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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.

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

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
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

Other trials in United States

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.

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 groups in NCT01982110
Study groupRoleWhat they receive
Mindfulness Based TherapyExperimentalCraving to Quit mobile application is provided for participants
Receives: Behavioral: Mindfulness based smoking cessation
Behavioral Smoking CessationActive comparatorNCI 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.

  1. Smoking behavior

    We will assess number of cigarettes smoked and CO levels

    Measured: 6 months

Secondary outcomes (1)
  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.

  1. First posted13 Nov 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2016
  4. Study completionOct 2018

Resources

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)
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

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.

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