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Prescription Opioid Effects in Abusers Versus Non-Abusers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00158184
First Posted: September 12, 2005
Last Update Posted: July 7, 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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
Results First Submitted: April 10, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Interventions: Drug: oxycodone 15 mg
Drug: oxycodone 30 mg
Drug: Placebo 0 mg

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rx Opioid Abusers The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of recreational prescription opioid (Rx) users.
Rx Opioid Non-Abusers The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of participants with no history of opioid abuse.

Participant Flow:   Overall Study
    Rx Opioid Abusers   Rx Opioid Non-Abusers
STARTED   16   11 
COMPLETED   10   9 
NOT COMPLETED   6   2 
personal issues                3                1 
failed for follow unit/study rules                2                0 
Adverse Event                1                1 



  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.
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Reporting Groups
  Description
Rx Opioid Abusers Prescription Opioids users with abusive patterns of use.
Rx Opioid Medical Users Prescription Opioids users without abusive patterns of use.
Total Total of all reporting groups

Baseline Measures
   Rx Opioid Abusers   Rx Opioid Medical Users   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   11   27 
Age 
[Units: Years]
Mean (Standard Deviation)
 32  (8)   28  (6)   30  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  75.0%      7  63.6%      19  70.4% 
Male      4  25.0%      4  36.4%      8  29.6% 
Region of Enrollment 
[Units: Participants]
     
United States   16   11   27 


  Outcome Measures
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1.  Primary:   Breakpoint   [ Time Frame: Measured at 0, 60, 120, 180 and 240 minutes following administration of each oral oxycodone dose (0 , 15, 30 mg). Results presented as mean of the session ]

2.  Secondary:   Drug Liking   [ Time Frame: Highest rating obtained following adminstration of each of the 3 test doses. ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Sandra D. Comer
Organization: Substance Use Research Center
phone: 212-543-5981
e-mail: sdc10@columbia.edu


Publications of Results:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00158184     History of Changes
Other Study ID Numbers: #4691
R01DA016759-01 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: April 10, 2013
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017