CLINICAL TRIALS PROFILE FOR IBUDILAST

Clinical Trials for Ibudilast

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00723177 ↗	Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	Repeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration. The present study is designed to evaluate the effectiveness of AV411 to alter opioid-induced withdrawal symptoms.
NCT00723177 ↗	Phase IIa Study of AV411, a Glial Activation Inhibitor, for Opioid Withdrawal	Completed	New York State Psychiatric Institute	Phase 2	Repeated use and/or abuse of opioid medications is generally associated with a characteristic withdrawal syndrome that develops after cessation of drug administration. The present study is designed to evaluate the effectiveness of AV411 to alter opioid-induced withdrawal symptoms.
NCT01217970 ↗	Safety Interaction Trial Ibudilast and Methamphetamine	Completed	MediciNova	Phase 1	This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in outpatient settings with people who have methamphetamine dependence. This would be the first study to collect this information. This study is important because individuals with methamphetamine dependence often relapse to meth use, even when in treatment; some number of individuals who participate in an outpatient study will relapse to methamphetamine while taking ibudilast. It is crucial to know whether there may be interactions between ibudilast and methamphetamine before planning an outpatient clinical trial.Ibudilast is an exciting medication candidate for treating methamphetamine dependence. When individuals become abstinent from methamphetamine during early recovery, the body starts an inflammatory process in neurons, especially glial cells. Glial cells are important in that they provide support to the nerve cells that are involved in thought, movement, and other human activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells during early abstinence, which in turn may help individuals feel better and think better during treatment. The study specific aims are to determine whether ibudilast alters: 1. blood pressure and heart rate responses to methamphetamine; 2. the ratings of craving or other drug experiences from methamphetamine; 3. the reward/reinforcing effects of methamphetamine; and 4. the metabolism of methamphetamine. Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not looking for treatment will complete this study.
NCT01217970 ↗	Safety Interaction Trial Ibudilast and Methamphetamine	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	This study is designed to collect data to determine whether a medication, ibudilast, is safe for use as a potential treatment for methamphetamine-dependent people. For 18 years in Japan and South Korea, ibudilast has been used safely in humans as a treatment for asthma, pulmonary, and cardiovascular disease. It is not known whether ibudilast is safe to use in outpatient settings with people who have methamphetamine dependence. This would be the first study to collect this information. This study is important because individuals with methamphetamine dependence often relapse to meth use, even when in treatment; some number of individuals who participate in an outpatient study will relapse to methamphetamine while taking ibudilast. It is crucial to know whether there may be interactions between ibudilast and methamphetamine before planning an outpatient clinical trial.Ibudilast is an exciting medication candidate for treating methamphetamine dependence. When individuals become abstinent from methamphetamine during early recovery, the body starts an inflammatory process in neurons, especially glial cells. Glial cells are important in that they provide support to the nerve cells that are involved in thought, movement, and other human activities. By dampening inflammation in glial cells, ibudilast may preserve glial and other nerve cells during early abstinence, which in turn may help individuals feel better and think better during treatment. The study specific aims are to determine whether ibudilast alters: 1. blood pressure and heart rate responses to methamphetamine; 2. the ratings of craving or other drug experiences from methamphetamine; 3. the reward/reinforcing effects of methamphetamine; and 4. the metabolism of methamphetamine. Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not looking for treatment will complete this study.

Clinical Trial Conditions for Ibudilast

Condition Name

Condition Name
Intervention	Trials
Alcohol Use Disorder	3
Amyotrophic Lateral Sclerosis	3
Healthy Volunteers	2
Methamphetamine-dependence	2

Condition MeSH

Condition MeSH
Intervention	Trials
Alcoholism	5
Alcohol Drinking	5
Sclerosis	4
Amyotrophic Lateral Sclerosis	3

Clinical Trial Locations for Ibudilast

Trials by Country

Trials by Country
Location	Trials
United States	48
Canada	3
Australia	2

Trials by US State

Trials by US State
Location	Trials
California	9
New York	5
Oregon	3
Massachusetts	3
Pennsylvania	3

Clinical Trial Progress for Ibudilast

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	1
Phase 2/Phase 3	2
Phase 2	10

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Completed	12
Recruiting	5
Not yet recruiting	4

Clinical Trial Sponsors for Ibudilast

Sponsor Name

Sponsor Name
Sponsor	Trials
MediciNova	11
University of California, Los Angeles	5
National Institute on Drug Abuse (NIDA)	4

Sponsor Type

Sponsor Type
Sponsor	Trials
Other	22
Industry	12
NIH	8