Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Continuous Abstinence at 12 Weeks Post Target Quit Date
研究概览
简要总结
The major purpose of this exploratory developmental study will be to develop a patient-centered and feasible protocol for communicating genetic data as it relates to drug efficacy for smoking cessation inpatients receiving medication that is matched to individual genotypes associated with increased efficacy for bupropion or nicotine replacement therapy.
详细描述
Therefore, our specific aims are to:
Aim 1: Conduct formative research to develop and refine a clinical protocol for a multi-component smoking cessation intervention, grounded in the extended parallel process model, consisting of pharmacogenetic treatment (smoking cessation drug matched to each individual smoker's genotype) and genetic feedback (delivery of patient-centered, personalized genotype information and its predictive value for smoking cessation treatment efficacy): We will adapt, pilot-test, and refine a theoretically-grounded PGx smoking cessation intervention using formative interviews of 20 African-American and European-ancestry smokers.
Aim 2: Conduct a mixed-methods feasibility trial randomizing treatment-seeking smokers to pharmacogenetic (PGx) treatment combined with genetic feedback (GF) vs. PGx treatment without GF for smoking cessation to examine the feasibility of the newly developed protocol in a primary care setting and characterize its psychological and behavioral impact: Smokers (N = 100) will be randomized to GF vs. no GF and all will receive motivational interviewing (standard care/SC) and PGx treatment. We will assess the impact of GF on time to relapse, medication adherence, and a comprehensive assessment battery of process and cognitive, psychological, and behavioral outcomes. Finally, we will synthesize quantitative and qualitative data to revise protocols, generate hypothesizes, and estimate effect sizes for a follow-up R01 submission.
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
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard treatment
-
Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling.
-
A self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
-
A standard 8-week course of genetically-tailored pharmacotherapy
-
Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch)
-
Participants with the A2 allele (CC) were assigned to receive bupropion
干预措施: Counseling (Behavioral)
Standard treatment
-
Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling.
-
A self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
-
A standard 8-week course of genetically-tailored pharmacotherapy
-
Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch)
-
Participants with the A2 allele (CC) were assigned to receive bupropion
干预措施: Self-help guide (Behavioral)
Standard treatment
-
Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling.
-
A self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
-
A standard 8-week course of genetically-tailored pharmacotherapy
-
Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch)
-
Participants with the A2 allele (CC) were assigned to receive bupropion
干预措施: Pharmacotherapy (Drug)
Genetic feedback plus standard treatment
In addition to the standard treatment, participants in this arm received the following interventions:
- Genetic feedback, verbal - During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
- Genetic feedback, printed - After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype
干预措施: Counseling (Behavioral)
Genetic feedback plus standard treatment
In addition to the standard treatment, participants in this arm received the following interventions:
- Genetic feedback, verbal - During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
- Genetic feedback, printed - After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype
干预措施: Self-help guide (Behavioral)
Genetic feedback plus standard treatment
In addition to the standard treatment, participants in this arm received the following interventions:
- Genetic feedback, verbal - During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
- Genetic feedback, printed - After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype
干预措施: Pharmacotherapy (Drug)
Genetic feedback plus standard treatment
In addition to the standard treatment, participants in this arm received the following interventions:
- Genetic feedback, verbal - During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
- Genetic feedback, printed - After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype
干预措施: Genetic feedback, verbal (Behavioral)
Genetic feedback plus standard treatment
In addition to the standard treatment, participants in this arm received the following interventions:
- Genetic feedback, verbal - During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
- Genetic feedback, printed - After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype
干预措施: Genetic feedback, printed (Behavioral)
结局指标
主要结局
Continuous Abstinence at 12 Weeks Post Target Quit Date
时间窗: 12 weeks after Target Quit Date
Participants reporting continuous tobacco-use abstinence 12 weeks after their Target Quit Date, whose salivary cotinine levels confirmed their abstinence, were counted as "abstinent." All others were recorded as not abstinent.
次要结局
- Morisky Adherence Scale(12 weeks after Target Quit Date)
- Trust Scale(Within 1 week of first clinical call)
- Communication Scale(Within 1 week of first clinical call)
- Satisfaction Scale(Within 1 week of first clinical call)
- Treatment Interest Scale(Within 1 week of first clinical call)
- Depression(Within 1 week of first clinical call)
- Fatalism(12 weeks after Target Quit Date)
- Intention to Quit(Within 1 week of first clinical call)
- Motivation(Within 1 week of first clinical call)
- Perceived Control(Within 1 week of first clinical call)
- Risk Perception(Within 1 week of first clinical call)
- Self-Efficacy(Within 1 week of first clinical call)
- Threat Minimization(Within 1 week of first clinical call)