High Dose Bupropion Treatment for Smoking Cessation - Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed]
研究概览
简要总结
This study aims to investigate the benefit of administering two differing doses of Bupropion (BUP) to smokers to assist with smoking cessation.
详细描述
Participants will be randomly assigned to either receive 300 mg of BUP or 450 mg of BUP for 8 weeks with an aim to quit smoking. In addition, participants will simultaneously receive counseling to set a quit date and stay motivated to quit. Medication will be administered up to 4 weeks before and for 4 weeks after designated quit-date. Post-treatment follow-up appointment will be scheduled for 8, 16, and 26 weeks post treatment to assess commitment to quitting and overall success of the study.
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
- Single (Participant)
盲法说明
Participants will be unaware of which medication condition they have been assigned to; however, the study team and the care provider will know which dose of medication they are distributing.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smokes cigarettes daily for at least 1 year
- •Breath CO of 5 ppm or higher at Baseline visit
- •Age 21 - 65
排除标准
- •Possible drug contraindications (panic disorder, bipolar disorder, bulimia, anorexia, insomnia, suicidal ideation, alcohol withdrawal, seizures, severe hypertension, renal/hepatic impairment, angle closure glaucoma)
- •Unstable cardiovascular disorder or uncontrolled hypertension
- •Severe renal/hepatic impairment based on serology evaluation
- •History of seizures, liver failure, central nervous system tumor, central nervous system infection, hypoglycemia, hyponatremia, hypoxia, stroke arteriovenous malformation, head injury
- •Current use of other cessation medication or counseling
- •History of bupropion use
- •Current anti-psychotic, anxiolytic, antidepressant, or psychostimulant medication use, other drugs that may lower seizure threshold, CYP2B6 inhibitors, CYP2B6 inducers, drug metabolized by CYP2D6
- •Sudden stoppage of alcohol, benzodiazepines, barbiturates, or antiepileptic drugs
- •Current (past 30 days) use of illicit or medical use of prescription stimulants
- •Currently or plan to be pregnant or breastfeeding
研究组 & 干预措施
BUP-300
Participants will receive Bupropion hydrochloride for 10 weeks and titrate to a maximum dose of 300 mg/day and will also receive standard smoking cessation counseling for 8 weeks.
干预措施: Bupropion Hydrochloride (Drug)
BUP-450
Participants will receive Bupropion hydrochloride for 12 weeks and titrate to a maximum dose of 450 mg/day and will also receive standard smoking cessation counseling for 8 weeks.
干预措施: Bupropion Hydrochloride (Drug)
结局指标
主要结局
Point Prevalence Abstinence (PPA) [change in abstinence reports will be assessed]
时间窗: Through study completion, an average of 26 months
Self report of smoking status
次要结局
- Inventory of Depressive and Anxious Symptomology (Traumatic intrusions subscale)(Through study completion, an average of 26 months)
- Snaithe-Hamilton Pleasure Scale (SHAPS)(Baseline visit and Week 8 post quit date)
- Inventory of Depressive and Anxious Symptomology (General depression subscale)(Through study completion, an average of 26 months)
- Self report scale for Attention deficit/Hyperactivity disorder (ADHD)(Baseline visit)
- Objective body weight(Baseline visit and Week 8 post quit date)
- Body adiposity via bioimpedence monitor(Baseline visit and Week 8 post quit date)
- Smoking cessation milestones(Through study completion, an average of 26 months)
- Inventory of Depressive and Anxious Symptomology (Social anxiety subscale)(Through study completion, an average of 26 months)
研究者
Adam Leventhal
Associate Professor
University of Southern California