CravingSOPHCIGNCT04700306
Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal
A study testing Sophrology in people with Craving and Cigarette Smoking, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
Trial summary
To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Craving, Cigarette Smoking
- What is being tested?
- Sophrology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Jun 2021to 9 Sep 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First outpatient consultation in tobacco addiction department
- Consumption greater than or equal to 35 cigarettes per week
- Minimum age: 18 years old / Maximum age: 75 years old
- Absence of co-addiction of alcohol, other products and behavioural addictions (except if withdrawal for more than 1 year)
- Commitment by the patient not to practice hypnosis or mindfulness while participating in the study
- Mastering reading and writing skills
- Acceptance to participate in the protocol
- Affiliated to a social security system
Who cannot join
- Patient-reported psychosis
- Pregnant women
- Participation in other intervention research
- Patient under guardianship or curatorship
- Refusal to participate in the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHI Créteil Equipe de liaison et de soins en addictologie (ELSA)
Créteil, 94000
CHU Henri Mondor Service d'addictologie
Créteil, 94000
About this study
To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal.
Read the detailed description
Pilot study to evaluate the impact of sophrology on the intensity of craving and on certain determinants of cigarette consumption: number of cigarettes, anxiety, degree of dependence, motivation, confidence, fatigue, irritability, quality of sleep.
This pilot study could serve as a basis for the development of research on a larger cohort.
- Conditions
- Craving, Cigarette Smoking
- Being tested
- Sophrology
- Keywords
- Sophrology
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SophrologyBehavioural
Patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology.
| Study group | Role | What they receive |
|---|---|---|
| Sophrology | Experimental | the patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology Receives: Behavioral: Sophrology |
| Control | No intervention | the patient must make 7 visits with interviews and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84)
Comparison of the inte craving between the sophrology group and the control group at nsity of 6 months after the end of consultations, using the FTCQ-12 questionnaire.
Measured: 6 months after the end of consultations
Secondary outcomes (8)
Number of cigarettes smoked per day
Number of cigarettes smoked per day
Measured: 6 months after the end of consultations
Motivation to Quit Smoking by Numerical Scale (0 to 5)
Assessment of Motivation to Quit Smoking
Measured: 6 months after the end of consultations
Measuring Confidence in Withdrawal Success by numerical scale (0 to 5)
Measuring Confidence in Withdrawal Success
Measured: 6 months after the end of consultations
Evaluation of sleep by numerical scale (0 to 5)
Evaluation of sleep quality
Measured: 6 months after the end of consultations
Evaluation of irritability by numerical scale (0 to 5)
Evaluation of irritability levels
Measured: 6 months after the end of consultations
Fatigue levels by numerical scale (0 to 5)
Evaluation of fatigue levels
Measured: 6 months after the end of consultations
Fagerström test (0 to 11)
Comparison of dependency
Measured: 6 months after the end of consultations
CO (carbon monoxide) test
Comparison of the evolution of the CO
Measured: 6 months after the end of consultations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start23 Jun 2021
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CravingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie Ané, Principal investigator, Centre Hospitalier Intercommunal Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700306
- Sponsor's protocol ID
- SOPHCIG
- Acronym
- SOPHCIG
- Status last verified
- Jun 2025
- First submitted
- 27 Nov 2020
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Added Value of Sophrology on the Intensity of Craving During Smoking Withdrawal
- ClinicalTrials.gov ID
- NCT04700306
- Acronym / sponsor ID
- SOPHCIG / SOPHCIG
- Conditions
- Craving, Cigarette Smoking
- Keywords
- Sophrology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 7 Jan 2021 (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.
To evaluate the added value of Sophrology on the intensity of craving during cigarette withdrawal.
Detailed description
Pilot study to evaluate the impact of sophrology on the intensity of craving and on certain determinants of cigarette consumption: number of cigarettes, anxiety, degree of dependence, motivation, confidence, fatigue, irritability, quality of sleep.
This pilot study could serve as a basis for the development of research on a larger cohort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sophrology | Experimental | Behavioral: Sophrologythe patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology |
| Control | No intervention | –the patient must make 7 visits with interviews and questionnaires |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- First outpatient consultation in tobacco addiction department
- Consumption greater than or equal to 35 cigarettes per week
- Minimum age: 18 years old / Maximum age: 75 years old
- Absence of co-addiction of alcohol, other products and behavioural addictions (except if withdrawal for more than 1 year)
- Commitment by the patient not to practice hypnosis or mindfulness while participating in the study
Key exclusion criteria (5 listed)
- Patient-reported psychosis
- Pregnant women
- Participation in other intervention research
- Patient under guardianship or curatorship
- Refusal to participate in the study
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 |
|---|---|---|
| SophrologyPatient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology. | Behavioural | Sophrology |
Primary outcome
FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84)
Time frame: 6 months after the end of consultations
Comparison of the inte craving between the sophrology group and the control group at nsity of 6 months after the end of consultations, using the FTCQ-12 questionnaire.
8 secondary outcomes
Number of cigarettes smoked per day
Time frame: 6 months after the end of consultations
Motivation to Quit Smoking by Numerical Scale (0 to 5)
Time frame: 6 months after the end of consultations
Measuring Confidence in Withdrawal Success by numerical scale (0 to 5)
Time frame: 6 months after the end of consultations
Evaluation of sleep by numerical scale (0 to 5)
Time frame: 6 months after the end of consultations
Evaluation of irritability by numerical scale (0 to 5)
Time frame: 6 months after the end of consultations
Fatigue levels by numerical scale (0 to 5)
Time frame: 6 months after the end of consultations
Fagerström test (0 to 11)
Time frame: 6 months after the end of consultations
CO (carbon monoxide) test
Time frame: 6 months after the end of consultations
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Sylvie Ané principal investigator
Centre Hospitalier Intercommunal Créteil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sophrology in people with Craving and Cigarette Smoking, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
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 5 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: stopped early, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was stopped early (reason given: lack of inclusion). Results are not available in the source record.
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?
FTCQ-12 questionnaire (French Tobacco Craving Questionnaire - 12 items) (0 to 84) (time frame: 6 months after the end of consultations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.