Testing the GABAergic Hypothesis of Nicotine Dependence: a Randomized Clinical Trial of Baclofen
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Smoking abstinence for 7 days at end of treatment
研究概览
简要总结
The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures.
The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i.e. take the medication as directed for the trial period) than those in the placebo group.
The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.
详细描述
This study will test a new medication strategy designed to help smokers quit. It will evaluate Baclofen, a drug currently approved and available in Canada as a myorelaxant. Forty five nicotine-dependent smokers will enroll in this study. Fifteen will receive placebo (inactive pill), fifteen will receive baclofen 30 mg/day, and fifteen will receive baclofen 60 mg/day. Once enrolled, subjects will visit CAMH on a weekly basis for assessment of smoking behaviour, a brief health check (vitals, BP and AE screening), delivery of brief individual smoking cessation counselling, and collection of breath, blood and urine samples (as scheduled) to a) measure levels of nicotine and its metabolites, b) conduct pregnancy and tox testing. The medication phase of this study lasts 12 weeks. Two follow-up visits will be scheduled at week 13 and at six months after trial completion.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults (18 years or older).
- •Meet DSM-IV criteria for nicotine dependence,
- •Smoke ≥10 cigarettes/day,
- •Baseline FTND score ≥4, CO level ≥10,
- •have had at least one failed quit attempt in the past and are motivated to quit within 30 days of initial intake.
- •No previous use of medication for smoking cessation in 1 month prior to randomization.
- •BMI between 15 and 40 inclusive.
排除标准
- •Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder, or a current or past history of bipolar disorder or schizophrenia
- •Have a past history of major depression, with historical evidence of suicidal or homicidal behaviour, or psychotic symptom,
- •Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 3 months prior to randomization
- •Demonstrate serious medical conditions, unstable cardiovascular disease, significant blood abnormalities)
- •Are pregnant, are trying to become pregnant or are currently breastfeeding
- •Baclofen hypersensitivity .
研究组 & 干预措施
Baclofen 30 mg/day
Baclofen medication
干预措施: Baclofen 30 mg/day (Drug)
Placebo pill
placebo pill
干预措施: placebo pill (Drug)
Baclofen 60 mg/day
Baclofen medication high dose
干预措施: Baclofen 60 mg/day (Drug)
结局指标
主要结局
Smoking abstinence for 7 days at end of treatment
时间窗: end of treatment week 10
At end of treatment subjects will report smoking consumption for past 7 days. Subject are considered abstinent based on self report and verfied by CO level (\<10 PPM)
Abstinent rate: last four weeks of trial
时间窗: last 4 weeks of trial (week 7 to 10)
subjects report cigarette consumption during the last 4 weeks of the clinical trial. abstinence rates are verifed by CO \< 10 PPM
abstinence rate: for past 7 days at 6 month followup
时间窗: 6 month followup
Subject are asked to attend a 6 month followup. At this time subjects will be asked to report their cigarette consumption for the past 7 days. abstinence is based on this self report and verified by CO levels \<10 PPM
次要结局
- Tiffany Questionnaire of Smoking Urges(screen, week 1,4,7,10, abd 6 month followup)
- Minnesota Nicotine Withdrawal Scale(Screen, week 1,4,7,10 and 6 month followup)
研究者
Bernard Le Foll
Prinicipal Investigator
Centre for Addiction and Mental Health