A Pilot Placebo-controlled Human Laboratory Feasibility Study of Lacosamide Effects in Alcohol Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events)
研究概览
简要总结
The overall goal of the proposed project is to improve the treatment of individuals with AUD. The investigators will conduct the first pilot human laboratory study to assess the effects of two doses of lacosamide on alcohol drinking and craving. The investigators will assess its effects on reducing alcohol intake using a human laboratory method, the Yale Alcohol Drinking Paradigm (ADP). The investigators will also assess the feasibility of the Alcohol Drinking Paradigm (ADP) in order to position our research team to have the capacity to conduct future, larger, hypothesis-testing human laboratory-based experiments designed to test the efficacy of potential alcohol treatments.
详细描述
Four heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will undergo 3 ADP sessions. In each of the 3 ADP sessions, they will receive one of the following 3 different interventions: either 100 mg of lacosamide, 200 mg of lacosamide or placebo.
The ADP session is a one day human laboratory session at the SFVA Medical Center. This human laboratory session involves the self-administration of alcoholic beverages by research participants under highly structured, observed conditions in order to evaluate the effects of the study drug interventions (either 100 mg lacosamide, 200 mg lacosamide, or placebo) on alcohol craving and alcohol consumption. The study follows a double-blind placebo-controlled crossover design in which each participant receives each of the 3 drug interventions in a randomly assigned sequence. There were 4 possible sequences representing the 4 arms of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind, placebo-controlled
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men, ages 21-50;
- •Able to read English and to complete study evaluations;
- •Meet DSM-V criteria for current alcohol use disorder (AUD);
- •Average weekly alcohol use of 25-70 standard drinks for men over the past 30 days;
- •No more than 3 days/week of alcohol abstinence in the past 30 days, to maximize likelihood that participants will choose to drink during the laboratory sessions.
排除标准
- •Individuals who are seeking AUD treatment or have been in treatment within the past 6 months;
- •Current DSM-V non-alcohol use disorder other than tobacco or cannabis;
- •Positive urine drug test results at more than one baseline appointment for opioids, cocaine, benzodiazepines or barbiturates;
- •Regular use of psychoactive drugs including antipsychotics, anxiolytics and antidepressants during the 30 days prior to entry, as well as anticonvulsants, beta blockers, central nervous system stimulants or depressants, or other drugs that cause excessive sedation;
- •Taking medications that may interact with lacosamide, e.g. medications that prolong the ECG PR interval, or medications with strong CYP3A4 and CYP2C9;
- •Psychosis or any other serious mental illness as judged by SCID and study physician assessment;
- •Medical conditions that in the judgment of the study physician contraindicate the consumption of alcohol;
- •Medical conditions that in the judgment of the study physician contraindicate LAC (non contraindications listed in the FDA-approved Prescribing Information for LAC);
- •Any other medical conditions that in the opinion of the study physician would make study participation hazardous;
- •History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a Clinical Institute Withdrawal Assessment Scale (CIWA-AD) score greater than or equal to 8;
- •Participants who report disliking spirits will be excluded because 80 proof liquor will be provided during the alcohol self-administration periods;
- •Participants who have taken any investigational drug within 4 weeks preceding study entry;
- •Participants with first-degree atrioventricular block (AV block), PR interval lengthened beyond 0.20 seconds or greater.
研究组 & 干预措施
Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg
Participants receive a single dose of Placebo in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg.
干预措施: Placebo (Drug)
Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg
Participants receive a single dose of Placebo in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg.
干预措施: Lacosamide 100 mg (Drug)
Crossover Sequence A: Placebo, then Lacosamide 200 mg, then Lacosamide 100 mg
Participants receive a single dose of Placebo in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg.
干预措施: Lacosamide 200 mg (Drug)
Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo
Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 100 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
干预措施: Placebo (Drug)
Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo
Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 100 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
干预措施: Lacosamide 100 mg (Drug)
Crossover Sequence B: Lacosamide 200 mg, then Lacosamide 100 mg, then Placebo
Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 100 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
干预措施: Lacosamide 200 mg (Drug)
Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg
Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Placebo. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg.
干预措施: Placebo (Drug)
Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg
Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Placebo. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg.
干预措施: Lacosamide 100 mg (Drug)
Crossover Sequence C: Lacosamide 200 mg, then Placebo, then Lacosamide 100 mg
Participants receive a single dose of Lacosamide 200 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Placebo. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Lacosamide 100 mg.
干预措施: Lacosamide 200 mg (Drug)
Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo
Participants receives a single dose of Lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
干预措施: Placebo (Drug)
Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo
Participants receives a single dose of Lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
干预措施: Lacosamide 100 mg (Drug)
Crossover Sequence D: Lacosamide 100 mg, then Lacosamide 200 mg, then Placebo
Participants receives a single dose of Lacosamide 100 mg in ADP Session 1. After a 1 week washout period, they undergo ADP Session 2 in which they receive a single dose of Lacosamide 200 mg. After another 1 week washout period, they undergo ADP Session 3 in which they receive a single dose of Placebo.
干预措施: Lacosamide 200 mg (Drug)
结局指标
主要结局
Tolerability (Number of Participants With Mild, Moderate, or Severe Adverse Events)
时间窗: 3 days (1 day each for ADP Session 1, 2, and 3)
Tolerability will be measured by the number of participants with mild, moderate, and severe adverse events for each of the 3 drug interventions (100 mg lacosamide, 200 mg lacosamide and placebo).
Recruitment Feasibility (Time, in Months,) Required to Recruit, Screen and Conduct the Study Procedures
时间窗: 7 months
Recruitment feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 4 participants.
Retention Feasibility (Proportion of Participants Completing the Alcohol Drinking Paradigm (ADP) Sessions)
时间窗: 6.5 weeks
Retention feasibility will be measured by the proportion of participants completing the Alcohol Drinking Paradigm (ADP) Sessions 1, 2 and 3.
次要结局
- Alcohol Consumption (Number of Standard Drinks Consumed)(3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).)
- Alcohol Craving(3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).)
- Subjective Effects of Alcohol Consumption(3 days (1 day each for ADP Session 1, 2, and 3. Each ADP Session included 1 dose of the drug intervention, either Placebo, Lacosamide 100 mg, or Lacosamide 200 mg).)