The Potential Therapeutic Effects of add-on Low Dose Dextromethorphan and Memantine in Patients With Amphetamine-type Stimulants Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Side effects checklists
研究概览
简要总结
The current study will investigate whether add-on dextromethorphan (DM) and memantine (MM) is able to improve the treatment outcomes for ATSUD, and be associated with improvement in inflammatory markers, neurotrophic factors and neuropsychological tests.
详细描述
In current study, we will conduct a randomized double-blind placebo-controlled study. We will recruit 100-120 patients with ATSUD in three years and allocate them to add-on low dose dextromethorphan and memantine (DM 30mg/day+MM 5mg/day) or placebo group in a 1: 1 ratio (patients will also undergo usual psychosocial interventions). We will follow up the participants for 12 weeks and measure the treatment responses, urine drug tests, craving scales and side effects to evaluate the therapeutic effects of add-on DM+MM. Neuropsychological assessments and tests for inflammatory parameters and neurotrophic factors will also be measured during 12-weeks follow up. The study results will show that whether add-on DM+MM is able to improve the treatment outcomes for ATSUD, and be associated with improvement in inflammatory markers, neurotrophic factors and neuropsychological tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of these inclusion criteria to be eligible for enrollment into the study:
- •Signed informed consent by patient or legal representative.
- •Male or female patient aged ≧20 and ≦65 years.
- •A diagnosis of ATSUD according to DSM criteria made by a specialist in psychiatry.
- •Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.
排除标准
- •The presence of any of the following will exclude a patient from study enrollment:
- •Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study.
- •Females who are pregnant or lactation.
- •Other major Axis-I DSM-IV diagnosis other than ATSUD, except for tobacco use disorder, ATS induced mood or psychotic disorders.
- •Current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation.
- •History of allergy or intolerable side effects of DM or MM.
- •Suicidal attempts or risks during screen or study period.
- •Presence of active infectious or autoimmune disease.
研究组 & 干预措施
dextromethorphan and memantine (DM+MM)
The patients with Amphetamine-type stimulants use disorder will be recruited and received treatment of add-on dextromethorphan 30mg/day and memantine 5mg/day combination (DM+MM) for 12 weeks.
干预措施: dextromethorphan and memantine (DM+MM) (Drug)
Placebos
The patients with Amphetamine-type stimulants use disorder will be recruited and received treatment of add-on placebos for 12 weeks.
干预措施: Placebos (Drug)
结局指标
主要结局
Side effects checklists
时间窗: 12 weeks
The investigators will use the self-reported questionnaire, side effects checklists, to evaluate the side effects during the 12 weeks of treatment period in patients with ATSUD. The side effects assessment includes, A) Mental Status/6-item, B) Genito-Urinary/4-item, C) Cardiovascular/4-item, D) Head-Neck/10-item, E) Extremities/9-item, F) Skin/4-item, and G) Gastrointestinal Tract/2-item. The severity of side effects were divided into 4 degrees as follows: 0 = Not present; 1 = Mild or occasional; 2 = Moderate or occurs several times a day; and 3 = Severe or persistent. Scores in each subscale will be summated to get the final total scores. Higher scores indicate more severe side effects. The results of side effects checklists will be compared between the experimental and placebo group.
Urinary amphetamine tests
时间窗: 12 weeks
The urinary amphetamine tests will be examined during the 12 weeks of treatment period in patients with ATSUD and the results will be compared between the experimental and placebo groups.
Craving severity
时间窗: 12 weeks
The Visual analog scale (VAS) will be measured during the 12 weeks of treatment period in patients with ATSUD. The results will be compared between the experimental and placebo groups. The level of conscious craving was rated from 0 (none) to 100 (very much). Higher scores indicate more severe craving.
次要结局
- C-reactive protein(12 weeks)
- Wisconsin Card Sorting Test (WCST)(12 weeks)
- Wechsler Memory Scale - third edition (WMS-III)(12 weeks)
- Cytokines and neurotrophic factors(12 weeks)
- Continuous performance tests (CPT)(12 weeks)
研究者
Tzu-Yun Wang
Principal Investigator
National Cheng-Kung University Hospital