A Double-Blind, Randomized, Controlled Trial of MAP4343 Treatment, a Ligand of the Neurospecific Microtubule Associated Protein-2, for Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Timeline Follow-Back (TLFB) Interview
研究概览
简要总结
This is a Phase 2, single-site, randomized, double-blind, placebo-controlled, proof-of-concept (POC) study involving 6 weeks of MAP4343 in conjunction with 6 weeks of manual-guided counseling, with 2 follow-up visits at 1 week and 1 month post-treatment.
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)
盲法说明
Quadruple
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female volunteers, 18-65 years of age
- •Meets Diagnostic and Statistical Manual (DSM)-5 criteria for current Alcohol Use Disorder (AUD) of moderate or greater severity, defined by DSM-5 as ≥ 4 symptoms
- •In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (males: ≥ 5 drinks, females: ≥ 4 drinks) per week
- •Seeking research-based outpatient treatment for AUD and willing to comply with the protocol, take daily oral medication for 6 weeks and complete 10 study visits
- •Abstinent a minimum of 3 days (but not more than 30 days) prior to randomization
- •Negative Blood Alcohol Concentration (BAC) and a Clinical Institute Withdrawal Assessment (CIWA) score of ≤ 9 at randomization
- •In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, electrocardiogram (ECG), urine test, and routine lab tests
- •Females with childbearing potential must have a negative pregnancy test on both the screening and randomization visits and agree to use non-hormonal effective birth control for the study duration and 1 month post treatment.
- •Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent
排除标准
- •Significant medical disorders or clinically significant findings on ECG, urine or blood tests that increase potential risk or interfere with study participation as determined by the Study Physician
- •Liver function tests more than 3 times the upper limit of normal
- •Meets DSM-5 criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders other than alcohol or nicotine use disorders or mild cannabis use disorder
- •Urine drug test positive at screening for abused drugs other than cannabis. Subjects using cannabis will be excluded if they meet criteria for cannabis use disorder ≥ moderate level of severity
- •Treatment within the month prior to screening with an investigational drug or vaccine, or drugs that may influence study outcomes, e.g., disulfiram, naltrexone, acamprosate
- •Chronic use or need for psychotropic drugs. Note: some drugs with psychotropic properties (e.g., anti-hypertensive drugs) or antidepressant medication taken at a stable dose for ≥ 3 months and no longer meeting criteria for depressive or anxiety disorders are allowed if their use is judged by both the investigator and study physician not to pose a safety risk or impact the results of the study
- •No fixed domicile and/or no availability by home or mobile telephone
- •Treatment mandated by a legal authority
- •Failure to comply with study procedures
- •Subjects who require medical detoxification (Note: Subjects may proceed with study evaluation after completion of detoxification)
研究组 & 干预措施
MAP4343
Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling
干预措施: MAP4343 (Drug)
MAP4343
Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling
干预措施: Standardized behavioral counseling (Behavioral)
Placebo
Subjects will receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling
干预措施: Placebo (Drug)
Placebo
Subjects will receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling
干预措施: Standardized behavioral counseling (Behavioral)
结局指标
主要结局
Timeline Follow-Back (TLFB) Interview
时间窗: 90-day period prior to and throughout the study
The Timeline Follow-Back Interview provides quantity and frequency estimates of alcohol consumption for the 90-day period prior to and throughout the study.
Visual Analogue Scale of Craving (VAS; adapted from ACQ)
时间窗: At subject's Week 2 human laboratory session
The Visual Analogue Scale of Craving has 4 questions to assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity with a 0-20 point visual analogue scale for each item, with 0 indicating no craving and 20 indicating severe craving.
次要结局
- State-Trait Anxiety Inventory (STAI)(Subjects will be followed for up to 10 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Subjects will be followed for up to 10 weeks)
- Alcohol Craving Questionnaire-Short Form (ACQ-SF)(Subjects will followed for up to 10 weeks)
- Beck Depression Inventory (BDI-II)(Subjects will be followed for up to 10 weeks)
研究者
Barbara J. Mason
Principal Investigator
The Scripps Research Institute