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Clinical Trial 19630

Cancer Type: Healthy Subjects
Study Type: Prevention
NCT#: NCT03734666

Phase: N/A
Prinicipal Investigator: Christine Vinci

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or 1-800-679-0775 Learn More
Overview

Study Title

Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation

Summary

The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.

Objective

Aim 1: Modify an existing mindfulness-based treatment to include a focus on smoking cessation and reduced alcohol use. Study 1 will modify an existing substance use treatment,MBRP, to focus explicitly on smoking cessation and reducing alcohol use (MBRP-SA). Modification of the protocol will be conducted through an iterative development process based on the existing literature regarding mindfulness, smoking, and alcohol use, the expertise of the research team, and feedback from two small groups of participants (N=16). Aim 2: Evaluate benchmarks regarding the feasibility and acceptability of MBRP-SA. Study 2 will determine the ability of the research team to recruit and retain participants, to implement the designed protocol, and to determine treatment adherence. Participants (N=64) will be randomized to either MBRP-SA or CBT. Data on participants experience (e.g., acceptance,satisfaction, compliance) will be collected and examined. Aim 3: Collect and examine descriptive data on proximal and distal variables associated with increased smoking abstinence and reduced drinking. Proximal variables associated with smoking abstinence and reduced drinking (e.g., reduced negative affect, self-efficacy, craving), and the distal variables of smoking abstinence and heavy drinking will be collected and examined. We will also examine the feasibility for collecting data on potential moderators and/or mediators of treatment outcome. Aim 3 will be underpowered to test for any main effects of treatment on clinical outcomes. Nonetheless, these data will contribute to our understanding of the feasibility of collecting such data and allow us to observe any trends in particular directions.

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria Aim 1:

  • 18 years of age or older
  • Currently smoking 3 or more cigarettes per day for the past year.
  • Carbon monoxide level >/= 8 ppm(parts per million); should carbon monoxide level yield a result less than 8 ppm, participant will be asked to submit a urine sample to determine contine levels and the result must be >/ level 3
  • Participant must be motivated to quit smoking and decrease alcohol use within the next 60 days
  • If male, consume >/= 5 drinks and if female consume >/= 4 drinks on at least 1 occasion in the past month
  • Willing and able to attend the 8 weekly group sessions
  • Valid home address in the Tampa Bay area
  • Functioning telephone number
  • Can speak, read and write in English Inclusion Criteria Aim 2:
  • 18 years of age or older
  • Currently smoking 3 or more cigarettes per day for the past year.
  • Motivated to quit smoking and decrease alcohol use within the next 60 days
  • If male, consumes >/= 5 drinks and if female consumes >/= 4 drinks on at least 1 occasion in the past month
  • Willingness and ability to attend 8 weekly video group sessions
  • Willingness and ability to use an email account for study materials
  • Valid address
  • Functioning telephone number
  • Can speak, read and write in English

  • Exclusion Criteria

  • Cannot use nicotine patch
  • History of severe alcohol withdrawal symptoms (such as seizures, hallucinations, delirium)
  • Participants who have an active substance use disorder other than an alcohol use disorder
  • Participants who have an active psychotic disorder
  • Current use of tobacco cessation medications
  • Pregnant or nursing
  • Participants who have a household member already enrolled in the study

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.