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临床试验/NCT03137082
NCT03137082已完成1 期

Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)

Stony Brook University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年7月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
32
试验地点
1
主要终点
Percentage of Days Abstinent

研究概览

简要总结

Guanfacine may preferentially reduce craving and improve cognitive control in women with Alcohol Use Disorder (AUD), compared to men. As these behaviors are related to relapse, the objectives of this study are to conduct a 10-week out-patient clinical trial to examine the effects of Guanfacine Extended Release (XR; 3mgs) versus placebo on drinking measures in women with AUD.

详细描述

Gender-specific variation in sympathetic sensitivity (Fox et al., 2014; Fox and Sinha, 2009; Cahill, 2003; Heinsbroek et al., 1991) may mean that guanfacine is particularly efficacious in attenuating drinking in women, rather than men with Alcohol Use Disorder (AUD). Thus, the investigators propose a double blind, placebo-controlled, 10-week randomized clinical trial to examine the effects of Guanfacine XR (3mgs/daily) versus placebo in 60 women with AUD. This will include twice weekly appointments comprising medical management and contingency management protocols, collection of urine, breathalyzer screens, and vitals. Measures of craving and mood will also be assessed. Parallel laboratory challenge studies will also be conducted both on admission to out-patient treatment and again following 4 weeks of treatment, in order to better elucidate the potentially therapeutic mechanisms of guanfacine. Participants will be exposed to a personal stress versus relaxing imagery condition, 1 condition per day, in a randomized order. Craving, anxiety, mood, cognitive control, heart rate and blood pressure (HRBP), and biological stress system markers will be assessed at baseline, following imagery and at various recovery timepoints.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Must meet Diagnostic and Statistical Manual of Mental Disorders-V (DSM- V) criteria for moderate to severe Alcohol Use Disorder (AUD),
  • Must produce positive urine toxicology screens on admission to study
  • Must demonstrate good health as verified by screening examination
  • Must be able to read English and complete study evaluations
  • Must be able to provide informed written and verbal consent

排除标准

  • Meeting current use disorder for any other psychoactive substance, excluding nicotine.
  • Having any other current Axis I psychiatric disorders or medical conditions requiring treatment or medication
  • EKG evidence at baseline screening of any clinically significant conduction abnormalities including a Bazlett's QTc (corrected QT interval) of >470 msec.
  • Must not be on monophasic contraceptives, nursing or pregnant.

研究组 & 干预措施

Guanfacine XR 3mgs/daily

Experimental
  • Guanfacine XR tablet by mouth every 24 hours for 12 weeks
  • 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
  • Full dose: 3mgs/d (day 21- day 70)
  • 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)

干预措施: Guanfacine XR 3mgs/daily (Drug)

Placebo (for guanfacine)

Placebo Comparator
  • Guanfacine XR tablet by mouth every 24 hours for 12 weeks
  • 21 day titration: 1 mg/d (day 1-7); 2mgs/d (day 7-21)
  • Full dose: 3mgs/d (day 21- day 70)
  • 2 week taper: 2mgs/d (day 71-77); 1mg/d (day 77-83)

干预措施: Placebo (for guanfacine) (Drug)

结局指标

主要结局

Percentage of Days Abstinent

时间窗: 12 weeks

Percentage of days abstinent across the 12-week trial was calculated using the Timeline follow Back.

Percentage of Heavy Drinking Days

时间窗: 12 weeks

Percentage of heavy drinking days across the 12-week trial was calculated using the Timeline follow Back.

Alcohol Consumption (Percentage of Negative Urines)

时间窗: 12 weeks

Urine screening will be conducted twice per week across the trial.

次要结局

  • Mood (Depression)(2 times per week for 12 weeks)
  • Emotion Regulation (Difficulties in Impulse Control)(12-weeks)
  • Emotion Regulation (Limited Access to Emotion Regulation Strategies)(12-weeks)
  • Emotion Regulation (Difficulties With Emotional Awareness)(12-weeks)
  • Emotion Regulation (Non-Acceptance of Emotional Responses)(12-Week)
  • Mood (Anxiety)(2 times per week for 12 weeks)
  • Emotion Regulation (Difficulties With Engaging in Goal Related Behavior)(12-week)
  • Alcohol Craving(12-weeks)
  • Emotion Regulation (Difficulties With Emotional Clarity)(12-weeks)
  • Emotion Regulation (Total Score)(12-weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Helen Fox

Assistant Professor

Stony Brook University

研究点 (1)

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