Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Smoking Abstinence
研究概览
简要总结
The purpose of the current study is to evaluate the efficacy of d-cycloserine in augmenting treatment of smoking cessation for individuals with panic attacks. The investigators hypothesize that individuals receiving DCS (versus those receiving placebo) will evidence greater smoking abstinence rates and decreased panic symptoms after receiving a combined CBT-based treatment for smokers with panic attacks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients ages 18-65 capable of providing informed consent
- •Willing and able to provide informed consent, attend all study visits and comply with the protocol
- •Daily smoker for at least one year
- •Currently smoke an average of at least 8 cigarettes per day
- •Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
- •Evidence of panic attack within the past year and endorsement of smoking as an emotion regulation strategy (i.e., score at least a 78 on the SAEQ).
排除标准
- •Subjects who do not use smoking as an emotion regulation strategy
- •Current diagnosis of a psychotic, eating, developmental or bipolar disorder
- •Significant suicide risk as determined by structured interview
- •Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
- •Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
- •Current use of isoniazid or ethionamide compounds
- •A history of significant medical condition and/or be deemed as currently unhealthy in the context of a complete physical examination
- •Limited mental competency and the inability to give informed, voluntary, written consent to participate
- •Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt
- •Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of anxiety or mood disorder other than general supportive therapy initiated at least 3 months prior to the study
- •Use of other tobacco products
- •Plans to move outside of the immediate area in the next six months
- •Insufficient command of the English language
研究组 & 干预措施
PSRT_DCS
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
干预措施: d-cycloserine (Drug)
PSRT_DCS
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
干预措施: Nicotine replacement therapy (Drug)
PSRT_DCS
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill of d-cycloserine (DCS) one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
干预措施: Panic and Smoking Reduction Treatment (Behavioral)
PSRT_PBO
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
干预措施: Pill Placebo (Drug)
PSRT_PBO
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
干预措施: Nicotine replacement therapy (Drug)
PSRT_PBO
Individuals in this condition will receive 7 weeks of panic and smoking reduction treatment (PSRT) and one pill placebo dose one hour prior to sessions 3, 4, and 5 (i.e., 3 single doses). Participants will also be given nicotine replacement therapy as part of PSRT (i.e., the patch).
干预措施: Panic and Smoking Reduction Treatment (Behavioral)
结局指标
主要结局
Smoking Abstinence
时间窗: Assessed from week 3-29, week 29 reported
Smoking status will be assessed at baseline and each of the follow-up assessments using point prevalence abstinence (PPA) measures verified with carbon monoxide and saliva cotinine.
次要结局
- Panic Symptoms Mechanistic Target(Assessed from week 3-29, week 29 reported (6-month follow-up))
- Anxiety Sensitivity Mechanistic Target(Assessed from week 3-29, week 7 reported (end of treatment))
研究者
Jasper A. Smits
Principal Investigator
University of Texas at Austin