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Prescription Opioid Effects in Abusers Versus Non-Abusers

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ClinicalTrials.gov Identifier: NCT00158184
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

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
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rx Opioid Abusers Rx Opioid Non-Abusers
Hide Arm/Group Description The Abuse potential 3 doses of oral oxycodone (0, 15, 30 mg) were tested among a group of recreational prescription opioid (Rx) users. 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.
Period Title: Overall Study
Started 16 11
Completed 10 9
Not Completed 6 2
Reason Not Completed
personal issues             3             1
failed for follow unit/study rules             2             0
Adverse Event             1             1
Arm/Group Title Rx Opioid Abusers Rx Opioid Medical Users Total
Hide Arm/Group Description Prescription Opioids users with abusive patterns of use. Prescription Opioids users without abusive patterns of use. Total of all reporting groups
Overall Number of Baseline Participants 16 11 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 11 participants 27 participants
32  (8) 28  (6) 30  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 11 participants 27 participants
Female
12
  75.0%
7
  63.6%
19
  70.4%
Male
4
  25.0%
4
  36.4%
8
  29.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 11 participants 27 participants
16 11 27
1.Primary Outcome
Title Breakpoint
Hide Description Maximum number of finger presses on a computer mouse completed. The "Breakpoint" is the amount of work (clicks on a mouse) participants were willing to do in order to received the dose of drug under investigation. This is a commonly used indicator of a drugs value and abuse liability.
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rx Opioid Abusers Rx Opioid Non-Abusers
Hide Arm/Group Description:
Recreational prescription opioid users.
Medical prescription opioid users.
Overall Number of Participants Analyzed 10 9
Mean (Standard Error)
Unit of Measure: Mouse Clicks
Placebo: 0 mg 25  (20) 400  (200)
Oxycodone: 15mg 1400  (400) 850  (100)
Oxycodone: 30mg 1100  (350) 900  (160)
2.Secondary Outcome
Title Drug Liking
Hide Description Subjective rating of drug "Liking" on a scale of 0 to 100. Greater numbers indicate greater subjective report of "Liking."
Time Frame Highest rating obtained following adminstration of each of the 3 test doses.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rx Opioid Abusers Rx Opioid Non-Abusers
Hide Arm/Group Description:
Recreation users
Medical users
Overall Number of Participants Analyzed 10 9
Mean (Standard Error)
Unit of Measure: units on a scale
Placebo: 0 mg 23  (5) 21  (7)
Oxycodone: 15 mg 60  (7) 53  (8)
Oxycodone: 30 mg 59  (8) 40  (9)
Time Frame Averse events were assessed daily from the date of admission until the date of discharge. Participants also returned for a 30-Day follow-up after being discharged, during which adverse events were assessed.
Adverse Event Reporting Description Adverse events are classified as serious or non-serious.
 
Arm/Group Title Rx Opioid Abusers Rx Opioid Non-Abusers
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Rx Opioid Abusers Rx Opioid Non-Abusers
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Rx Opioid Abusers Rx Opioid Non-Abusers
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rx Opioid Abusers Rx Opioid Non-Abusers
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      0/11 (0.00%)    
Gastrointestinal disorders     
Nausea  [1]  2/16 (12.50%)  2 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Occurred after admission but prior to oral oxycodone being given.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Sandra D. Comer
Organization: Substance Use Research Center
Phone: 212-543-5981
EMail: sdc10@columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00158184    
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