Substance Use Disorder (SUD)NCT06803706

Metabolome and Gut Microbiome Changes During Smoking Cessation in Long-term Drug Therapy in a Therapeutic Community

A study testing 6-weeks CBT smoking cessation programme and Long-term drug therapy within a therapeutic community in people with Substance Use Disorder (SUD) and Alcohol Use Disorder (AUD), run by Sigmund Freud PrivatUniversitat at 3 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Substance Use Disorder (SUD), Alcohol Use Disorder (AUD), Nicotine Addiction
What is being tested?: 6-weeks CBT smoking cessation programme and Long-term drug therapy within a therapeutic community
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 97 participants
Where: 3 sitesAustria
Study dates: 5 May 2025to 18 Sep 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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 join

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)

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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

Trial locations and contacts

3 sites in 1 country.

Austria3 sites

Grüner Kreis Organization Johnsdorf Facility
Fehring, 8350
Medical University Graz
Graz, 8036
Sigmund Freud Private University Vienna
Vienna, 1020

Other trials in Austria

About this study

Official title: Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: A Randomized Controlled Trial

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.

Conditions: Substance Use Disorder (SUD), Alcohol Use Disorder (AUD), Nicotine Addiction, Healthy Adult Participants
Being tested: 6-weeks CBT smoking cessation programme, Long-term drug therapy within a therapeutic community
Keywords: Metabolomics, Gut microbiome, Substance use disorder, nicotine addiction, smoking cessation
Medical subject headings: Substance-Related Disorders, Alcoholism, Tobacco Use Disorder, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

6-weeks CBT smoking cessation programmeBehavioural
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.
Long-term drug therapy within a therapeutic communityBehavioural
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.

Study groups in NCT06803706
Study group	Role	What they receive
Treatment As Usual	Active comparator	Patients in the TAU group receive long-term rehabilitation drug treatment according to the 'community as a treatment'-model Receives: Behavioral: Long-term drug therapy within a therapeutic community
6-weeks smoking cessation cognitive-behavioral therapy intervention	Experimental	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). Receives: Behavioral: 6-weeks CBT smoking cessation programme; Behavioral: Long-term drug therapy within a therapeutic community
Healthy controls	No intervention	Control group with n=50 healthy adult subjects, examined at a single timepoint. No interventions will be administered in this arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From enrollment to the end of the 6-weeks treatment period.
Gut microbiome
Gut microbiome will be ascertained via 16s-rRNA sequencing from stool.
Measured: 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).
Measured: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.

Secondary outcomes (1)

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.
Measured: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 202518 Sep 2026

First posted31 Jan 2025
Study start5 May 2025
Primary completion18 Sep 2026
Study completion18 Sep 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Additional to the randomized controlled design, a third, cross-sectional, non-interventional healthy control group (n=50) will be examined additionally at a single timepoint.
Masking: None (open label)
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06803706
Sponsor's protocol ID: 1155/2024
Other IDs: 1155/2024
Status last verified: Mar 2026
First submitted: 23 Jan 2025
Last updated: 29 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 38693570
Peter 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.
PubMed 41853081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Metabolomic and Gut Microbial Biomarkers of Smoking Cessation Treatment in Long-term Drug Therapy: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06803706
Acronym / sponsor ID: 1155/2024
Conditions: Substance Use Disorder (SUD), Alcohol Use Disorder (AUD), Nicotine Addiction, Healthy Adult Participants
Keywords: Metabolomics, Gut microbiome, Substance use disorder, nicotine addiction, smoking cessation
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Sigmund Freud PrivatUniversitatUniversity, hospital or other
Collaborators: Medical University of Graz
Study start: 5 May 2025 (actual)
Primary completion: 18 Sep 2026 (actual)
Study completion: 18 Sep 2026 (actual)
First posted: 31 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Additional to the randomized controlled design, a third, cross-sectional, non-interventional healthy control group (n=50) will be examined additionally at a single timepoint.

Arm	Type	Receives
Treatment As Usual	Active comparator	Behavioral: Long-term drug therapy within a therapeutic communityPatients 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	Experimental	Behavioral: 6-weeks CBT smoking cessation programme, Behavioral: Long-term drug therapy within a therapeutic communityThe "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).
Healthy controls	No intervention	–Control group with n=50 healthy adult subjects, examined at a single timepoint. No interventions will be administered in this arm.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (9 listed)

lack of consent, inability to provide informed consent
age below 18,
acute psychotic symptoms or acute suicidal tendencies
cardiovascular disease
pregnancy or breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
6-weeks CBT smoking cessation programmeHeld 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.	Behavioural	6-weeks smoking cessation cognitive-behavioral therapy intervention
Long-term drug therapy within a therapeutic communityThe 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.	Behavioural	6-weeks smoking cessation cognitive-behavioral therapy intervention, Treatment As Usual

Primary outcome

Self-efficacy
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period
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.
General substance-related craving
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
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.
Tobacco dependence
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
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.
Primary Affects
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
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.
Metabolome
Time frame: From enrollment to the end of the 6-weeks treatment period.
Metabolome will be ascertained from blood via state-of-the-art NMR (nuclear magnetic resonance).
Gut microbiome
Time frame: From enrollment to the end of the 6-weeks treatment period.
Gut microbiome will be ascertained via 16s-rRNA sequencing from stool.
Smoking behaviour
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.
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).

1 secondary outcome

Psychiatric Symptoms
Time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Results publication: PubMed 38693570Fuchshuber 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.
Derived from this study: PubMed 41853081Peter 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-efficacy (time frame: From enrollment to follow-up 3 months after the end of the 6-weeks treatment period). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06803706, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.