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Trial record 94 of 663 for:    OXYCODONE

Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers

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ClinicalTrials.gov Identifier: NCT01740414
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
MediciNova
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Conditions Opioid Abuse
Opioid Dependence
Interventions Drug: MN-166 (50 mg) First
Drug: Placebo First
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MN-166 First Placebo First
Hide Arm/Group Description Patient began maintenance on active medication first (MN-166, formerly AV411) prior to maintenance on placebo.The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (MN-166, then Placebo). Patient began maintenance on placebo medication prior to switching to the active medication condition(MN-166). The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo then MN-166).
Period Title: Overall Study
Started 12 16
Completed [1] 3 8
Not Completed 9 8
[1]
This study employed a within-subjects design. Participants completed both MN-166 and Placebo phases.
Arm/Group Title MN-166 (Formerly AV411) Placebo Total
Hide Arm/Group Description Patient began maintenance on active medication first (MN-166, formerly AV411) prior to maintenance on placebo. The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (MN-166, then placebo). Data are only from participants who completed both phases of the study. Patient began maintenance on placebo medication prior to maintenance active medication (MN-166, formerly AV411). The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo, then MN-166). Data are only from participants who completed both phases of the study. Total of all reporting groups
Overall Number of Baseline Participants 3 8 11
Hide Baseline Analysis Population Description
This was a within-subjects design, however, these numbers denote participant who began with Active (MN-166) maintenance, and those who began under Placebo maintenance.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 8 participants 11 participants
41.3  (10.8) 49.5  (1.7) 42.2  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 8 participants 11 participants
Female
0
   0.0%
1
  12.5%
1
   9.1%
Male
3
 100.0%
7
  87.5%
10
  90.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 8 participants 11 participants
3 8 11
1.Primary Outcome
Title Drug Self-administration Breakpoint
Hide Description Participants are allowed to perform an operant task (click on a mouse) in order to receive a dose drug under investigation (oxycodone dose 0 mg, 15 mg, or 30 mg). The drug breakpoint is the maximum number of responses (mouse clicks) the participant was willing to make to receive the drug. Within the context of abuse liability studies, larger breakpoints represent greater abuse potential of a drug.
Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MN-166 + Oxy 0 mg MN-166 + Oxy 15 mg MN-166 + Oxy 30 mg Placebo + Oxy 0 mg Placebo + Oxy 15 mg Placebo + Oxy 30 mg
Hide Arm/Group Description:
The Effects of 0 mg of oxycodone while under MN-166 maintenance.
The Effects of 15 mg of oxycodone while under MN-166 maintenance.
The Effects of 30 mg of oxycodone while under MN-166 maintenance.
The Effects of 0 mg of oxycodone while under placebo maintenance.
The Effects of 15 mg of oxycodone while under placebo maintenance.
The Effects of 30 mg of oxycodone while under placebo maintenance.
Overall Number of Participants Analyzed 11 11 11 11 11 11
Mean (Standard Error)
Unit of Measure: Clicks on a computer mouse
347  (360) 363  (180) 1472  (763) 43  (25) 1650  (948) 2459  (1184)
2.Secondary Outcome
Title Positive Subjective Effects to Oxycodone
Hide Description Participants are shown a 100-mm line and asked to indicate on that line the extent to which they agree with the descriptor of the drug effect such as "Liking/Liked the Drug." On this visual analog scale participants were instructed that the Left/ 0 mm point on the line represents "not at all," while the right/100 mm point represents “Extremely.”
Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MN-166 + Oxy 0 mg MN-166 + Oxy 15 mg MN-166 + Oxy 30 mg Placebo + Oxy 0 mg Placebo + Oxy 15 mg Placebo + Oxy 30 mg
Hide Arm/Group Description:
The Effects of 0 mg of oxycodone while under MN-166 maintenance.
The Effects of 15 mg of oxycodone while under MN-166 maintenance.
The Effects of 30 mg of oxycodone while under MN-166 maintenance.
The Effects of 0 mg of oxycodone while under placebo maintenance.
The Effects of 15 mg of oxycodone while under placebo maintenance.
The Effects of 30 mg of oxycodone while under placebo maintenance.
Overall Number of Participants Analyzed 11 11 11 11 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
.8  (5.6) 10.9  (23.9) 24.2  (35.1) .9  (3.4) 15.5  (27.2) 22.7  (36.9)
3.Other Pre-specified Outcome
Title Pain Intensity
Hide Description 15-item shortened form of the McGill Pain Questionnaire (Melzack, 1987) that is used to assess the sensory and affective dimensions of the pain experienced Participants describe their experience of pain by choosing among a series of possible answers (None [score=1], Mild [score=2], Moderate [score=3], or Severe [score=4]). They were asked to describe the pain as “Throbbing,” “Shooting,” “Stabbing,” “Sharp,” “Cramping,” “Gnawing,” “Hot-Burning,” “Aching,” “Heavy,” “Tender,” “Splitting,” “Tired-Exhausting,” “Sickening,” “Fearful,” and “Punishing-Cruel.” Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60.
Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MN-166 + Oxy 0 mg MN-166 + Oxy 15 mg MN-166 + Oxy 30 mg Placebo Oxy 0 mg Placebo + Oxy 15 mg Placebo + Oxy 30 mg
Hide Arm/Group Description:
The Effects of 0 mg of oxycodone while under MN-166 maintenance.
The Effects of 15 mg of oxycodone while under MN-166 maintenance.
The Effects of 30 mg of oxycodone while under MN-166 maintenance.
The Effects of 0 mg of oxycodone while under placebo maintenance.
The Effects of 15 mg of oxycodone while under placebo maintenance.
The Effects of 30 mg of oxycodone while under placebo maintenance.
Overall Number of Participants Analyzed 11 11 11 11 11 11
Mean (Standard Error)
Unit of Measure: units on a scale
30  (3) 25  (1) 26  (2) 31  (2) 29  (2) 27  (2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MN-166 (Formerly AV411) Placebo
Hide Arm/Group Description

Patient is receiving study drug (MN-166) first

MN-166 (formerly AV411): in one study arm, 50mg MN-166 BID are administered daily for 20 days

Patient is receiving placebo first.

placebo: In the placebo arm, the patients receive placebo for 20 days

All-Cause Mortality
MN-166 (Formerly AV411) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
MN-166 (Formerly AV411) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MN-166 (Formerly AV411) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/12 (25.00%)      7/16 (43.75%)    
Gastrointestinal disorders     
GI Upset   2/12 (16.67%)  4 4/16 (25.00%)  9
Nervous system disorders     
Insomnia   3/12 (25.00%)  8 7/16 (43.75%)  8
Headache   0/12 (0.00%)  2/16 (12.50%)  3
Fatigue   0/12 (0.00%)  2/16 (12.50%)  5
Back Ache   0/12 (0.00%)  1/16 (6.25%)  6
Psychiatric disorders     
Depression   1/12 (8.33%)  3 0/16 (0.00%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Sandra Comer
Organization: New York State Psychiatric Institute
Phone: 646-774-6146
EMail: comersd@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01740414     History of Changes
Other Study ID Numbers: #6021
P50DA009236 ( U.S. NIH Grant/Contract )
First Submitted: November 26, 2012
First Posted: December 4, 2012
Results First Submitted: June 13, 2017
Results First Posted: August 17, 2017
Last Update Posted: August 17, 2017