Tramadol to Reduce Opioid Withdrawal Symptoms

This study has been completed.

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00142896

First received: September 1, 2005

Last updated: August 14, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

August 14, 2008

Start Date ^ICMJE

February 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Opioid withdrawal
Opioid agonist effects
Physiological effects

Change History

Complete list of historical versions of study NCT00142896 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Opioid-Related Disorders

Intervention ^ICMJE

Drug: Tramadol
Drug: Naloxone
Drug: Morphine

Study Arm (s)

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

Enrollment ^ICMJE

Completion Date

December 2005

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

Gender

Both

Ages

21 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00142896

Other Study ID Numbers ^ICMJE

NIDA-18125-1, R01-18125-1, DPMC

Has Data Monitoring Committee

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

Information Provided By

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

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