Guanfacine Extended-release Randomised Controlled Trial for Adolescents With Cannabis usE (GRACE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy - change from baseline in cannabis use frequency following monitored abstinence
研究概览
简要总结
A randomized controlled trial to assess the efficacy of extended-release guanfacine to reduce cannabis use frequency in young people with cannabis use disorder following a period of monitored abstinence.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-25 years of age (inclusive) at consent;
- •Seeking treatment for cannabis use;
- •DSM-5 Cannabis Use Disorder, mild, moderate or severe;
- •Self-reported cannabis use on average at least 5 days/week during the 28 days prior to screening with a THC positive urine drug screen on the day of screening; and
- •Able to provide informed consent (both adequate IQ and English fluency; <18-year-olds will provide consent themselves in addition to parent/guardian consent).
排除标准
- •DSM-5 substance use disorder (moderate or severe) except cannabis or nicotine;
- •Any unstable medical, psychiatric or neurological condition or medical contraindicating study participation;
- •Diagnosis of a psychotic or bipolar illness;
- •Acute suicidality as assessed by clinician;
- •Prescribed antipsychotics, benzodiazepines or other sedative medications, or other medications for the treatment of ADHD. If prescribed antidepressants, the participant must have been on a stable dose for more than 2 weeks at screening;
- •A history of heart disease or cardiac risk factors (e.g. arrhythmias);
- •Abnormal liver or thyroid function as indicated by clinically-significant findings on blood tests;
- •Pregnancy, breast feeding or, if sexually active and able to become pregnant, no effective contraception.
- •Intention to enter residential rehabilitation after treatment in the YSAS residential withdrawal facility.
研究组 & 干预措施
Placebo
Placebo once daily for approximately 12 weeks plus treatment as usual
干预措施: Residential withdrawal (Behavioral)
Guanfacine extended-release
Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual
干预措施: Guanfacine Extended Release Oral Tablet (Drug)
Guanfacine extended-release
Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual
干预措施: Residential withdrawal (Behavioral)
Guanfacine extended-release
Guanfacine extended-release (target dose 4 mg), once daily for approximately 12 weeks plus treatment as usual
干预措施: Engagement with alcohol and other drug services (Behavioral)
Placebo
Placebo once daily for approximately 12 weeks plus treatment as usual
干预措施: Engagement with alcohol and other drug services (Behavioral)
Placebo
Placebo once daily for approximately 12 weeks plus treatment as usual
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy - change from baseline in cannabis use frequency following monitored abstinence
时间窗: Baseline and weekly in the 4 week outpatient phase immediately following discharge from residential withdrawal
Change from baseline in average frequency of cannabis use (days of use/week) in the 4 weeks immediately following discharge from residential withdrawal, assessed weekly using the Timeline Follow-Back.
次要结局
- Change from baseline in cannabis use frequency following monitored abstinence (categorical)(Baseline and weekly in the 4 weeks immediately following discharge from residential withdrawal)
- Sleep quality (subjective) during residential withdrawal admission(Daily during residential treatment for 4 to 14 days)
- Sleep quality (objective) during residential withdrawal admission(Daily during residential treatment for 4 to 14 days)
- Food intake during residential withdrawal admission(Daily during residential treatment for 4 to 14 days)
- Treatment engagement (outpatient)(Baseline to end of treatment)
- Change from baseline in daily functioning - social inclusion(Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal))
- Change from baseline in cannabis use disorder symptoms(Baseline and end of Maintenance phase (4 weeks post discharge from residential withdrawal))
- Treatment engagement (residential)(Baseline to end of treatment)
- Change from baseline in daily functioning - social and occupational(Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal))
- Change from baseline in daily functioning - multidimensional(Baseline and end of maintenance period assessments (4 weeks post discharge from residential withdrawal))
- Cannabis exposure(Approximately weekly between Baseline (week 0) and the end of treatment visit (week C7), approximately 12 weeks from baseline)
- Cannabis withdrawal symptoms during residential withdrawal admission(Daily during residential treatment for 4 to 14 days)
- Cannabis craving during residential withdrawal admission(Daily during residential treatment for 4 to 14 days)