Trial Outcomes & Findings for Trial of Ibudilast for Methamphetamine Dependence (NCT NCT01860807)
NCT ID: NCT01860807
Last Updated: 2019-01-30
Results Overview
End of treatment methamphetamine abstinence
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
125 participants
Primary outcome timeframe
12 weeks
Results posted on
2019-01-30
Participant Flow
Participant milestones
| Measure |
Ibudilast
Ibudilast 50 mg twice daily
Ibudilast
|
Placebo
matching placebo twice daily
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
61
|
|
Overall Study
COMPLETED
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
30
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Ibudilast for Methamphetamine Dependence
Baseline characteristics by cohort
| Measure |
Ibudilast
n=64 Participants
Ibudilast 50 mg twice daily
Ibudilast
|
Placebo
n=61 Participants
matching placebo twice daily
Placebo
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 9.0 • n=99 Participants
|
42.8 years
STANDARD_DEVIATION 10.5 • n=107 Participants
|
41.9 years
STANDARD_DEVIATION 10.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Baseline methamphetamine use on 26 or more days per month
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksEnd of treatment methamphetamine abstinence
Outcome measures
| Measure |
Ibudilast
n=64 Participants
Ibudilast 50 mg twice daily
Ibudilast
|
Placebo
n=61 Participants
matching placebo twice daily
Placebo
|
|---|---|---|
|
Methamphetamine Use
|
9 Participants
|
10 Participants
|
Adverse Events
Ibudilast
Serious events: 2 serious events
Other events: 57 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibudilast
n=64 participants at risk
Ibudilast 50 mg twice daily
Ibudilast
|
Placebo
n=61 participants at risk
matching placebo twice daily
Placebo
|
|---|---|---|
|
Nervous system disorders
Convulsion
|
1.6%
1/64 • Number of events 1 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
0.00%
0/61 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/64 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
1.6%
1/61 • Number of events 1 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
|
Psychiatric disorders
Suicide Attempt
|
1.6%
1/64 • Number of events 1 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
0.00%
0/61 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
Other adverse events
| Measure |
Ibudilast
n=64 participants at risk
Ibudilast 50 mg twice daily
Ibudilast
|
Placebo
n=61 participants at risk
matching placebo twice daily
Placebo
|
|---|---|---|
|
Nervous system disorders
Headache
|
50.0%
32/64 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
18.0%
11/61 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
|
Gastrointestinal disorders
Nausea
|
17.2%
11/64 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
14.8%
9/61 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
|
Psychiatric disorders
Insomnia
|
15.6%
10/64 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
8.2%
5/61 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
8/64 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
11.5%
7/61 • 12 week medication treatment period and 4 week post-treatment follow-up period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60