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Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal (AV411)

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ClinicalTrials.gov Identifier: NCT00723177
Recruitment Status : Completed
First Posted : July 28, 2008
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Opioid-Related Disorders
Interventions Drug: AV411
Drug: Placebo (PCB)
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Low-dose AV411 High-dose AV411
Hide Arm/Group Description

This group received placebo AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks

This group will receive a low dose of AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks

This group will receive a high dose of AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally twice a day for two consecutive weeks

Period Title: Overall Study
Started 15 14 15
Completed 10 10 10
Not Completed 5 4 5
Arm/Group Title Placebo Low-dose AV411 High-dose AV411 Total
Hide Arm/Group Description

This group will receive placebo AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

This group will receive a low dose of AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

This group will receive a high dose of AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

Total of all reporting groups
Overall Number of Baseline Participants 15 14 15 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 15 participants 44 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
14
 100.0%
15
 100.0%
44
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 15 participants 14 participants 15 participants 44 participants
39  (4.5) 38  (5.3) 38  (4.3) 38  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 14 participants 15 participants 44 participants
Female
1
   6.7%
2
  14.3%
1
   6.7%
4
   9.1%
Male
14
  93.3%
12
  85.7%
14
  93.3%
40
  90.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 14 participants 15 participants 44 participants
15 14 15 44
1.Primary Outcome
Title Subjective Opioid Withdrawal Scale Score (SOWS)
Hide Description Measures severity of opioid withdrawal in opioid dependent populations (0-64). Larger values indicate more severe withdrawal.
Time Frame Measured at the end of each two-week maintenance period (i.e., Placebo, Low AV411, High AV411).
Hide Outcome Measure Data
Hide Analysis Population Description
Only 30 of the total number of 44 enrolled completed the study .
Arm/Group Title Placebo Low-dose AV411 High-dose AV411
Hide Arm/Group Description:

This group will receive placebo AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

This group will receive a low dose of AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

This group will receive a high dose of AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

Overall Number of Participants Analyzed 10 10 10
Mean (Standard Error)
Unit of Measure: units on a scale
16  (4) 4  (2) 24  (10)
2.Secondary Outcome
Title The Effects of AV411 on the Analgesic Effects of Oxycodone.
Hide Description The McGill Pain Questionnaire (Melzack, 1987) was used to assess pain experience immediately following the immersion of the hand in 4 degree Celsius water. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60. Larger scores indicate greater pain levels.
Time Frame Measured at the end of each AV411 of the three two-week maintenance periods
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Low-dose AV411 High-dose AV411
Hide Arm/Group Description:

This group will receive placebo AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

This group will receive a low dose of AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

This group will receive a high dose of AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
40  (5) 42  (7) 38  (5)
Time Frame We assessed for adverse events daily throughout the study and at 1 and 3 month follow-up time points. If a serious adverse events was experienced, it would have been reported to the appropriate oversight authorities within 24-48 hours.
Adverse Event Reporting Description An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that is: Fatal, Life-threatening, Requires or prolongs inpatient stay, Results in persistent or significant disability or incapacity.
 
Arm/Group Title Placebo Low-dose AV411 High-dose AV411
Hide Arm/Group Description

This group will receive placebo AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

This group will receive a low dose of AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

This group will receive a high dose of AV411

AV411: Placebo, low, and high dose of AV411 will be administered orally BID for two consecutive weeks

All-Cause Mortality
Placebo Low-dose AV411 High-dose AV411
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Low-dose AV411 High-dose AV411
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/14 (0.00%)      0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Low-dose AV411 High-dose AV411
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/15 (33.33%)      2/14 (14.29%)      5/15 (33.33%)    
Gastrointestinal disorders       
GI upset and Constipation   3/15 (20.00%)  3 2/14 (14.29%)  4 2/15 (13.33%)  2
Social circumstances       
Insomnia   2/15 (13.33%)  3 2/14 (14.29%)  3 3/15 (20.00%)  5
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: Sandra Comer PhD
Organization: NYSPI/Columbia University
Phone: 646 774-6146
EMail: SDC10@columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00723177    
Other Study ID Numbers: #5725
P50DA009236 ( U.S. NIH Grant/Contract )
First Submitted: July 24, 2008
First Posted: July 28, 2008
Results First Submitted: March 23, 2015
Results First Posted: December 5, 2016
Last Update Posted: December 5, 2016