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Related Studies
Tramadol to Reduce Opioid Withdrawal Symptoms
This study has been completed.
First Received: September 1, 2005   Last Updated: August 14, 2008   History of Changes
Sponsor: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00142896
  Purpose

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 Intervention Phase
Opioid-Related Disorders
 Drug: Tramadol
Drug: Naloxone
Drug: Morphine
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacodynamics Study
Official Title: Withdrawal Suppression Efficacy of Tramadol

Resource links provided by NLM:

Drug Information available for: Tramadol Naloxone
U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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)

Enrollment: 16
Study Start Date: February 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142896

Locations
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
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Johns Hopkins University School of Medicine ( Eric C. Strain/Principal Investigator )
Study ID Numbers: NIDA-18125-1, R01-18125-1, DPMC
Study First Received: September 1, 2005
Last Updated: August 14, 2008
ClinicalTrials.gov Identifier: NCT00142896     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
Opiate Addiction
Opiate Dependence

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

ClinicalTrials.gov processed this record on February 08, 2010



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