Tramadol to Reduce Opioid Withdrawal Symptoms

NCT00142896 | Completed Phase 2

• 3 other identifiers: NIDA-18125-1R01-18125-1DPMC
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-Related Disorders

Keywords

Opiate Addiction; Opiate Dependence

Outcome Measures

Primary Outcomes (3)

• 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)

Interventions

Tramadol DRUG

Naloxone DRUG

Morphine DRUG

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

Johns Hopkins University (BPRU) Bayview Campus

Baltimore, Maryland, 21224-6823, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Tramadol; Naloxone; Morphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives

Study Officials

• Eric C. Strain, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: February 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: January 12, 2017

Record last verified: 2008-08

Locations

US (1)