Safety Interaction Trial Ibudilast and Methamphetamine
Condition: Methamphetamine-dependence; Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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:

        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. 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.
    

Intervention name(s): Ibudilast 20mg; Ibudilast 50mg; Placebo oral tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ibudilast 20mg BID; Ibudilast 50mg BID
Other intervention name(s): IBUD; IBUD; Placebo
Intervention MeSH terms: Ibudilast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: methamphetamine; dependence; stimulant; amphetamine; los angeles; meth; speed; crank; abuse