Role of BP1.3656 on Alcohol Responses
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking study medication (BP1.3656).
研究概览
简要总结
The current study will determine whether a novel pharmacotherapy, BP1. 3656, affects laboratory alcohol self-administration in participants with alcohol use disorder (AUD).
详细描述
The current study employs BP1.3656, a novel investigational compound with a track record for safety and tolerability in phase I clinical trials. When administered to mice, BP1.3656 was associated with increased metabolism of histamine and elevated brain dopamine and acetylcholine, suggestive of utility in psychiatric disorders including Alcohol Use Disorder (AUD).
This study is a Phase II laboratory-based trial of BP1 .3656 for AUD. 40 non-treatment seeking participants with AUD will be recruited. Participants will be randomly assigned to intervention with BP1 .3656 or placebo in a within-subject, crossover design. During each intervention period, outcome measures relating to alcohol motivation and self-administration will be assessed in the laboratory. It is hypothesized that relative to placebo, alcohol self-administration will be decreased by BP1 .3656.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AUD with endorsement of 4-8 symptoms
- •Average weekly consumption ≥ 14 standard drinks for women and ≥ 21 standard drinks for men over the past 3 months
- •Willingness to take study medication and participate in laboratory sessions requiring alcohol administration
- •Able to give written informed consent
- •Certified as healthy by a comprehensive clinical assessment. Alanine transaminase (ALT) and aspartate aminotransferase (AST) levels should not be more than 1.2 times normal
排除标准
- •Seeking treatment for alcohol use (or current efforts to cut down or seek treatment)
- •A Clinical Institute Withdrawal Assessment (CIWA) score of 8+ upon initial assessment
- •Current medical conditions or medications that contraindicate receiving the study drug (based on the study physician's assessment)
- •Meeting criteria for a current substance use disorder aside from alcohol or nicotine
- •Recent recreational drug use (assessed via urine toxicology screen)
- •History of gross psychiatric or neurological impairment (e.g., schizophrenia, bipolar disorder, neurological disorders)
- •Reported difficulty with intravenous procedures
- •Self-report of significant alcohol-induced flushing after 1-2 drinks (a proxy for aldehyde dehydrogenase deficiency)
- •Currently nursing or pregnant (females)
- •Serious unstable medical condition
- •Current use of medication that could increase the risk of BP1.3656B administration
- •Having any clinical condition, drug sensitivity, or prior therapy which, in the investigator's opinion, makes the participant unsuitable for the study
- •Any history of seizures
研究组 & 干预措施
Medication (BP1.3656)
Participants will receive BP1.3656 in tablet form once daily at a dose of 30 µg/day for the first 4 days, followed by 60 µg/day for the remaining 10 days. If the highest dose is not tolerated, it will be lowered to 30 µg.
干预措施: BP1.3656 (Drug)
Placebo pills
Participants will receive matching placebo pills for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking study medication (BP1.3656).
时间窗: Measured during one progressive-ratio self-administration session in the 2nd week of the 14-day medication phase
Measured by number of button presses/work sets
Peak breath alcohol concentration (mg%) during free-access alcohol self-administration while taking placebo.
时间窗: Measured during one self-administration session in the 2nd week of the 14-day placebo phase.
Breath alcohol concentration (BrAC) test reading will be assessed
Peak breath alcohol concentration (mg%) during free-access alcohol self-administration while taking study medication (BP1.3656).
时间窗: Measured during one self-administration session in the 2nd week of the 14-day study medication phase.
Breath alcohol concentration (BrAC) test reading will be assessed
Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking placebo.
时间窗: Measured during one progressive-ratio self-administration session in the 2nd week of the 14-day placebo-phase.
Measured by number of button presses/work sets
次要结局
- Self-reported craving after a priming dose of alcohol during free-access and progressive ratio self-administration sessions while taking BP1.3656, as measured by the Alcohol Urge Questionnaire (1-7 scoring)(Measured during each of 2 alcohol self-administration sessions (free-access, progressive ratio) completed in 2nd week of medication phase.)
- Weekly alcohol consumption during treatment with BP1 .3656(Measured during the 2nd week of the 14-day study medication phase)
- Subjective effects of alcohol during free-access and progressive ratio self-administration sessions while taking study medication (BP1.3656), as measured by the Biphasic Alcohol Effects Scale (0-10 scoring)(Measured during each of two alcohol self-administration sessions (free-access, progressive ratio) completed in the 2nd week of the 14-day medication phase.)
- Self-reported craving after a priming dose of alcohol during free-access and progressive ratio self-administration sessions while taking placebo, as measured by the Alcohol Urge Questionnaire (1-7 scoring)(Measured during each of 2 alcohol self-administration sessions (free-access, progressive ratio) completed in 2nd week of placebo phase.)
- Safety and tolerability of BP1.3656(During the free-access and progressive ratio sessions in the 2nd week of the 14-day study placebo phase)
- Subjective effects of alcohol (maximum reported stimulation and sedation from alcohol) during free-access and progressive ratio self-administration sessions while taking placebo, as measured by the Biphasic Alcohol Effects Scale (0-10 scoring)(Measured during each of two alcohol self-administration sessions (free-access, progressive ratio) completed in the 2nd week of the 14-day placebo phase.)
- Weekly alcohol consumption during treatment with placebo(Measured during the 2nd week of the 14-day placebo phase)