Nicotine DependenceMBSCNCT01982110
A Mindfulness Based Application for Smoking Cessation
A study testing Mindfulness based smoking cessation and Behavioral Smoking Cessation intervention in people with Nicotine Dependence, run by University of Virginia at 1 site in United States.
Trial summary
Cigarette smoking is the leading cause of preventable death and disability in the world. Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually. Additional effective, safe, and accessible treatments for nicotine dependence are needed due to the low abstinence rates (20-30%) achieved in… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Mindfulness based smoking cessation and Behavioral Smoking Cessation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2018
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who have given written informed consent
- 18 years of age or older
- Smoke an average of a minimum of five cigarettes per day
- Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of mindfulness techniques
- Express a wish to quit smoking
- A score at least in the "contemplation" range, as assessed via the Readiness to Change questionnaire (Heather \& McCambridge, 2013)
- Willingness to participate in mindfulness techniques
- Able to attend all clinic visits without interruption
Who cannot join
- Any current Axis I DSM-IV-TR psychiatric disorder other than alcohol abuse, marijuana abuse, or nicotine dependence that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality
- Serious medical comorbidity requiring medical intervention or close supervision, including seizures, pacemakers, heart transplant, severe arrhythmias, or active atrial fibrillation
- Suicide attempt in the last thirty days
- Gross neurological disease
- Mental retardation, which will be assessed by the PI, postdoctoral fellows, and doctoral students in clinical psychology
- Minors below the legal smoking age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Cigarette smoking is the leading cause of preventable death and disability in the world. Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually. Additional effective, safe, and accessible treatments for nicotine dependence are needed due to the low abstinence rates (20-30%) achieved in behavioral therapies, the unappealing side effects of pharmacotherapy, and the frequent lack of accessibility to treatment. Recent evidence supports the central role of craving in maintaining nicotine dependence, and neither behavioral nor replacement therapies directly target the relationship between cravings and smoking. Mindfulness therapy has been found to be effective in teaching strategies to decouple the association between craving and smoking. Mindfulness based smoking therapy (MT) has preliminary support for reducing consumption in smokers, and Dr. Judson Brewer has recently translated this program into a mobile device application (app) for smoking cessation. With Dr. Brewer's consultation, we propose to assess the feasibility of implementation of a MT mobile application in local hospital and community clinics and the effectiveness of the MT mobile application compared to a National Cancer Institute (NCI) QuitPal behavioral change group. We will examine smoking results at end of treatment and 2 and 6 month follow-up as well as the role of craving. If MT smoking cessation is determined to be effective in a mobile phone application, this finding will be a significant step in providing an additional effective and safe treatment for smokers wishing to quit or cut down on their intake, and will be especially important in providing treatment options for marginalized or hard-to-access individuals wishing to reduce cigarette intake.
Read the detailed description
Cigarette smoking is the leading cause of preventable death and disability in the world, accounting for 10% of all deaths. In the US, smoking costs more than $193 billion in health care costs and lost productivity per year. Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually. Mainstay behavioral treatments for smoking have focused on teaching individuals to avoid cues, foster positive affective states, develop lifestyle changes that reduce stress, divert attention from cravings, substitute other activities for smoking, learn cognitive strategies that reduce negative mood and develop social support mechanisms. These have shown modest success, with abstinence rates between only 20-30% over the past thirty years. This is presumably due to the complex nature of the acquisition and maintenance of nicotine addiction, including associative learning mechanisms as well as positive and negative reinforcement. Over time, cues that are judged to be positive or negative can induce affective states, which can then trigger a craving to smoke. Though the centrality of craving remains controversial, evidence suggests that craving is strongly associated with smoking, which, mainly through the physiological properties of nicotine, results in the maintenance or improvement of positive or reduction of negative affective states. This sets up reinforcement loops by reinforcing memories between affect and smoking. Thus, attention has been focused on additional strategies to help people tolerate negative affect and cravings rather than avoiding cues or substituting activities, and recent research suggest that MT may decouple the association between craving and smoking, thus facilitating smoking cessation.
Mindfulness training (MT) targets affective or craving states by teaching individuals to observe aversive body and mind states instead of reacting to them with habitual reactions, thus allowing more adaptive, healthier responses. Mindfulness training (MT) has shown promise in reducing anxiety and depression and has recently been explored in the treatment of addictions. In a 2011 randomized controlled trial by Brewer, et al., individuals who received an 8- session MT vs. the American Lung Association's 8 session freedom from smoking (FFS) treatment, showed significantly greater rate of reduction in cigarette use and greater point prevalence abstinence rates during treatment and maintained these gains during follow up. FFS is a behavior modification program and includes stress reduction and relapse prevention. Although both treatment groups were assigned home practice as part of their treatment, only those who received mindfulness training demonstrated a significant association between home practice and smoking outcomes, suggesting that there was a specific benefit to mindfulness practice and that positive treatment outcomes for those in this group are not merely a result of greater enthusiasm or interest in quitting. The ability of MT to attenuate the relationship between craving and substance use has been observed in other studies as well. Elwafi, et al. (2012) demonstrated that people who practiced mindfulness more smoked less, regardless of their level of craving. Practicing mindfulness appears critical to MT treatment outcomes. These results suggest that MT may help individuals develop a tolerance to craving itself, thus over time acting to dismantle the addictive loop. To date, research in this area has been conducted in randomized clinical trials in structured laboratory settings only. Important next steps are to examine the effectiveness of MT treatments for smoking cessation in naturalistic environments and to utilize methods of delivering treatment in real world settings that will facilitate compliance with mindfulness practice and thus improve treatment outcomes - for example, via a mobile device application. Additionally, trials comparing MT to alternative treatment approaches typically offered in outpatient clinics such as support groups, acupuncture, individual counseling, or nicotine replacement therapies are lacking. Mindfulness based (MT) smoking cessation has been adapted to a mobile device application called "Craving to Quit" based on the work done by Brewer and will be the mindfulness intervention used in this study. Standardization and implementation via a mobile application is a logical and necessary next step in the dissemination of treatment and will potentially provide access to an effective smoking cessation program for persons who may not otherwise be able to access treatment.
- Conditions
- Nicotine Dependence
- Being tested
- Mindfulness based smoking cessation, Behavioral Smoking Cessation intervention
- Keywords
- smoking cessation, mindfulness, behavioral intervention
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based smoking cessationBehavioural
Also called Craving to Quit
Mindfulness based interventions are provided via a mobile phone application.
Behavioral Smoking Cessation interventionBehavioural
Also called Behavioral therapy, Cognitive Behavioral therapy, NCI QuitPal
Behavioral Smoking Cessation intervention is a behaviorally based intervention is provided via a mobile phone application.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Therapy | Experimental | Craving to Quit mobile application is provided for participants Receives: Behavioral: Mindfulness based smoking cessation |
| Behavioral Smoking Cessation | Active comparator | NCI Quit Pal via a mobile phone application is provided for participants Receives: Behavioral: Behavioral Smoking Cessation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking behavior
We will assess number of cigarettes smoked and CO levels
Measured: 6 months
Secondary outcomes (1)
Craving
We will assess levels of craving to smoke.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2016
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Kim Penberthy, University of Virginia
- Investigators
- Jennifer K Penberthy, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982110
- Sponsor's protocol ID
- 17004
- Acronym
- MBSC
- Status last verified
- Apr 2019
- First submitted
- 29 Oct 2013
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
PubMed 35420700
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness Based Application for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01982110
- Acronym / sponsor ID
- MBSC / 17004
- Conditions
- Nicotine Dependence
- Keywords
- smoking cessation, mindfulness, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 13 Nov 2013 (estimated)
- 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.
Cigarette smoking is the leading cause of preventable death and disability in the world. Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually. Additional effective, safe, and accessible treatments for nicotine dependence are needed due to the low abstinence rates (20-30%) achieved in behavioral therapies, the unappealing side effects of pharmacotherapy, and the frequent lack of accessibility to treatment. Recent evidence supports the central role of craving in maintaining nicotine dependence, and neither behavioral nor replacement therapies directly target the relationship between cravings and smoking. Mindfulness therapy has been found to be effective in teaching strategies to decouple the association between craving and smoking. Mindfulness based smoking therapy (MT) has preliminary support for reducing consumption in smokers, and Dr. Judson Brewer has recently translated this program into a mobile device application (app) for smoking cessation. With Dr. Brewer's consultation, we propose to assess the feasibility of implementation of a MT mobile application in local hospital and community clinics and the effectiveness of the MT mobile application compared to a National Cancer Institute (NCI) QuitPal behavioral change group. We will examine smoking results at end of treatment and 2 and 6 month follow-up as well as the role of craving. If MT smoking cessation is determined to be effective in a mobile phone application, this finding will be a significant step in providing an additional effective and safe treatment for smokers wishing to quit or cut down on their intake, and will be especially important in providing treatment options for marginalized or hard-to-access individuals wishing to reduce cigarette intake.
Detailed description
Cigarette smoking is the leading cause of preventable death and disability in the world, accounting for 10% of all deaths. In the US, smoking costs more than $193 billion in health care costs and lost productivity per year. Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually. Mainstay behavioral treatments for smoking have focused on teaching individuals to avoid cues, foster positive affective states, develop lifestyle changes that reduce stress, divert attention from cravings, substitute other activities for smoking, learn cognitive strategies that reduce negative mood and develop social support mechanisms. These have shown modest success, with abstinence rates between only 20-30% over the past thirty years. This is presumably due to the complex nature of the acquisition and maintenance of nicotine addiction, including associative learning mechanisms as well as positive and negative reinforcement. Over time, cues that are judged to be positive or negative can induce affective states, which can then trigger a craving to smoke. Though the centrality of craving remains controversial, evidence suggests that craving is strongly associated with smoking, which, mainly through the physiological properties of nicotine, results in the maintenance or improvement of positive or reduction of negative affective states. This sets up reinforcement loops by reinforcing memories between affect and smoking. Thus, attention has been focused on additional strategies to help people tolerate negative affect and cravings rather than avoiding cues or substituting activities, and recent research suggest that MT may decouple the association between craving and smoking, thus facilitating smoking cessation.
Mindfulness training (MT) targets affective or craving states by teaching individuals to observe aversive body and mind states instead of reacting to them with habitual reactions, thus allowing more adaptive, healthier responses. Mindfulness training (MT) has shown promise in reducing anxiety and depression and has recently been explored in the treatment of addictions. In a 2011 randomized controlled trial by Brewer, et al., individuals who received an 8- session MT vs. the American Lung Association's 8 session freedom from smoking (FFS) treatment, showed significantly greater rate of reduction in cigarette use and greater point prevalence abstinence rates during treatment and maintained these gains during follow up. FFS is a behavior modification program and includes stress reduction and relapse prevention. Although both treatment groups were assigned home practice as part of their treatment, only those who received mindfulness training demonstrated a significant association between home practice and smoking outcomes, suggesting that there was a specific benefit to mindfulness practice and that positive treatment outcomes for those in this group are not merely a result of greater enthusiasm or interest in quitting. The ability of MT to attenuate the relationship between craving and substance use has been observed in other studies as well. Elwafi, et al. (2012) demonstrated that people who practiced mindfulness more smoked less, regardless of their level of craving. Practicing mindfulness appears critical to MT treatment outcomes. These results suggest that MT may help individuals develop a tolerance to craving itself, thus over time acting to dismantle the addictive loop. To date, research in this area has been conducted in randomized clinical trials in structured laboratory settings only. Important next steps are to examine the effectiveness of MT treatments for smoking cessation in naturalistic environments and to utilize methods of delivering treatment in real world settings that will facilitate compliance with mindfulness practice and thus improve treatment outcomes - for example, via a mobile device application. Additionally, trials comparing MT to alternative treatment approaches typically offered in outpatient clinics such as support groups, acupuncture, individual counseling, or nicotine replacement therapies are lacking. Mindfulness based (MT) smoking cessation has been adapted to a mobile device application called "Craving to Quit" based on the work done by Brewer and will be the mindfulness intervention used in this study. Standardization and implementation via a mobile application is a logical and necessary next step in the dissemination of treatment and will potentially provide access to an effective smoking cessation program for persons who may not otherwise be able to access treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Therapy | Experimental | Behavioral: Mindfulness based smoking cessationCraving to Quit mobile application is provided for participants |
| Behavioral Smoking Cessation | Active comparator | Behavioral: Behavioral Smoking Cessation interventionNCI Quit Pal via a mobile phone application is provided for participants |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females who have given written informed consent
- 18 years of age or older
- Smoke an average of a minimum of five cigarettes per day
- Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of mindfulness techniques
- Express a wish to quit smoking
Key exclusion criteria (6 listed)
- Any current Axis I DSM-IV-TR psychiatric disorder other than alcohol abuse, marijuana abuse, or nicotine dependence that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality
- Serious medical comorbidity requiring medical intervention or close supervision, including seizures, pacemakers, heart transplant, severe arrhythmias, or active atrial fibrillation
- Suicide attempt in the last thirty days
- Gross neurological disease
- Mental retardation, which will be assessed by the PI, postdoctoral fellows, and doctoral students in clinical psychology
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 |
|---|---|---|
| Mindfulness based smoking cessationAlso: Craving to QuitMindfulness based interventions are provided via a mobile phone application. | Behavioural | Mindfulness Based Therapy |
| Behavioral Smoking Cessation interventionAlso: Behavioral therapy, Cognitive Behavioral therapy, NCI QuitPalBehavioral Smoking Cessation intervention is a behaviorally based intervention is provided via a mobile phone application. | Behavioural | Behavioral Smoking Cessation |
Primary outcome
Smoking behavior
Time frame: 6 months
We will assess number of cigarettes smoked and CO levels
1 secondary outcome
Craving
Time frame: 6 months
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 17 Apr 2019.
- Derived from this study: PubMed 35420700Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
- 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.
Jennifer K Penberthy, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based smoking cessation and Behavioral Smoking Cessation intervention in people with Nicotine Dependence, run by University of Virginia at 1 site in United States.
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 6 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 17 Apr 2019. 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 States. 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?
Smoking behavior (time frame: 6 months). 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 NCT01982110, which also lists 1 linked publication.
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 17 Apr 2019.