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=5 Participants	42.8 years STANDARD_DEVIATION 10.5 • n=7 Participants	41.9 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	43 Participants n=7 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Baseline methamphetamine use on 26 or more days per month	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

End 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

Keith Heinzerling MD

UCLA

Phone: 310-319-4700

Email: kheinzerling@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60