Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-cessation Weight Gain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Weight Gain at 26 Weeks.
研究概览
简要总结
Weight gain after quitting smoking is an important barrier to treatment for many smokers. This study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain.
详细描述
This is a 6-month randomized, double-blind, placebo controlled trial of 25 mg naltrexone for smoking cessation in a sample of 270 male and female weight-concerned smokers. Participants also receive transdermal nicotine replacement therapy during the first 8 weeks of the study, which they begin on their quit date. Naltrexone study medication will be started a week before their quit date and continued through the six-month period. Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter. A follow-up appointment is completed at 12 months after participants' quit date.
The primary outcomes are six-month point prevalence abstinence and post-cessation weight gain for those who are continuously abstinent (not even a puff).
Secondary outcomes include an examination of alcohol consumption, evaluation of urges, other measures of smoking cessation success, point prevalence abstinence at 12 months, and food preferences. A number of tertiary measures will be obtained for examining predictors of smoking cessation, weight gain, and naltrexone response.
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •Concern about gaining weight after quitting. This will be assessed using questionnaires that will provide a rating system to determine qualified participants.
- •Age 18 and older.
- •Willingness and ability to give written consent.
- •Smoking greater than 10 cigarettes per day for at least 1 year.
- •At least one prior attempt to stop smoking.
- •Baseline expired carbon-monoxide level of at least 10 ppm.
- •Weigh at least 100 lbs.
- •English speaking.
- •One person per household.
排除标准
- •Pregnant or nursing women or women attempting to conceive.
- •Unstable cardiac disease.
- •History of dermatoses.
- •Current alcohol or drug dependence other than nicotine dependence.
- •Serious current neurologic, psychiatric or medical illness, including those with a significant risk of committing suicide based on history or investigator's judgment.
- •Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist, will make these medications ineffective).
- •History of cirrhosis or significant hepatocellular injury as evidenced by SGOT or SGPT >3 x normal or elevated bilirubin.
- •Current use of smokeless tobacco, pipes, cigars, nicotine gum, patch, nasal spray, inhaler, or lozenges.
- •Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component except those who are on a stable dose of an Selective Serotonin Reuptake Inhibitor for at least two months for the indications of Major Depressive Disorder, Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD).
- •Subjects with a positive opiate urine drug screen will be excluded to avoid precipitating opiate withdrawal.
- •Current use of opiates.
- •Currently on a medically prescribed diet.
研究组 & 干预措施
Naltrexone, Transdermal Nicotine
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
干预措施: Naltrexone (Drug)
Naltrexone, Transdermal Nicotine
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
干预措施: Transdermal nicotine replacement (Drug)
Naltrexone, Transdermal Nicotine
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
干预措施: Behavioral counseling (Behavioral)
Placebo Naltrexone, Transdermal Nicotine
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
干预措施: Transdermal nicotine replacement (Drug)
Placebo Naltrexone, Transdermal Nicotine
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
干预措施: Behavioral counseling (Behavioral)
结局指标
主要结局
Weight Gain at 26 Weeks.
时间窗: 26 weeks
Weight change from baseline measured at 26 weeks.
Point Prevalence Smoking Abstinence at 26 Weeks.
时间窗: 26 weeks
The number of people that were abstinent from cigarette smoking at 26 weeks.
次要结局
- Weight Gain at 6 Weeks.(6 weeks)
- Point Prevalence Smoking Abstinence at 6 Weeks(6 weeks)
- Cigarettes Smoked Per Day.(26 weeks)