Pilot Study: Use of a Mobile Health Sensor in an Open Label Trial of Lorcaserin for the Treatment of Cannabis Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Adherence to device
研究概览
简要总结
This is a 10 week, open-label, prospective study, involving 10 volunteer participants with cannabis use disorder to test the feasibility and safety of using lorcaserin in addition to the feasibility, likability, and utility of a mobile sensor device in cannabis users. The study will be entirely outpatient. Upon study entry, participants will begin clinic visits at the Substance Treatment and Research Service (STARS) clinic. All consented participants will receive a Fitbit Charge HR device in week 1 to wear for the entire study and receive lorcaserin beginning in week 2 for a total of 8 weeks (weeks 2-9). At the beginning of week 10 following discontinuation of lorcaserin, the participants will continue to wear the Fitbit Charge HR device for this final week following completion of the medication trial. All participants will visit the clinic twice weekly to provide urine toxicology on THC, report on adverse events, complete additional assessments (outlined below), and upload de-identified data from the Fitbit Charge HR device to the secure encrypted Fitabase database. Study assessments will be collected at baseline, throughout the study, and 1 week following medication discontinuation. All participants will also receive medical management, a medication adherence focused psychosocial intervention that facilitates compliance with study medication and other study procedures, including adherence to wearing the Fitbit Charge HR device, and promotes abstinence from cannabis and other substances. Progressive voucher incentives will be provided for compliance with visit attendance and study procedures.
详细描述
Design Overview: This is a 10 week, open-label, prospective study, involving 10 volunteer participants with cannabis use disorder to test the feasibility and safety of using lorcaserin in addition to the feasibility, likability, and utility of a mobile sensor device in cannabis users. The study will be entirely outpatient Upon study entry, participants will begin clinic visits at the Substance Treatment and Research Service (STARS) clinic. All consented participants will receive a Fitbit charge HR mobile device in week 1 to wear for the entire study and receive lorcaserin beginning in week 2 for a total of 8 weeks (weeks 2-9). At the beginning of week 10 following discontinuation of lorcaserin, the participants will continue to wear the device for this final week following completion of the medication trial. All participants will visit the clinic twice weekly to provide urine toxicology on THC, report on adverse events, complete additional assessments (outlined below), and upload de-identified data from the device to a secure encrypted database. Study assessments will be collected at baseline, throughout the study, and 1 week following medication discontinuation. All participants will also receive medical management, a medication adherence focused psychosocial intervention that facilitates compliance with study medication and other study procedures, including adherence to wearing the device, and promotes abstinence from cannabis and other substances. Progressive voucher incentives will be provided for compliance with visit attendance and study procedures.
The specific aims of the project are:
- To determine whether lorcaserin is associated with a reduction from baseline in cannabis use in individuals with cannabis use disorder seeking treatment.
- To determine the tolerability of lorcaserin in this population.
- To evaluate the feasibility and likability of incorporating a mobile health sensor device in a treatment study for cannabis use disorder.
The primary outcome measures are:
- Lorcaserin will significantly reduce cannabis use during the study period as measured by self-report (Timeline Followback) and creatinine-normalized quantitative THC urine levels.
- Lorcaserin will be well tolerated in participants with cannabis use disorder as measured by the proportion of participants completing the study, adherence to medication, and the proportion of participants experiencing adverse events.
- Participants will find it feasible and likeable to utilize the Fitbit Charge HRTM in the study as measured by selfreport assessment of liking and adherence to wearing the device
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals between the ages of 18-60
- •Meets DSM-V criteria for a current cannabis use disorder
- •Seeking treatment for cannabis use disorder
- •THC-positive urine drug screen
- •Capable of giving informed consent and complying with study procedures
- •Has access to a mobile device with IOS7 or Android 4.4.2 capabilities or more recent operating systems
- •Not underweight (Defined as BMI ≥18.5)
排除标准
- •Lifetime history of DSM-V diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
- •Current DSM-V criteria for any other psychiatric disorder supported by the MINI that in the investigator's judgment is unstable, would be disrupted by the study medication, or is likely to require new pharmacotherapy or psychotherapy during the study period. Individuals who are currently stable on a psychotropic medication for at least 3 months may be included if in the investigator's opinion the psychotropic medication the patient is taking is compatible with the study medication (lorcaserin).
- •Individuals who meet DSM-V criteria for any substance use disorder other an cannabis, caffeine or nicotine use disorders
- •Pregnancy, lactation, or failure to use adequate contraceptive method in female patients who are currently engaging in sexual activity with men
- •Unstable medical conditions, such as AIDS, cancer, uncontrolled hypertension (blood pressure > 140/90), uncontrolled diabetes, pulmonary hypertension or heart disease
- •Legally mandated to participate in a substance use disorder treatment program
- •Current or recent history of significant violent orsuicidal behavior, risk for suicide or homicide psychiatrist
- •Currently meets DSM-V diagnosis for an eating disorder or is underweight (defined as BMI <18.5)
- •Elevated liver function tests (AST and ALT > 3 times the upper limit of normal) or impaired renal function
- •Known history of allergy, intolerance, or hypersensitivity to lorcaserin
- •Concurrent use of migraine medications ergotamine (Cafergot, Ergomar) or dihydroergotamine (Migranal), 5HT2B receptor agonists like cabergoline, or medications metabolized by CYP2D6 (thioridazine, tamoxifen, metoprolol, aripiprazole, codeine, etc)
- •No access to mobile device with IOS7 or Android 4.4.2 capabilities or more recent operating systems
研究组 & 干预措施
All participants
All participants will receive open label lorcaserin
干预措施: lorcaserin (Drug)
All participants
All participants will receive open label lorcaserin
干预措施: Fitbit Charge HR (Other)
结局指标
主要结局
Adherence to device
时间窗: weeks 1-10
days device is worn
Feasibility of implementing mobile health device in treatment trial for CUD
时间窗: assessed once at 10weeks (end of study)
5 question self-report on likability of device; eg: Question 1: did you like wearing the mobile sensor device to track your progress during treatment? Yes or No; Question 2: Would you continue to wear the mobile sensor device to track your behaviors? Yes or No; etc
Cannabis use
时间窗: weeks 1-10
urine toxicology
Cannabis Use
时间窗: weeks 1-10
Timeline Followback
adherence to medication
时间窗: weeks 1- 8
number of pills taken
次要结局
未报告次要终点
研究者
Christina Ann Brezing
research psychiatrist
New York State Psychiatric Institute