NCT00000447已完成4 期
Behavioral/Pharmacological Treatments for Alcohol-Nicotine Dependence
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 1998年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
研究概览
简要总结
This study will develop a behavioral and drug relapse prevention program for individuals who are dependent on both alcohol and tobacco. The study's goal is to show that individuals receiving nicotine replacement therapy and naltrexone (Revia) with behavior therapy will have higher rates of abstinence from both smoking and drinking than individuals who do not receive the drug therapies. Individuals will be placed in a 12-week outpatient treatment program with followup assessments 1, 3, and 6 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets criteria for alcohol and nicotine dependence.
- •Individuals will be outpatients with alcohol and nicotine dependence who have completed detoxification (medicated or nonmedicated) within the past 48-120 hours.
- •Smoking no less than 10 cigarettes/day and no greater than 50 cigarettes/day.
- •Motivated to quit smoking.
- •Willing and able to participate in the 12 week outpatient treatment.
- •Acceptable health.
- •Able to provide a collateral informant.
- •Willing to be followed for 6 months after treatment ends.
- •Willing and able to provide the names of three family members or friends to aid in locating participants for follow-up.
排除标准
- •Current diagnosis of dependence on other substances except nicotine and alcohol.
- •Having moderately severe or severe alcohol withdrawal symptoms.
- •Recent (less than 48 hours) evidence of hazardous drinking (more than 2 drinks/day for females; 3 drinks/day for males).
- •History of opioid abuse.
- •Recent use of cocaine.
- •Not desiring to quit smoking.
- •Recent past or current pharmacotherapy involving naltrexone or transdermal nicotine systems.
- •History of psychosis.
- •Current suicidality, homicidally or psychiatric symptoms requiring other medications.
- •Presence of medical abnormalities that contraindicate naltrexone or nicotine replacement therapy.
- •Current treatment with psychotropic medications.
- •Pregnancy or nursing for female patients. Inability or unwillingness to participate in the 12-week outpatient treatment.
研究者
研究点 (2)
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