Nicotine Use DisorderNCT06544057
Real-time eCounselling for Nicotine Addiction
A study testing CBT-MI in people with Nicotine Use Disorder, run by Overcome at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to pilot an eHealth intervention (real-time telecounselling) in nicotine addiction. The main questions it aims to answer are: Is the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Use Disorder
- What is being tested?
- CBT-MI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jul 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 Years old
- Self Reported smoking ≥ 5 cigarettes per day, or regular vaper of > 0mg nicotine
- Desire to quit nicotine consumption
- Willing to set a quit date
- Able to provide written informed consent to participate -
Who cannot join
- Enrolled in another behavioural intervention programme
- Pregnant, breastfeeding or planning to become pregnant.
- Individuals currently experiencing a problematic relationship with alcohol or drugs
- Documented Cognitive Impairment
- Individuals with a PHQ-9 score of ≥ 14 or a GAD-7 score of >12.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Key contact
Leicester, Midlands, LE67 2BF
Helen Hayward, BSc, 447423967654, operations_manager@overcome.org.uk
About this study
Official title: Real-time eCounselling for Nicotine Addiction: a Feasibility Study and Pilot RCT
The goal of this clinical trial is to pilot an eHealth intervention (real-time telecounselling) in nicotine addiction. The main questions it aims to answer are:
Is the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase in nicotine consumption? Is the intervention likely to be efficacious in influencing Readiness to quit nicotine? How feasible is the intervention for developing a larger-scale trial?
Researchers will compare a range of outcome measures between the active and control arms, to see if a pilot eHealth intervention can successfully treat nicotine addiction.
Read the detailed description
The goal of this clinical trial is to pilot an eHealth intervention in nicotine addiction (real-time telecounselling) . It will also attempt to better understand the psychology of nicotine addiction and craving regarding consumption behaviour. The main questions it aims to answer are:
Is the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase in nicotine consumption? Is the intervention likely to be efficacious in influencing Readiness to quit nicotine? How feasible is the intervention for developing a larger-scale trial?
Researchers will compare outcomes pre and post intervention in the active arm, and also between active and control arms, to ascertain the treatment effect of the intervention on primary (nicotine consumption, abstinence) and secondary (self-efficacy, readiness to quit, decisional balance) measures, in tests of efficacy.
Following randomisation, participants will be allocated to either the active arm or the control arm. In the active arm, participants will undergo six weekly sessions of real-time CBT-MI (Cognitive Behavioural Therapy with Motivational Interviewing), with each session lasting approximately 45 to 60 minutes. In the control arm: A Wait List Control Group (WLCG) will denote the comparator, who will undergo screening and assessment only.
- Conditions
- Nicotine Use Disorder
- Being tested
- CBT-MI
- Keywords
- Smoking cessation, Vaping, Public health, eHealth, Nicotine addiction, Feasibility
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-MIBehavioural
CBT-MI combines elements from Cognitive Behavioural Therapy and Motivational Interviewing in treating nicotine addiction, delivered remotely via Zoom by trained 'layperson coaches'
| Study group | Role | What they receive |
|---|---|---|
| CBT-MI | Experimental | Behavioural Therapy (CBT) with Motivational Interviewing (MI) techniques. It comprises six individual sessions delivered via real-time video (Zoom) on mobile or computer platforms. Sessions last approximately 45 to 60 minutes each. Receives: Behavioral: CBT-MI |
| Wait-list | No intervention | Control group will undergo recruitment and screening and be assigned to a wait-list, to undergo the intervention after the active group. Data collection will continue as in the active arm, to compare with that collected in the active arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence status
This is a binary indicator, suggesting whether or not participants are abstinent at point of questioning
Measured: 1 week post study: 7 days retrospective
Nicotine consumption (cigarettes, units)
Unit: Number of cigarettes consumed, on average, per day
Measured: Baseline; 6 weeks after the intervention
Nicotine consumption (cigarettes, time)
Time: Time spent smoking nicotine, on average, per day
Measured: Baseline; 6 weeks after the intervention
Nicotine consumption (vape, units)
Unit: Number of 15-minute 'episodes' of vaping, on average, per day
Measured: Baseline; 6 weeks after the intervention
Nicotine consumption (vape, time)
Time: Time spent vaping nicotine, on average, per day
Measured: Baseline; 6 weeks after the intervention
Secondary outcomes (5)
Dependence and Craving (CDS)
Cigarette dependence and craving experiences will be assessed using the Cigarette Dependence Scale (CDS), which measures various aspects of nicotine dependence, including withdrawal symptoms, desire to quit, time spent using, and the effects of consumption on activities. The scale has possible values of 1, 2, 3, 4, 5. On this ordinal scale, higher values denote stronger agreement.
Measured: Baseline; 6 weeks after the intervention
Dependence and Craving (EDS)
The (Electronic) e-Cigarette Dependence Scale (EDS) captures similar dimensions of dependence specific to e-cigarette use and will be administered at the same time points as the Cigarette Dependence Scale (CDS), which measures various aspects of nicotine dependence, including withdrawal symptoms, desire to quit, time spent using, and the effects of consumption on activities. This scale measures the level of nicotine dependence in those who use e-cigarettes or vapes. The scale has possible values of 1, 2, 3, 4, 5. On this ordinal scale, higher values denote stronger agreement.
Measured: Baseline; 6 weeks after the intervention
Readiness to Quit
Participants' readiness to quit smoking will be assessed using the contemplation ladder (CL), which measures their current stage of change in the quitting process. The Contemplation Ladder (CL) measures readiness to quit using an 11-point Likert scale, ranging from "No thoughts of quitting" (0) to "Taking action to quit" (10). he possible values of the measure were 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11. On this ordinal scale, higher values denote stronger agreement regarding readiness to quit.
Measured: Baseline; Every week during the intervention
Perceived Smoking Abstinence Efficacy as assessed by questionnaire measuring participants' confidence in their ability to quit smoking, and their resistance to temptation to relapse
The questionnaire comprises items related to positive social situations, negative affect situations, and habitual/craving situations. Responses will be recorded on a 5-point Likert scale ranging from 'Not at all tempted' to 'Extremely tempted'. The possible values of the measure were 1, 2, 3, 4, 5, 6, 7, 8, 9. On this ordinal scale, higher values denote stronger agreement regarding self-efficacy in nicotine abstinence.
Measured: Baseline; Every week during the intervention
Decisional balance
'Decisional balance' evaluates the pros and cons of nicotine consumption and quitting. This scale measures participant's relative weighing of the pros and cons of smoking/vaping. The possible values of the measure were 1, 2, 3, 4, 5. On this ordinal scale, higher values denote stronger agreement.
Measured: Baseline; Every week during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start8 Jul 2024
- Primary completion15 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nicotine Use DisorderStudies 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
- This was a two-arm Block randomised pilot trial with study centres using block randomisation comparing Wait-list and Active.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Overcome
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen Hayward, BSc, Study director, Overcome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544057
- Sponsor's protocol ID
- P-PF-03.24.0002
- Status last verified
- Nov 2024
- First submitted
- 12 Jul 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A member of the research team (HH) will regularly monitor the trial and its delivery to ensure ongoing study protocol compliance. In the event of deviations from the study protocol or unexpected events, the study team will promptly document and report such occurrences to the designated individuals and the Institutional Ethics review board, following the established reporting timelines. All study-related documentation, including data collection forms and interview transcripts, will be securely stored in password-protected electronic databases, adhering to data security and confidentiality guidelines.
Publications
Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. doi: 10.1037//0278-6133.10.5.360.
PubMed 1935872Etter JF, Le Houezec J, Perneger TV. A self-administered questionnaire to measure dependence on cigarettes: the cigarette dependence scale. Neuropsychopharmacology. 2003 Feb;28(2):359-70. doi: 10.1038/sj.npp.1300030.
PubMed 12589389Morean ME, Krishnan-Sarin S, Sussman S, Foulds J, Fishbein H, Grana R, O'Malley SS. Psychometric Evaluation of the E-cigarette Dependence Scale. Nicotine Tob Res. 2019 Oct 26;21(11):1556-1564. doi: 10.1093/ntr/ntx271.
PubMed 29301008Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.
PubMed 10170434Abrams, D. B., Herzog, T. A., Emmons, K. M., Linnan, L., & Stages of Change Working Group. (2000). Predicting smoking cessation from intentions and plans: Does type of smoker matter? Health Psychology, 19(1S), 24-33. DOI: 10.1016/j.addicn.2023.100068.
Fidancı, I., Sümer, H. C., & Fırat, S. (2017). The role of emotion regulation difficulties and smoking-related cognitions in understanding anxiety and smoking among treatment-seeking smokers. Journal of Cognitive Psychotherapy, 31(3), 227-240
Velicer WF, Diclemente CC, Rossi JS, Prochaska JO. Relapse situations and self-efficacy: an integrative model. Addict Behav. 1990;15(3):271-83. doi: 10.1016/0306-4603(90)90070-e.
PubMed 2378287
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time eCounselling for Nicotine Addiction: a Feasibility Study and Pilot RCT
- ClinicalTrials.gov ID
- NCT06544057
- Acronym / sponsor ID
- P-PF-03.24.0002
- Conditions
- Nicotine Use Disorder
- Keywords
- Smoking cessation, Vaping, Public health, eHealth, Nicotine addiction, Feasibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- OvercomeUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 9 Aug 2024 (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.
The goal of this clinical trial is to pilot an eHealth intervention (real-time telecounselling) in nicotine addiction. The main questions it aims to answer are:
Is the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase in nicotine consumption? Is the intervention likely to be efficacious in influencing Readiness to quit nicotine? How feasible is the intervention for developing a larger-scale trial?
Researchers will compare a range of outcome measures between the active and control arms, to see if a pilot eHealth intervention can successfully treat nicotine addiction.
Detailed description
The goal of this clinical trial is to pilot an eHealth intervention in nicotine addiction (real-time telecounselling) . It will also attempt to better understand the psychology of nicotine addiction and craving regarding consumption behaviour. The main questions it aims to answer are:
Is the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase in nicotine consumption? Is the intervention likely to be efficacious in influencing Readiness to quit nicotine? How feasible is the intervention for developing a larger-scale trial?
Researchers will compare outcomes pre and post intervention in the active arm, and also between active and control arms, to ascertain the treatment effect of the intervention on primary (nicotine consumption, abstinence) and secondary (self-efficacy, readiness to quit, decisional balance) measures, in tests of efficacy.
Following randomisation, participants will be allocated to either the active arm or the control arm. In the active arm, participants will undergo six weekly sessions of real-time CBT-MI (Cognitive Behavioural Therapy with Motivational Interviewing), with each session lasting approximately 45 to 60 minutes. In the control arm: A Wait List Control Group (WLCG) will denote the comparator, who will undergo screening and assessment only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This was a two-arm Block randomised pilot trial with study centres using block randomisation comparing Wait-list and Active.
| Arm | Type | Receives |
|---|---|---|
| CBT-MI | Experimental | Behavioral: CBT-MIBehavioural Therapy (CBT) with Motivational Interviewing (MI) techniques. It comprises six individual sessions delivered via real-time video (Zoom) on mobile or computer platforms. Sessions last approximately 45 to 60 minutes each. |
| Wait-list | No intervention | –Control group will undergo recruitment and screening and be assigned to a wait-list, to undergo the intervention after the active group. Data collection will continue as in the active arm, to compare with that collected in the active arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-65 Years old
- Self Reported smoking ≥ 5 cigarettes per day, or regular vaper of > 0mg nicotine
- Desire to quit nicotine consumption
- Willing to set a quit date
- Able to provide written informed consent to participate -
Key exclusion criteria (5 listed)
- Enrolled in another behavioural intervention programme
- Pregnant, breastfeeding or planning to become pregnant.
- Individuals currently experiencing a problematic relationship with alcohol or drugs
- Documented Cognitive Impairment
- Individuals with a PHQ-9 score of ≥ 14 or a GAD-7 score of >12.
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 |
|---|---|---|
| CBT-MICBT-MI combines elements from Cognitive Behavioural Therapy and Motivational Interviewing in treating nicotine addiction, delivered remotely via Zoom by trained 'layperson coaches' | Behavioural | CBT-MI |
Primary outcome
Abstinence status
Time frame: 1 week post study: 7 days retrospective
This is a binary indicator, suggesting whether or not participants are abstinent at point of questioning
Nicotine consumption (cigarettes, units)
Time frame: Baseline; 6 weeks after the intervention
Unit: Number of cigarettes consumed, on average, per day
Nicotine consumption (cigarettes, time)
Time frame: Baseline; 6 weeks after the intervention
Time: Time spent smoking nicotine, on average, per day
Nicotine consumption (vape, units)
Time frame: Baseline; 6 weeks after the intervention
Unit: Number of 15-minute 'episodes' of vaping, on average, per day
Nicotine consumption (vape, time)
Time frame: Baseline; 6 weeks after the intervention
Time: Time spent vaping nicotine, on average, per day
5 secondary outcomes
Dependence and Craving (CDS)
Time frame: Baseline; 6 weeks after the intervention
Dependence and Craving (EDS)
Time frame: Baseline; 6 weeks after the intervention
Readiness to Quit
Time frame: Baseline; Every week during the intervention
Perceived Smoking Abstinence Efficacy as assessed by questionnaire measuring participants' confidence in their ability to quit smoking, and their resistance to temptation to relapse
Time frame: Baseline; Every week during the intervention
Decisional balance
Time frame: Baseline; Every week during the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 1935872Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. doi: 10.1037//0278-6133.10.5.360.
- Background: PubMed 12589389Etter JF, Le Houezec J, Perneger TV. A self-administered questionnaire to measure dependence on cigarettes: the cigarette dependence scale. Neuropsychopharmacology. 2003 Feb;28(2):359-70. doi: 10.1038/sj.npp.1300030.
- Background: PubMed 29301008Morean ME, Krishnan-Sarin S, Sussman S, Foulds J, Fishbein H, Grana R, O'Malley SS. Psychometric Evaluation of the E-cigarette Dependence Scale. Nicotine Tob Res. 2019 Oct 26;21(11):1556-1564. doi: 10.1093/ntr/ntx271.
- Background: PubMed 10170434Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.
- BackgroundAbrams, D. B., Herzog, T. A., Emmons, K. M., Linnan, L., & Stages of Change Working Group. (2000). Predicting smoking cessation from intentions and plans: Does type of smoker matter? Health Psychology, 19(1S), 24-33. DOI: 10.1016/j.addicn.2023.100068.
- BackgroundFidancı, I., Sümer, H. C., & Fırat, S. (2017). The role of emotion regulation difficulties and smoking-related cognitions in understanding anxiety and smoking among treatment-seeking smokers. Journal of Cognitive Psychotherapy, 31(3), 227-240
- Background: PubMed 2378287Velicer WF, Diclemente CC, Rossi JS, Prochaska JO. Relapse situations and self-efficacy: an integrative model. Addict Behav. 1990;15(3):271-83. doi: 10.1016/0306-4603(90)90070-e.
- Individual participant dataSharing planned: No. A member of the research team (HH) will regularly monitor the trial and its delivery to ensure ongoing study protocol compliance. In the event of deviations from the study protocol or unexpected events, the study team will promptly document and report such occurrences to the designated individuals and the Institutional Ethics review board, following the established reporting timelines. All study-related documentation, including data collection forms and interview transcripts, will be securely stored in password-protected electronic databases, adhering to data security and confidentiality guidelines.
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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.
Helen Hayward, BSc study director
Overcome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-MI in people with Nicotine Use Disorder, run by Overcome at 1 site in United Kingdom.
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 5 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: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Hayward, BSc (447423967654, operations_manager@overcome.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence status (time frame: 1 week post study: 7 days retrospective). The study lists 5 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 NCT06544057, which also lists 7 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 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.