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=100) will be conducted, examining outcomes such as clinical relapse rates, microbial and metabolic markers, particularly in choline and folate metabolism. Participants 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Held in the therapeutic community, the intervention will employ principles of cognitive-behavioural therapy (CBT) coupled with personalized recommendations for nicotine replacement. The Austrian Health Insurance standard for therapy will be guiding the program's content, which is tailored for inpatient clients. Specifically, the following interventions based on CBT techniques will be applied in the weekly group sessions consisting of 10 to 15 participants: Psychoeducation including information on tobacco addiction, health risks, advice on relapse prevention and the handling of craving, motivation building, behavioural observation.
The standard treatment within the 'Grüner Kreis' therapeutic community - which all participants will receive - consists of group therapy (once a week), individual psychotherapy (once a week), counselling by social workers, psychiatric consultations, as well as sport-, art- and work-therapy. Daily life is organized according to principles of therapeutic community-based addiction treatment.
Grüner Kreis Organization Johnsdorf Facility
Fehring, Austria
RECRUITINGMedical University Graz
Graz, Austria
RECRUITINGSigmund Freud Private University Vienna
Vienna, Austria
RECRUITINGSelf-efficacy
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.
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period
General substance-related craving
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.
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Tobacco dependence
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.
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Primary Affects
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.
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Metabolome
Metabolome will be ascertained from blood via state-of-the-art NMR (nuclear magnetic resonance).
Time frame: From enrollment to the end of the 6-weeks treatment period.
Gut microbiome
Gut microbiome will be ascertained via 16s-rRNA sequencing from stool.
Time frame: From enrollment to the end of the 6-weeks treatment period.
Smoking behaviour
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).
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Psychiatric Symptoms
For the evaluation of psychopathology, the ICD-10 Symptom Rating (ISR) questionnaire will be utilized. In accordance with the ICD-10, this self-assessment questionnaire, comprising 30 items, is designed to comprehensively assess the status and severity of mental disturbances. Symptoms of the six symptomatic patterns - depressive, anxiety, obsessive-compulsive, eating disorders, somatoform syndrome, and post-traumatic stress disorder - are assessed.
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.