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The Discriminative Effects of Tramadol in Humans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00499746
First Posted: July 11, 2007
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eric Strain, MD, Johns Hopkins University
Results First Submitted: August 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Opioid Abuse
Opioid Addiction
Stimulant Abuse
Stimulant Addiction
Interventions: Drug: tramadol
Drug: placebo
Drug: Hydromorphone
Drug: Methylphenidate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Participants Participant flow is reported in single group due to the number of randomized sequences. In Phase 1 and Phase 2, each participant received two exposures of each training drug in randomize order (placebo, Hydromorphone 8 mg, Methylphenidate 60 mg). In Phase 3, each participant received randomized exposure to placebo, Hydromorphone (4 and 8 mg), Methylphenidate (30 and 60 mg), tramadol (50, 100, 200, and 400 mg).

Participant Flow for 3 periods

Period 1:   Phase 1(6-9 One Day Sessions)
    All Participants
STARTED   20 
COMPLETED   8 
NOT COMPLETED   12 
Failed to perform study task                7 
Withdrawal by Subject                3 
Investigator decision                1 
Unable to determine                1 

Period 2:   Phase 2 (6-9 One Day Sessions)
    All Participants
STARTED   8 
COMPLETED   8 
NOT COMPLETED   0 

Period 3:   Phase 3 (9-14 One Day Sessions)
    All Participants
STARTED   8 
COMPLETED   8 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 1 No text entered.

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.3  (2.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      8 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Acquisition of Discrimination Assessed by Accuracy of the Discrimination Test   [ Time Frame: 1 day ]

2.  Primary:   Discrimination Effects Assessed by Operant Responses   [ Time Frame: 1 day ]

3.  Primary:   Discrimination Effects Assessed by Point Distribution   [ Time Frame: 1day ]

4.  Primary:   Discrimination Effects Assessed by Discrete Choice   [ Time Frame: 1 day ]

5.  Secondary:   Physiologic Effects Assessed by the Pharmacological Class Questionnaire   [ Time Frame: Measure at 120 min after drug administration ]

6.  Secondary:   Physiological Effects Assessed by Peak Change From Baseline Pupil Diameter   [ Time Frame: Measure at 120 min after drug administration ]

7.  Secondary:   Peak Change From Baseline Opioid Agonist Effects Assessed by the Visual Analog Scale (VAS)   [ Time Frame: Measure at 120 min after drug administration ]

8.  Secondary:   Peak Change From Baseline Stimulant Effects Assessed by the Visual Analog Scale (VAS)   [ Time Frame: Measure at 120 min after drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eric C. Strain, M.D.
Organization: Johns Hopkins University School of Medicine
phone: 410-550-1191
e-mail: ecsgss@aol.com


Publications of Results:

Responsible Party: Eric Strain, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00499746     History of Changes
Other Study ID Numbers: NIDA-18125-3
R01DA018125 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
First Submitted: July 9, 2007
First Posted: July 11, 2007
Results First Submitted: August 18, 2012
Results First Posted: October 17, 2017
Last Update Posted: October 17, 2017