Trial of Ibudilast for Methamphetamine Dependence (IBUD ph II)

• 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: University of California, Los Angeles
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Ibudilast	Placebo
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

Baseline Characteristics

Arm/Group Title		Ibudilast	Placebo	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Methamphetamine Use
Description	End of treatment methamphetamine abstinence
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ibudilast	Placebo
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%

Adverse Events

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
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%)
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
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

Limitations and Caveats

Study did not determine if ibudilast may help patients who have stopped methamphetamine use prior to starting medication

More Information

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

• Name/Title: Keith Heinzerling MD
• Organization: UCLA
• Phone: 310-319-4700
• EMail: kheinzerling@mednet.ucla.edu

• 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