Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06544057

Real-time eCounselling for Nicotine Addiction

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Nicotine Use Disorder Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Smoking Cessation Substance-Related Disorders Tobacco Use Disorder Vaping

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Key contact

Leicester, Midlands, LE67 2BF, United Kingdom

Location status: Recruiting

Location contact

Helen Hayward, BSc

CONTACT

[email protected]

447423967654

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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.

Treatment and study plan

CBT-MI

Behavioral

CBT-MI combines elements from Cognitive Behavioural Therapy and Motivational Interviewing in treating nicotine addiction, delivered remotely via Zoom by trained 'layperson coaches'

Primary outcomes

  1. 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

  2. Nicotine consumption (cigarettes, units)

    Time frame: Baseline; 6 weeks after the intervention

    Unit: Number of cigarettes consumed, on average, per day

  3. Nicotine consumption (cigarettes, time)

    Time frame: Baseline; 6 weeks after the intervention

    Time: Time spent smoking nicotine, on average, per day

  4. Nicotine consumption (vape, units)

    Time frame: Baseline; 6 weeks after the intervention

    Unit: Number of 15-minute 'episodes' of vaping, on average, per day

  5. Nicotine consumption (vape, time)

    Time frame: Baseline; 6 weeks after the intervention

    Time: Time spent vaping nicotine, on average, per day

Secondary outcomes

  1. Dependence and Craving (CDS)

    Time frame: Baseline; 6 weeks after the intervention

    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.

  2. Dependence and Craving (EDS)

    Time frame: Baseline; 6 weeks after the intervention

    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.

  3. Readiness to Quit

    Time frame: Baseline; Every week during the intervention

    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.

  4. 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

    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.

  5. Decisional balance

    Time frame: Baseline; Every week during the intervention

    '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.

Study contacts

Contact information is provided by the study sponsor or research team.

Helen Hayward, BSc

CONTACT

[email protected]

447423967654

Sponsors and collaborators

Lead sponsor

Overcome

Other

Registry information

Official study title

Real-time eCounselling for Nicotine Addiction: a Feasibility Study and Pilot RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.