Nicotine Dependence Clinical Trial
— MBSCOfficial title:
A Mindfulness Based Application for Smoking Cessation
NCT number | NCT01982110 |
Other study ID # | 17004 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | October 2018 |
Verified date | April 2019 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | October 2018 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking behavior | We will assess number of cigarettes smoked and CO levels | 6 months | |
Secondary | Craving | We will assess levels of craving to smoke. | 6 months |
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