Treatment of Smoking Among Individuals With PTSD: A Phase II, Randomized Study of Varenicline and Cognitive Behavioral Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Number of Participants With 7-day Point Prevalence Smoking Abstinence
研究概览
简要总结
This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up.
We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.
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 (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
- 否
入选标准
- •Male or female treatment-seeking cigarette smokers between 18-75 years old who smoke an average of ≥10 cigarettes/day during past year;
- •Current diagnosis of chronic PTSD (symptom duration > 3 months) with clinically significant trauma-related symptoms (PSS-I >= 20)
- •Live a commutable distance to the University of Pennsylvania and agree to follow-up visits;
- •Agree not to use other forms of smoking cessation treatment or treatment for PTSD during the study period;
- •If taking SRIs or other medications at intake, have been on stable medication and dose regimen for past 3 months and agree to maintain current regimen if possible;
- •Demonstrate the capacity to provide informed consent;
- •Speak and read English.
排除标准
- •History of drug or alcohol abuse or dependence in past 3 months or any unwillingness to not smoke marijuana during the first 13 weeks of the study;
- •Current and continuing intimate relationship with a physically or sexually abusive partner;
- •Current suicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment;
- •Prior serious suicide attempt, as judged by the evaluator to have a high degree of lethality;
- •Current or past history of psychosis (bipolar disorder or schizophrenia);
- •History of significant cardiovascular disease or uncontrolled hypertension in past 6 months;
- •Women who are pregnant, likely to become pregnant (i.e., sexually active and not using contraception), or nursing.
研究组 & 干预措施
Integrated Treatment
Prolonged Exposure + Varenicline + Medication Management Counseling
干预措施: Varenicline (Drug)
Integrated Treatment
Prolonged Exposure + Varenicline + Medication Management Counseling
干预措施: Medication Management Counseling (Behavioral)
Integrated Treatment
Prolonged Exposure + Varenicline + Medication Management Counseling
干预措施: Prolonged Exposure (Behavioral)
Varenicline
Varenicline + Medication Management Counseling
干预措施: Varenicline (Drug)
Varenicline
Varenicline + Medication Management Counseling
干预措施: Medication Management Counseling (Behavioral)
结局指标
主要结局
Number of Participants With 7-day Point Prevalence Smoking Abstinence
时间窗: At 3-month follow-up (6-month post-quit day)
Number of participants reporting seven-day point prevalence abstinence (PPA), which was defined as self-reported abstinence for 7 days prior to the assessment, serum cotinine level of \<15ng/ml, and CO \< 10 ppm.
次要结局
- Blood Serum Cotinine(At end of 3-month follow-up)
- TLFB - Total Cigarettes Smoked Week Before Appointment (at Post-Treatment)(Week before Post-Treatment visit occurring at week 12, i.e. number of cigarettes smoked for the week prior to this week 12 visit)
- Posttraumatic Symptom Scale Interview (PSS-I) Total Score at 3-Month Follow-Up(3-month follow-up)
- Hamilton Depression Scale (HAM-D) Total Score at Post-Treatment(Post-Treatment assessment, occurring 12 weeks after the start of treatment (week 0))
- Hamilton Depression Scale (HAM-D) Total Score at 3-Month Follow-Up(3-month follow-up)
- TLFB - Cigarettes Smoked Week Before 3-Month Follow-up(3-month follow-up)
- Posttraumatic Symptom Scale Interview (PSS-I) at Post-Treatment(Post-treatment, occurring 12 weeks after the start of treatment (week 0))