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Trial of Ibudilast for Methamphetamine Dependence (IBUD ph II)

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ClinicalTrials.gov Identifier: NCT01860807
Recruitment Status : Completed
First Posted : May 23, 2013
Results First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Keith Heinzerling, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Methamphetamine Dependence
HIV Infection
Interventions Drug: Ibudilast
Drug: Placebo
Enrollment 125
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ibudilast Placebo
Hide Arm/Group Description

Ibudilast 50 mg twice daily

Ibudilast

matching placebo twice daily

Placebo

Period Title: Overall Study
Started 64 61
Completed 34 32
Not Completed 30 29
Arm/Group Title Ibudilast Placebo Total
Hide Arm/Group Description

Ibudilast 50 mg twice daily

Ibudilast

matching placebo twice daily

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 64 61 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 61 participants 125 participants
40.9  (9.0) 42.8  (10.5) 41.9  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 125 participants
Female
15
  23.4%
18
  29.5%
33
  26.4%
Male
49
  76.6%
43
  70.5%
92
  73.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 125 participants
Hispanic or Latino
30
  46.9%
30
  49.2%
60
  48.0%
Not Hispanic or Latino
34
  53.1%
31
  50.8%
65
  52.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 125 participants
American Indian or Alaska Native
2
   3.1%
2
   3.3%
4
   3.2%
Asian
4
   6.3%
2
   3.3%
6
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.6%
1
   0.8%
Black or African American
7
  10.9%
7
  11.5%
14
  11.2%
White
29
  45.3%
30
  49.2%
59
  47.2%
More than one race
1
   1.6%
0
   0.0%
1
   0.8%
Unknown or Not Reported
21
  32.8%
19
  31.1%
40
  32.0%
Baseline methamphetamine use on 26 or more days per month  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 61 participants 125 participants
33
  51.6%
33
  54.1%
66
  52.8%
1.Primary Outcome
Title Methamphetamine Use
Hide Description End of treatment methamphetamine abstinence
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ibudilast Placebo
Hide Arm/Group Description:

Ibudilast 50 mg twice daily

Ibudilast

matching placebo twice daily

Placebo

Overall Number of Participants Analyzed 64 61
Measure Type: Count of Participants
Unit of Measure: Participants
9
  14.1%
10
  16.4%
Time Frame 12 week medication treatment period and 4 week post-treatment follow-up period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibudilast Placebo
Hide Arm/Group Description

Ibudilast 50 mg twice daily

Ibudilast

matching placebo twice daily

Placebo

All-Cause Mortality
Ibudilast Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)      0/61 (0.00%)    
Hide Serious Adverse Events
Ibudilast Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/64 (3.13%)      1/61 (1.64%)    
Cardiac disorders     
Chest Pain   0/64 (0.00%)  0 1/61 (1.64%)  1
Nervous system disorders     
Convulsion   1/64 (1.56%)  1 0/61 (0.00%)  0
Psychiatric disorders     
Suicide Attempt   1/64 (1.56%)  1 0/61 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ibudilast Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   57/64 (89.06%)      32/61 (52.46%)    
Gastrointestinal disorders     
Nausea   11/64 (17.19%)  9/61 (14.75%) 
Diarrhea   8/64 (12.50%)  7/61 (11.48%) 
Nervous system disorders     
Headache   32/64 (50.00%)  11/61 (18.03%) 
Psychiatric disorders     
Insomnia   10/64 (15.63%)  5/61 (8.20%) 
Indicates events were collected by systematic assessment
Study did not determine if ibudilast may help patients who have stopped methamphetamine use prior to starting medication
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Keith Heinzerling MD
Organization: UCLA
Phone: 310-319-4700
EMail: kheinzerling@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Keith Heinzerling, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01860807    
Other Study ID Numbers: 1R01DA035054-01 ( U.S. NIH Grant/Contract )
R01DA035054 ( U.S. NIH Grant/Contract )
First Submitted: May 20, 2013
First Posted: May 23, 2013
Results First Submitted: January 6, 2019
Results First Posted: January 30, 2019
Last Update Posted: January 30, 2019