Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community
Key facts
- Who runs it
- Sigmund Freud PrivatUniversitat
- Where
- Austria3 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 97 people enrolled
- Started
- 5 May 2025
- Ended
- 18 Sept 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- 6-weeks CBT smoking cessation programme
- Long-term drug therapy within a therapeutic community
- Record updated
- 29 September 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- 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
- minimum age of 18 years
- sufficient knowledge of the German language
- willingness and ability to consent
Who cannot take part
- 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)
- prior participation in a smoking cessation programme
- cardiovascular disease
- age below 18,
- lack of consent, inability to provide informed consent
- acute psychotic symptoms or acute suicidal tendencies
- pregnancy or breastfeeding
- probiotic intake within the last 6 months,
- ongoing consumtion of dietary supplements, probiotics, antibiotics, or prebiotic supplements during the study
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The 3 groups in the trial
- Treatment As UsualExisting treatment, for comparison
Patients in the TAU group receive long-term rehabilitation drug treatment according to the 'community as a treatment'-model
Treatment: Long-term drug therapy within a therapeutic community
- 6-weeks smoking cessation cognitive-behavioral therapy interventionTreatment being tested
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).
Treatment: 6-weeks CBT smoking cessation programme and Long-term drug therapy within a therapeutic community
- Healthy controlsNo study treatment, for comparison
Control group with n=50 healthy adult subjects, examined at a single timepoint. No interventions will be administered in this arm.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: A Randomized Controlled Trial
- Publications
- Record updated
- 29 September 2026