A Novel Compound for Alcoholism Treatment: A Translational Strategy - Part II
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Alcohol Cue-elicited Craving Assessed in a "Bar-like" Laboratory
研究概览
简要总结
Background:
Hormones are naturally occurring chemicals in the body. Ghrelin is a hormone that stimulates appetite. It may also stimulate alcohol cravings and use. Researchers want to learn more about alcohol cravings and test if a drug that blocks ghrelin lowers alcohol cravings.
Objective:
To test if the drug PF-05190457 decreases alcohol craving.
Eligibility:
People ages 18-70 who have:
Alcohol use disorder
No other serious medical problems
Woman must be postmenopausal or have had surgery to prevent pregnancy.
Design:
Participants will stay on the inpatient unit here at the Clinical Center for two 2-week stages, which will be separated by at least 2 days. The inpatient phase include:
Taking the study drug or placebo by mouth twice daily
Blood tests
Tasting several sweet solutions
Physical exams
Exposure to alcohol, water, and food cues in a bar-like room. Participants answer questions on a computer.
Blood pressure and heart rate are monitored through an arm cuff and sensors on the chest.
MRIs: Participants lie on a table that slides in and out of the cylinder, and a coil is placed over the head.
They complete tasks on a computer screen while in the cylinder. This lasts up to 2 hours.
Wearing a virtual reality headset, walking around a virtual room, and selecting virtual food and drink.
Physical exams
详细描述
Objective:
Ghrelin is a 28-amino acid peptide that stimulates appetite and food intake. It is an endogenous ligand for the growth hormone secretagogue receptor (GHSR1a). Preclinical studies suggest that ghrelin modulates alcohol reward processing. Previous work from our research team, indicated that intravenous (IV) ghrelin administration, compared to placebo, results in an acute increase in alcohol craving during a cue-reactivity experiment in alcoholic individuals. Therefore, an oral bioavailable, ghrelin receptor antagonist that is able to pass through the blood brain barrier holds particular promise as a treatment for alcohol use disorder (AUD). This protocol is part of a grant project funded by National Center for Advancing Translational Sciences (NCATS) aimed to generate preliminary evidence in AUD on the safety and efficacy of a ghrelin receptor (GHSR1a) antagonist, PF-05190457, an existing molecule available under the NIH-Industry Pilot Program at NCATS. Completed preclinical and clinical (Protocol #14-AA-0042) work has demonstrated the safety of PF-05190457/alcohol interaction. The goal of this protocol is to conduct a proof-of-concept human laboratory study to assess an early-signal of efficacy of PF-05190457 in AUD.
Study population:
The study population will be AUD individuals (n = 55).
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo, then PF-05190457
Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days followed by a minimum of 2-day washout period then PF-05190457 100 mg twice a day for a maximum of 14 days.
干预措施: Placebo (Other)
Placebo, then PF-05190457
Participants with alcohol use disorder received placebo twice a day for a maximum of 14 days followed by a minimum of 2-day washout period then PF-05190457 100 mg twice a day for a maximum of 14 days.
干预措施: PF-05190457 (Drug)
PF-05190457, then placebo
Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days followed by a minimum of 2-day washout period, then placebo twice a day for a maximum of 14 days.
干预措施: PF-05190457 (Drug)
PF-05190457, then placebo
Participants with alcohol use disorder received PF-05190457 100 mg twice a day for a maximum of 14 days followed by a minimum of 2-day washout period, then placebo twice a day for a maximum of 14 days.
干预措施: Placebo (Other)
结局指标
主要结局
Alcohol Cue-elicited Craving Assessed in a "Bar-like" Laboratory
时间窗: 96 minutes
Alcohol cue elicited craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
次要结局
- Food Choices in a "Virtual Buffet" Conducted in a Virtual Reality Context.(40 minutes)