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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

Tracking Information
First Submitted Date  ICMJE March 9, 2006
First Posted Date  ICMJE March 10, 2006
Last Update Posted Date April 17, 2015
Study Start Date  ICMJE January 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2006)
  • Self-reported effects
  • physiologic measures
  • observer ratings of effects
  • cognitive/performance measures
Change History Complete list of historical versions of study NCT00301210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Tramadol as a Treatment for Opioid Addiction
Official Title  ICMJE Assessment of the Level of Physical Dependence and Blockade Efficacy Produced by Tramadol
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Opioid-Related Disorders
Intervention  ICMJE Drug: Tramadol
oral doses four times per day
Other Name: Ultram
Study Arms  ICMJE
  • Experimental: 1
    tramadol dose 1
    Intervention: Drug: Tramadol
  • Experimental: 2
    tramadol dose 2
    Intervention: Drug: Tramadol
Publications * Lanier RK, Lofwall MR, Mintzer MZ, Bigelow GE, Strain EC. Physical dependence potential of daily tramadol dosing in humans. Psychopharmacology (Berl). 2010 Sep;211(4):457-66. doi: 10.1007/s00213-010-1919-3. Epub 2010 Jun 30.

*   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
Actual Enrollment  ICMJE
 (submitted: July 14, 2008)
9
Original Enrollment  ICMJE
 (submitted: March 9, 2006)
20
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00301210
Other Study ID Numbers  ICMJE NIDA-18125-2
R01DA018125-02 ( U.S. NIH Grant/Contract )
DPMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric C. Strain, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP