Guanfacine for Alcohol Use Disorder (AUD)

Официальное название

Guanfacine for Alcohol Use Disorder (AUD): a Telehealth Approach

Обзор

The investigators assess whether guanfacine extended release (GXR; 3mg/d) compared with placebo (PBO) will attenuate drinking and drinking-related factors in N=200 men and women with Alcohol Use Disorder (AUD) across 12-weeks.

Подробное описание

This is a study to examine the efficacy of guanfacine extended release (GXR) (3mg/d) compared with placebo (PBO) in reducing drinking in N=200 men and women with Alcohol Use Disorder (AUD). The study will be conducted across two sites for 12-weeks. Indiana University will be the primary site and Rutgers University, the secondary site. Participants at both sites will be randomized to either GXR (3mg/d) or placebo (PBO), and titrated to full dose over a three week period. After remaining at full dose for 7 weeks a two week schedule will be used to taper participants off the medication. During the study the investigators will collect brief reports throughout the day and evening of drinking severity, stress, craving, mood, arousal, anxiety, and emotion regulation at weeks 1 and 2 (baseline) and weeks 5 and 6 (steady state). Additionally, blood alcohol concentration (BAC) levels will be collected three times per day for the full 12-weeks. Daily encrypted video recordings will be used to monitor medication compliance, and participants will also take part in twice weekly remote visits to assess safety, vitals, collect urines, monitor alcohol use, and receive weekly Medical Management. It is anticipated that guanfacine will demonstrate greater efficacy in women compared to men with AUD.

Вмешательства

• Препарат Guanfacine Extended Release (XR)
  3mg tablet once daily
• Препарат Placebo
  placebo tablet once daily

Первичные конечные точки

• Change in % number of days drinking [Срок оценки: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12]
• Change in Blood Alcohol Concentration (BAC) levels [Срок оценки: three times per day through week 12.]
• Change in no. of drinks consumed following stress [Срок оценки: five times daily during weeks 1, 2, 5, 6]
• Change in alcohol craving following stress [Срок оценки: five times daily during weeks 1, 2, 5, 6]

Вторичные конечные точки (6)

• Change in number of drinks consumed per occasion [Срок оценки: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12]
• Change in number of binge episodes [Срок оценки: five times daily during weeks 1, 2, 5, 6 and twice weekly through week 12]
• Change in negative mood following stress [Срок оценки: five times daily during weeks 1, 2, 5, 6]
• Change in anxiety following stress [Срок оценки: five times daily during weeks 1, 2, 5, 6]
• Change in arousal following stress [Срок оценки: five times daily during weeks 1, 2, 5, 6]
• Change in emotion regulation following stress [Срок оценки: five times daily during weeks 1, 2, 5, 6]

Критерии участия

Критерии включения

• be assigned as a biological male or female at birth and identify as such
• meet current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) criteria for moderate to severe AUD
• be ≥18 years old and have a body mass index (BMI) of 18-35
• express a desire to quit alcohol as determined by the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
• demonstrate a positive urine for alcohol on admission to study procedures
• be able to provide informed verbal and written consent
• be able to read English and complete study evaluations
• be in good health as verified by the intake 1 physical examination

Критерии исключения

• meet criteria for moderate to severe Substance Use Disorder (SUD), excluding alcohol and nicotine
• have a positive screen for substances of abuse, excluding alcohol, nicotine,
• being psychotic or otherwise severely psychiatrically disabled (including suicidal, homicidal, current mania)
• meet criteria for physiological dependence on alcohol requiring medical detoxification
• regular use of medications in the last 6 months that, in the opinion of the site physician may be contraindicated with GXR and be potentially harmful to the participant
• be pregnant or breast feeding
• be using monophasic contraceptives
• have cardiovascular disease including high blood pressure,
• be hypotensive with sitting blood pressure below 100/50 mmHG
• have bradycardia with a sitting heart rate (HR) of <60 bpm
• show EKG evidence of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) >470 msec for women and QTc>450 msec for men.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• The Stark Neuroscience Building (Goodman Hall) — Indianapolis
• Rutgers School of Health Professionals — Newark

Идентификаторы

NCT: NCT06629259 · 24432 · R01AA031662-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗