Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community
Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: A Randomized Controlled Trial
1 other identifier
interventional
100
1 country
3
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=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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2025
CompletedFirst Posted
Study publicly available on registry
January 31, 2025
CompletedStudy Start
First participant enrolled
May 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 28, 2026
March 25, 2026
March 1, 2026
1.5 years
January 23, 2025
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Self-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.
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.
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.
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.
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).
From enrollment to the end of the 6-weeks treatment period.
Gut microbiome
Gut microbiome will be ascertained via 16s-rRNA sequencing from stool.
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).
From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Secondary Outcomes (1)
Psychiatric Symptoms
From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Study Arms (2)
Treatment As Usual
ACTIVE COMPARATORPatients in the TAU group receive long-term rehabilitation drug treatment according to the 'community as a treatment'-model
6-weeks smoking cessation cognitive-behavioral therapy intervention
EXPERIMENTALThe "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).
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sigmund Freud PrivatUniversitatlead
- Medical University of Grazcollaborator
Study Sites (3)
Grüner Kreis Organization Johnsdorf Facility
Fehring, 8350, Austria
Medical University Graz
Graz, 8036, Austria
Sigmund Freud Private University Vienna
Vienna, 1020, Austria
Related Publications (2)
Fuchshuber J, Schober H, Wohlmuth M, Senra H, Rominger C, Schwerdtfeger A, Unterrainer HF. The effectiveness of a standardized tobacco cessation program on psychophysiological parameters in patients with addiction undergoing long-term rehabilitation: a quasi-experimental pilot study. BMC Med. 2024 May 1;22(1):184. doi: 10.1186/s12916-024-03405-z.
PMID: 38693570RESULTPeter J, Pritz A, Hiebler M, Mahmoudi M, Fuchshuber J, Morkl S, Holasek S, Humer E, Unterrainer HF. Metabolomic and gut microbial biomarkers of smoking cessation treatment in long-term drug therapy: a study protocol for a randomized controlled trial. Front Psychiatry. 2026 Mar 3;17:1677235. doi: 10.3389/fpsyt.2026.1677235. eCollection 2026.
PMID: 41853081DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2025
First Posted
January 31, 2025
Study Start
May 5, 2025
Primary Completion (Estimated)
October 28, 2026
Study Completion (Estimated)
October 28, 2026
Last Updated
March 25, 2026
Record last verified: 2026-03