Phase II Randomized, Double-Blind Trial of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Likelihood of progression to a relapse (e.g., return to baseline smoking) following a slip at any time in study.
研究概览
简要总结
The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit.
详细描述
The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit. Bupropion is an FDA-approved medication for smoking cessation that is believed to provide relief from craving and withdrawal through promotion of two neurotransmitter chemicals, dopamine and noradrenaline. Naltrexone is an FDA-approved medication for the treatment of opiate and alcohol dependence, that appears to function through blocking certain opiate receptors in the brain. It is expected that bupropion + naltrexone will produce higher smoking quit rates than bupropion + placebo. Bupropion alone is effective in alleviating some nicotine withdrawal complaints and craving for nicotine. However, bupropion does not reduce the rewarding effects of slips to smoking. Naltrexone alone is not generally effective as a smoking cessation medication, but it does help to reduce the rewarding effects of slips to smoking. Thus, it may help to prevent full relapse to smoking. In addition, naltrexone can help to reduce craving for cigarettes. It is hypothesized that the differing complementary actions of the two drugs will help smokers more than bupropion alone. In addition to examining smoking quit rates, the proposed study will also look at psychological processes that change during smoking cessation including, nicotine withdrawal, nicotine craving, mood, impulsivity, and attention
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years and older.
- •Smoked at least 10 cigarettes/day for at least 1 year.
- •English speaking.
- •Females who are of childbearing potential must practice effective contraception and meet the following criteria:
- •Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
- •Have a negative urine pregnancy test at baseline.
- •Agree to use of the birth control methods listed: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use through at least 30 days after the last dose of the study medication. A barrier method of contraception (e.g., condom or diaphragm with spermicide) while participating in the study and 30 days after the last dose of study medication.
- •Willingness to reduce alcohol consumption during study to 2 or fewer standard drinks/day (3 oz. of alcohol or two beers (12 oz.), or two 5 oz. glasses of wine).
- •Willingness to not use illicit drugs during study period including marijuana.
排除标准
- •Concurrent use of tobacco products (other than cigarettes) or nicotine products.
- •Contraindications to use of bupropion (i.e., concurrent use of other forms of bupropion, MAO inhibitors, anti-depressant medication, seizure disorder or any clinical situation that might increase risk for seizures, past head injury, current or prior diagnosis of bulimia or anorexia nervosa; bipolar disorder).
- •Contraindications to use of naltrexone (i.e., past history of opioid abuse or dependence or evidence of opioid use in the past 30 days; significant hepatocellular injury as evidenced by liver enzyme levels over 3 times normal limits).
- •Use of medications whose metabolism or effects may be adversely altered by bupropion or naltrexone. Medications that contraindicate the use of bupropion include theophylline, procarbazine, carbimazole, nialamide, pargyline, toloxatone, iproniazid, and systemic steroids. Medications that contraindicate the use of naltrexone include opioid analgesics and yohimbine.
- •Current use of anti-seizure medications, disulfiram, or any medications that significantly challenge liver functioning.
- •Treatment for drug or alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol.
- •Evidence of problem alcohol consumption based on AUDIT.
- •Self-reported use of illicit drugs in the past 90 days (including opioids, but excluding marijuana).
- •Suicidal or homicidal ideation.
- •Current major depression.
- •History of bipolar disorder.
- •Recent (within twelve months) myocardial infarction.
- •Pregnant or lactating or planning pregnancy during treatment period.
- •Having plans to leave the immediate geographical area within 9 months.
- •Unwillingness or inability to given written informed consent.
研究组 & 干预措施
1
Bupropion+Placebo
干预措施: Bupropion (Drug)
2
Bupropion+Naltrexone
干预措施: Bupropion + Naltrexone (Drug)
结局指标
主要结局
Likelihood of progression to a relapse (e.g., return to baseline smoking) following a slip at any time in study.
时间窗: At any point following the quit date.
Treatment completion.
时间窗: Weeks 7 and 30.
Daily cigarette smoking rate.
时间窗: Weekly
Frequency and severity of bupropion and naltrexone side effects.
时间窗: Weekly during treatment
Biochemically-verified point-prevalence abstinence
时间窗: 7, 11, 16, and 30 weeks post-quit
次要结局
- Attentional bias.(Weeks 1, 3, and 7.)
- Impulsivity.(Weeks 1, 3, and 7.)
- Nicotine withdrawal, craving and negative/positive affect.(All visits.)