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Clinical Trials/NCT00301210
NCT00301210
Completed
Phase 1

Assessment of the Level of Physical Dependence and Blockade Efficacy Produced by Tramadol

Johns Hopkins University1 site in 1 country9 target enrollmentJanuary 2006
InterventionsTramadol

Overview

Phase
Phase 1
Intervention
Tramadol
Conditions
Opioid-Related Disorders
Sponsor
Johns Hopkins University
Enrollment
9
Locations
1
Primary Endpoint
Self-reported effects
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Opioids are one of the most commonly abused drugs among individuals who seek treatment for drug abuse. Thus, it is necessary to develop new treatments for opioid addiction. The purpose of this trial is determine whether tramadol is effective in treating opioid dependent individuals.

Detailed Description

This human laboratory study will test the effects of tramadol as a step in its development as a new treatment for opioid dependence. Tramadol is a moderate mu agonist opioid that may produce low levels of opioid physical dependence. Tramadol's capacity for producing physical dependence has not been systematically studied in humans. It is important to quantify tramadol, as it provides a measure of its opioid agonist effects. This would also be informative in regards to the abuse liability of tramadol when used as an analgesic (as currently marketed), or when used in the treatment of opioid addiction (as proposed in this study). The purpose of this trial is to evaluate the level of physical dependence as well as blockade efficacy produced by chronic maintenance on oral tramadol in opioid dependent individuals. Participants will be randomly assigned to receive different doses of tramadol or placebo for up to six weeks. Experimental sessions will take place up to three times per week during the treatment period. During challenge sessions, participants will receive an injection; four different kinds of effects may occur in a session following this injection. First, no effect may occur (a placebo). Second, an opioid agonist effect may occur (opioid agonists include heroin, morphine, hydromorphone, tramadol, and methadone), which may cause the participant to feel "high." Third, an opioid antagonist effect may occur (e.g., naloxone, naltrexone), which may cause the participant to feel a sense of opioid withdrawal.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
November 2007
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric C. Strain

Professor

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

  • Currently opioid dependent

Exclusion Criteria

  • Significant medical illness (e.g., diabetes mellitus)
  • History of seizure
  • Current sedative or alcohol dependence
  • Pregnant or breastfeeding

Arms & Interventions

1

tramadol dose 1

Intervention: Tramadol

2

tramadol dose 2

Intervention: Tramadol

Outcomes

Primary Outcomes

Self-reported effects

Time Frame: up to 4 hours for acute effects

physiologic measures

Time Frame: up to 4 hours for acute effects

observer ratings of effects

Time Frame: up to 4 hours for acute effects

cognitive/performance measures

Time Frame: up to 4 hours for acute effects

Study Sites (1)

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