Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Metabolome
研究概览
简要总结
Theoretical Framework: Cigarette smoking is the leading preventable cause of death worldwide, with nicotine dependence notably common among individuals with Substance Use Disorders (SUD). Smoking exacerbates both physical and mental health issues, further complicating the treatment of SUD. Current therapeutic approaches for SUD often prove inadequate, indicating a need for new strategies. Recent advancements in metabolomics and gut microbiome research have provided valuable insights into the biological mechanisms underlying addiction.
Objectives: This study aims to investigate the therapeutic potential of smoking cessation for individuals with SUD, using a six-week intervention within a therapeutic community. The research specifically explores the psychobehavioral, metabolic, and gut microbiome domains. It is hypothesized that smoking cessation will improve emotional regulation, self-efficacy, and reduce substance craving, mediated by changes in metabolic and microbiome profiles linked to brain reward systems.
Methods: A randomized controlled trial (N=150) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants with SUD (n=100) will undergo a six-week smoking cessation intervention, with pre- and post-assessments, compared to a control group receiving treatment as usual. Metabolomic and microbiome analyses will be conducted using blood and stool samples, alongside psychological assessments via questionnaires. Assessments on a behavioural level will take place at a 3-months follow-up.
A cross-sectional, non-interventional healthy control group (n=50) will be examined at a single timepoint with an anologous panel of psychological variables, blood and stool to ascertain differences between smokers with SUD and healthy controls.
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
- 是
入选标准
- •diagnosis of a form of substance use disorder (F1x.x) by a licensed psychiatrist according to ICD-10
- •minimum age of 18 years
- •sufficient knowledge of the German language
- •willingness to quit smoking
- •willingness and ability to consent
- •Inclusion criteria for healthy controls :
- •minimum age of 18 years
- •sufficient knowledge of the German language
- •willingness and ability to consent
排除标准
- •lack of consent, inability to provide informed consent
- •age below 18,
- •acute psychotic symptoms or acute suicidal tendencies
- •cardiovascular disease
- •pregnancy or breastfeeding
- •severe mental or organic illnesses (such as epilepsy, brain tumors, recent major surgery), tumor diseases, dementia (Mini Mental Score <20), severe autoimmune diseases or immunosuppression, acute infections, or acute diarrhea, prior gastrointestinal surgery (except appendectomy)
- •probiotic intake within the last 6 months,
- •ongoing consumtion of dietary supplements, probiotics, antibiotics, or prebiotic supplements during the study
- •prior participation in a smoking cessation programme
研究组 & 干预措施
6-weeks smoking cessation cognitive-behavioral therapy intervention
The "smoke free in 6 weeks" program is a standardized behavioural therapy intervention that takes place once a week for 1.5 hours over 6 weeks and is provided by the Austrian health insurance provider Österreichische Gesundheitskasse (ÖGK).
干预措施: Long-term drug therapy within a therapeutic community (Behavioral)
Treatment As Usual
Patients in the TAU group receive long-term rehabilitation drug treatment according to the 'community as a treatment'-model
干预措施: Long-term drug therapy within a therapeutic community (Behavioral)
6-weeks smoking cessation cognitive-behavioral therapy intervention
The "smoke free in 6 weeks" program is a standardized behavioural therapy intervention that takes place once a week for 1.5 hours over 6 weeks and is provided by the Austrian health insurance provider Österreichische Gesundheitskasse (ÖGK).
干预措施: 6-weeks CBT smoking cessation programme (Behavioral)
Healthy controls
Control group with n=50 healthy adult subjects, examined at a single timepoint. No interventions will be administered in this arm.
结局指标
主要结局
Metabolome
时间窗: From enrollment to the end of the 6-weeks treatment period.
Metabolome will be ascertained from blood via state-of-the-art NMR (nuclear magnetic resonance).
Self-efficacy
时间窗: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period
Self-efficacy as a psychological variable and will be assessed by the Self-Efficacy Scale (SWE), a self-report instrument for measuring general optimistic self-confidence. It consists of 10 items and measures optimistic competence expectancy, i.e., confidence in solving difficult situations with one's own abilities.
General substance-related craving
时间窗: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Substance related craving will be assessed by the MaCS (Mannheim Craving Scale). consists of 12 items and four additional items and is rated on a 5- point Likert scale.
Tobacco dependence
时间窗: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Tobacco dependence will be assessed by The Fagerström Test for Cigarette Dependence (formerly Fagerström Test for Nicotine Dependence; FTND). It consists of 6 categorically scaled items that assess the number of smoked cigarettes per day (CPD), compulsive use, and dependence intensity.
Primary Affects
时间窗: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Primary Affects, as proposed by Jaak Panksepp will be assessed by the German Version of the Brief Affective Neuroscience Personality Scales including a LUST Scale (BANPS-GL), a self-report questionnaire.
Gut microbiome
时间窗: From enrollment to the end of the 6-weeks treatment period.
Gut microbiome will be ascertained via 16s-rRNA sequencing from stool.
Smoking behaviour
时间窗: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Participants will be asked regarding their daily smoked cigarettes in the last two weeks (interval scaled). A second single item question will be, if participants have been completely abstinent from tobacco smoking in the last two weeks (dichotome).
次要结局
- Psychiatric Symptoms(From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.)