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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03734666
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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

Condition or disease Intervention/treatment Phase
Tobacco Use Alcohol Use, Unspecified Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol Behavioral: Cognitive Behavioral Therapy Not Applicable

Detailed Description:

This study evaluates a mindfulness-based treatment to concurrently target cigarette smoking and alcohol use behaviors in adults.

Aim 1: Modify an existing mindfulness-based treatment to include a focus on smoking cessation and reduced alcohol use.

Aim 2: Evaluate benchmarks regarding the feasibility and acceptability of Mindfulness Based Relapse Prevention -Smoking and Alcohol Use.

Aim 3: Collect and examine descriptive data on proximal and distal variables associated with increased smoking abstinence and reduced drinking.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness Based Relapse Prevention
Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA).
Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol
Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.
Other Name: MBRP

Active Comparator: Cognitive Behavioral Therapy
Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.
Behavioral: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.
Other Name: CBT




Primary Outcome Measures :
  1. Aim 2: Participant Satisfaction [ Time Frame: End of treatment (Week 21) ]
    Patient satisfaction will be determined through a score on the Client Satisfaction Questionnaire Version 8 (Attkinson & Greenfield), where participants respond to 8 items on a 4-point scale (1=very dissatisfied; 4=very satisfied).

  2. Aim 2: Rate of Recruitment [ Time Frame: End of recruitment, Year 3 ]
    Rate of recruitment per month

  3. Aim 2: Participant Retention [ Time Frame: End of study, Year 3 ]
    Number of participants retained through follow-up

  4. Aim 2: Questionnaire Completion [ Time Frame: End of study, Year 3 ]
    Percentage of questionnaires completed


Secondary Outcome Measures :
  1. Aim 3: Rate of Smoking Abstinence [ Time Frame: End of treatment, 16 week follow-up ]
    Rate of smoking abstinence, measured by carbon monoxide (CO) verification and self-report of no smoking in the past 7 days. CO readings of less than 8 ppm provides biochemical verification of smoking abstinence.

  2. Aim 3: Rate of Alcohol Use [ Time Frame: End of treatment, 16 week follow-up ]
    Rate of Alcohol use, measured by self-report of no alcohol consumption in the past 7 days at end of study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 >/= drinks on at least 5 occasions 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

Exclusion Criteria:

  • Unable to wear nicotine patch
  • Participants who have an active substance use disorder other than an alcohol use disorder
  • Participants who have an active psychotic disorder
  • Regular use of other tobacco products such as cigars, e-cigarettes
  • Current use of tobacco cessation medications
  • Pregnant or nursing
  • Participants who have a household member already enrolled in the study.
  • In rare cases, study staff might exclude a participant for a reason not specified here

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734666


Locations
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United States, Florida
H Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Laura Hernandez    813-745-8280    Laura.Hernandez@moffitt.org   
Principal Investigator: Christine Vinci, PhD         
Sub-Investigator: Thomas Brandon, PhD         
Sub-Investigator: David Drobes, PhD         
Sub-Investigator: Steve Sutton, PhD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Christine Vinci, PhD H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03734666     History of Changes
Other Study ID Numbers: MCC-19630
R34AT009689 ( U.S. NIH Grant/Contract )
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
alcohol drinking
quit smoking
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs