Phase I Safety Interaction Trial of Ibudilast With Methamphetamine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of Participants with Clinically Significant Changes in Cardiovascular Parameters as a Measure of Safety and Tolerability
研究概览
简要总结
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:
- blood pressure and heart rate responses to methamphetamine;
- the ratings of craving or other drug experiences from methamphetamine;
- the reward/reinforcing effects of methamphetamine; and
- 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.
详细描述
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:
- blood pressure and heart rate responses to methamphetamine;
- the ratings of craving or other drug experiences from methamphetamine;
- the reward/reinforcing effects of methamphetamine; and
- the metabolism of methamphetamine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NOT seeking treatment for methamphetamine problems;
- •English-speaking;
- •Meet SCID criteria for MA dependence;
- •Self-reported history of MA use via injection or smoking AND at least one MA positive urine drug screening during eligibility;
- •Resting heart rate 50-100BPM; Systolic BP 105-150 mm Hg; Diastolic BP 45-90 mm Hg stabilized within 2 days of admission;
- •Baseline EKG demonstrating normal sinus rhythm, normal conduction, no clinically significant arrhythmias;
- •Use of acceptable barrier method of birth control;
- •If female, not pregnant or lactating;
- •Have medical history and physical examination demonstrating no additional clinically significant contraindications for study participation, in judgment of investigators.
排除标准
- •Current dependence on cocaine, opioids, marijuana, or alcohol;
- •Liver function tests GE 3x upper limit of normal, or kidney function tests GE 2x the upper limit of normal;
- •Current or past history of seizure disorder;
- •History of head trauma;
研究组 & 干预措施
placebo, Ibudilast 20 mg, then Ibudilast 50mg
Sequence: (1) Placebo, (2) Ibudilast 20 mg BID, then (3) Ibudilast 50 mg BID
干预措施: Ibudilast 20mg (Drug)
placebo, Ibudilast 20 mg, then Ibudilast 50mg
Sequence: (1) Placebo, (2) Ibudilast 20 mg BID, then (3) Ibudilast 50 mg BID
干预措施: Ibudilast 50mg (Drug)
placebo, Ibudilast 20 mg, then Ibudilast 50mg
Sequence: (1) Placebo, (2) Ibudilast 20 mg BID, then (3) Ibudilast 50 mg BID
干预措施: Placebo oral tablet (Drug)
Ibudilast 20 mg, Ibudilast 50mg, then placebo
Sequence: (1) Ibudilast 20 mg BID, (2) Ibudilast 50 mg BID, then (3) Placebo
干预措施: Ibudilast 20mg (Drug)
Ibudilast 20 mg, Ibudilast 50mg, then placebo
Sequence: (1) Ibudilast 20 mg BID, (2) Ibudilast 50 mg BID, then (3) Placebo
干预措施: Ibudilast 50mg (Drug)
Ibudilast 20 mg, Ibudilast 50mg, then placebo
Sequence: (1) Ibudilast 20 mg BID, (2) Ibudilast 50 mg BID, then (3) Placebo
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Number of Participants with Clinically Significant Changes in Cardiovascular Parameters as a Measure of Safety and Tolerability
时间窗: 35 days
Systolic and diastolic blood pressure, heart rate, and an EKG "rhythm strip"
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 35 days
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
次要结局
- Number of participants with adverse outcomes on (1) VAS, drug-effect scale, subjective effects, etc., and (2) pharmacokinetics of methamphetamine as measures of efficacy(35 days)