Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM: a 6-month Randomized Controlled Trial With 3 Months of Follow-up
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of methamphetamine-positive urine tests
研究概览
简要总结
The investigators recently conducted a double-blind, randomized controlled trial (n=60) of limited duration (12 weeks), and found that compared with placebo, oral mirtazapine, an FDA-approved antidepressant, significantly reduced meth use in those receiving mirtazapine, as determined by reduction in meth-positive urines. Sexual risk behaviors also declined significantly in the mirtazapine arm compared to placebo. Mirtazapine decreased meth use despite low adherence: by medical event monitoring system (MEMS) caps, only 48.5% of daily doses were taken. All participants received weekly substance use counseling and monthly, brief clinician-delivered adherence counseling. The investigators propose expanding upon these results by lengthening the treatment period to 24 weeks, with adherence reminders added to the counseling, and determining if efficacy is sustained up to 12 weeks after drug discontinuation. The sample size for this 9-month study is 120.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •born male, or born female and does not identify as female;
- •reports anal sex with men in the prior three months while under the influence of meth;
- •diagnosed with meth dependence by SCID;
- •interested in stopping or reducing meth use;
- •at least one meth-positive urine during screening and run-in period;
- •no current acute illness requiring prolonged medical care;
- •no serious chronic illnesses that are likely to progress clinically during trial participation;
- •able and willing to provide informed consent and adhere to visit schedule;
- •age 18-69 years;
- •baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by clinician in conjunction with symptoms, physical exam, and medical history
- •current CD4 count ≥ 200 cells/mm3; or CD4 count of 100 - 199 cells/mm3 and HIV viral load < 200 copies/mL
- •text-capable cell phone or access to email
排除标准
- •Evidence of current major depression by SCID;
- •history of bipolar disorder or psychotic disorder, as determined by SCID;
- •known allergy or previous adverse reaction to mirtazapine;
- •taking an anti-depressant medication within the past 30 days, including mirtazapine or a monoamineoxidase inhibitor;
- •moderate or severe liver disease (AST, ALT, and total bilirubin >= 5 times upper limit of normal);
- •impaired renal function (estimated GFR <40 ml/min);
- •currently participating in another research study;
- •pending legal proceedings with high risk for incarceration during the time of planned study participation;
- •any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures.
研究组 & 干预措施
Mirtazapine
mirtazapine 30 mg orally per day
干预措施: Mirtazapine (Drug)
Placebo
placebo (30 mg) orally per day
干预措施: Placebo (Drug)
结局指标
主要结局
Number of methamphetamine-positive urine tests
时间窗: weekly for 9 months
To determine the efficacy of mirtazapine vs placebo at 12 weeks and 24 weeks of treatment plus counseling, and to determine whether efficacy is sustained for an additional 12 weeks after discontinuation of treatment and counseling (weeks 24 to 36).
次要结局
- Sexual risk (see description)(9 months)
研究者
Phillip Coffin, MD, MIA
Director, Substance Use Research Unit
San Francisco Department of Public Health