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Assessment of Tramadol as a Treatment for Opioid Addiction

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ClinicalTrials.gov Identifier: NCT00301210
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : April 17, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Eric C. Strain, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Tramadol Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Level of Physical Dependence and Blockade Efficacy Produced by Tramadol
Study Start Date : January 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1
tramadol dose 1
Drug: Tramadol
oral doses four times per day
Other Name: Ultram
Experimental: 2
tramadol dose 2
Drug: Tramadol
oral doses four times per day
Other Name: Ultram



Primary Outcome Measures :
  1. Self-reported effects [ Time Frame: up to 4 hours for acute effects ]
  2. physiologic measures [ Time Frame: up to 4 hours for acute effects ]
  3. observer ratings of effects [ Time Frame: up to 4 hours for acute effects ]
  4. cognitive/performance measures [ Time Frame: up to 4 hours for acute effects ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301210


Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Eric C. Strain, MD Johns Hopkins University

Publications of Results:
Responsible Party: Eric C. Strain, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00301210     History of Changes
Other Study ID Numbers: NIDA-18125-2
R01DA018125-02 ( U.S. NIH Grant/Contract )
DPMC
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents