A Phase 1 interventional study of Ibudilast 20mg and Ibudilast 50mg in Methamphetamine-dependence and Substance Abuse, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by University of California, Los Angeles · Phase 1, Interventional, and Other
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:
Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not looking for treatment will complete this study.
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.
The study will be conducted at the Harbor-UCLA hospital to ensure the medical safety of participants, especially if there are unexpected interactions between ibudilast and methamphetamine on cardiovascular function. Methamphetamine can cause substantial increases in heart rate and blood pressure that last for about 3 hours. This study will measure whether people who are meth-dependent (and not looking for treatment) show increases in their heart rate and blood pressures when given methamphetamine above what is expected by methamphetamine alone and when at the recommended doses of ibudilast.
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:
Over an enrollment period of 24 months, 12 methamphetamine-dependent participants who are not looking for treatment will complete this study. Each participant will complete assessments of safety/tolerability, perceived effects of methamphetamine, and an assessment where subjects make choices between different amounts of money and methamphetamine. Each patient will stay in the hospital for a total of 27 nights. The first two days consist of safety infusions to make sure methamphetamine is tolerable. Then, each subject will start study medication and take a 7-day course of three conditions: placebo, ibudilast 20mg BID, and ibudilast 50mg ibudilast. Low dose ibudilast always precedes high dose ibudilast. The order of placebo being first or last is random.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 11 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sequence: (1) Placebo, (2) Ibudilast 20 mg BID, then (3) Ibudilast 50 mg BID
Drug: Ibudilast 20mg · Drug: Ibudilast 50mg · Drug: Placebo oral tablet
Sequence: (1) Ibudilast 20 mg BID, (2) Ibudilast 50 mg BID, then (3) Placebo
Drug: Ibudilast 20mg · Drug: Ibudilast 50mg · Drug: Placebo oral tablet
Ibudilast 20mg BID
Also known as: IBUD
Ibudilast 50mg BID
Also known as: IBUD
Also known as: Placebo
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Insomnia, Nicotine craving, Gastrointestinal upset, Headache, Musculoskeletal pain, Pain at IV site, Rash, Vivid dreams, Constipation, Dizziness, Dysuria, Ectopic heart beats, Fever/chills/hot flashes, Pruritis, Sore throat, Tinnitus, Backache, Chest congestion, Sedation, or other reported by patient or observed by clinician
Time frame: 35 days
Number of Participants with Clinically Significant Changes in Cardiovascular Parameters as a Measure of Safety and Tolerability
Systolic and diastolic blood pressure, heart rate, and an EKG "rhythm strip"
Time frame: 35 days
Number of participants with adverse outcomes on (1) VAS, drug-effect scale, subjective effects, etc., and (2) pharmacokinetics of methamphetamine as measures of efficacy
1. Barratt Impulsiveness Scale-11; The Wechsler Test of Adult Reading; Wender Utah Rating Scale; subjective intensity of 12 drug effects on VAS. 2. blood concentrations of methamphetamine and amphetamine 3. cytokine panel from plasma
Time frame: 35 days
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles