Assessment of Tramadol as a Treatment for Opioid Addiction
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-Related Disorders
Intervention: Tramadol (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Eric C. Strain, MD, Principal Investigator, Affiliation: Johns Hopkins University
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.
Clinical Details
Official title: Assessment of the Level of Physical Dependence and Blockade Efficacy Produced by Tramadol
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Self-reported effectsphysiologic measures observer ratings of effects cognitive/performance measures
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Behavioral Pharmacology Research Unit, Baltimore, Maryland 21224, United States
Additional Information
Starting date: January 2006
Last updated: April 16, 2015
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