Clinical trial NCT06803706: Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: a Randomized Controlled Trial
Official title: Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use Disorder (SUD)
Alcohol Use Disorder (AUD)
Nicotine Addiction
Keywords: Metabolomics
Gut microbiome
Substance use disorder
nicotine addiction
smoking cessation
Lead sponsor: Sigmund Freud PrivatUniversitat
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2025-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria: Informed consent, a 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.

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Exclusion Criteria: lack of consent, age below 18, inability to provide informed consent, 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, or those consuming dietary supplements, probiotics, antibiotics, or prebiotic supplements during the study, prior participation in a smoking cessation programme.

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Primary outcomes:
measure: Self-efficacy
timeFrame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period
measure: General substance-related craving
timeFrame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
measure: Tobacco dependence
timeFrame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
measure: Primary Affects
timeFrame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
measure: Metabolome
timeFrame: From enrollment to the end of the 6-weeks treatment period.
measure: Gut microbiome
timeFrame: From enrollment to the end of the 6-weeks treatment period.
measure: Smoking behaviour
timeFrame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Secondary outcomes:
measure: Psychiatric Symptoms
timeFrame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
city: Johnsdorf Brunn
country: Austria
facility: Grüner Kreis Organization Johnsdorf Facility
city: Vienna
country: Austria
facility: Sigmund Freud Private University Vienna
Study officials:
References:
citation: 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.