NCT06803706 Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community
| NCT ID | NCT06803706 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sigmund Freud PrivatUniversitat |
| Condition | Substance Use Disorder (SUD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-05-05 |
| Primary Completion | 2026-10-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-05-05 with a primary completion date of 2026-10-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06803706 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Substance Use Disorder (SUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06803706 currently recruiting?
Yes, NCT06803706 is actively recruiting participants. Contact the research team at human.unterrainer@sfu.ac.at for enrollment information.
Where is the NCT06803706 trial being conducted?
This trial is being conducted at Fehring, Austria, Graz, Austria, Vienna, Austria.
Who is sponsoring the NCT06803706 clinical trial?
NCT06803706 is sponsored by Sigmund Freud PrivatUniversitat. The trial plans to enroll 150 participants.