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Completed

NCT Number: NCT03734666

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

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

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Key information

Conditions

Tobacco Use Alcohol Drinking Alcohol Use, Unspecified Behavior Drinking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • 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

Treatment and study plan

Mindfulness Based Relapse Prevention - Smoking and Alcohol

Behavioral

Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.

Other names: MBRP

Cognitive behavioral therapy

Behavioral

Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.

Other names: CBT

Primary outcomes

  1. Aim 2: Number of Participants Scoring >3

    Time frame: End of Treatment at 8 Weeks

    Number of participants scoring >3. 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). Results reported indicate clients with a patient satisfaction score over 80%.

  2. Aim 2: Rate of Recruitment of Eligible Participants

    Time frame: 20 weeks

    Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week

  3. Aim 2: Participant Retention

    Time frame: End of study at Week 16 Follow-up

    Percentage of participants retained through follow-up

  4. Aim 2: Percentage of Participants That Completed Questionnaires

    Time frame: End of study at Week 16 Follow-up

    Percentage of participants who completed questionnaires at week 16

Secondary outcomes

  1. Aim 3: Percent of Smoking Abstinence End of Treatment

    Time frame: End of Treatment at 8 Weeks

    Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence.

  2. Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up

    Time frame: At 16 week follow-up

    Percent of smoking abstinence, measured by biochemical verification of abstinence via saliva continine and self-report of no smoking in the past 7 days. Participants who report abstinence will be mailed a saliva continine kit to confirm abstinence at their 16 week follow up call.

  3. Aim 3: Percent of Heavy Alcohol Use at End of Treatment

    Time frame: End of Treatment at 8 Weeks

    Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men.

  4. Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up

    Time frame: At 16 week follow-up

    Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 8, 2018
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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