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NCT Number: NCT07447635

Testing an MBI for Smoking Cessation and Alcohol Use Among Cancer Survivors

This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.

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Key information

Conditions

Smoking Cessation Alcohol Drinking Alcohol Use Behavior Drinking Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Christine Vinci, PhD

PRINCIPAL_INVESTIGATOR

Katie Witkiewitz, PhD

SUB_INVESTIGATOR

Kea Turner, PhD

SUB_INVESTIGATOR

Margaret Byrne, PhD

SUB_INVESTIGATOR

Steve Sutton, PhD

SUB_INVESTIGATOR

Vani Simmons, PhD

SUB_INVESTIGATOR

About this study

The primary aim of this study is to test the efficacy of MBRP-SA compared with standard care among cancer survivors, explore potential moderators, mechanisms, and predictors of treatment effects, and evaluate implementation outcomes to guide future adoption of MBRP-SA.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ≥18 years old
  • History of a cancer diagnosis at any point in lifetime
  • Smoked ≥1 cigarette/day in past month
  • At least one binge drinking episode in past month or exceeds weekly drinking limits
  • Motivated to quit smoking and modify alcohol use in next 30 days
  • Valid home address in Florida
  • English-speaking, reading, and writing ability

Exclusion criteria

  • Pregnancy or lactation
  • Active psychotic disorder
  • History of severe alcohol withdrawal
  • Current use of tobacco cessation medication or other treatments to quit smoking
  • End-of-life or hospice care
  • Household member already enrolled

Treatment and study plan

Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)

Behavioral

MBRP-SA is a nine-week, group-based mindfulness program designed to help cancer survivors quit smoking and reduce heavy alcohol use by targeting craving, stress, and habitual behavior patterns. Participants will also receive 10 weeks of nicotine replacement therapy.

Quitline Support

Behavioral

Participants will be connected to the Florida Tobacco Quitline, which provides standard evidence-based smoking cessation support, including phone-based counseling, web-based resources, and access to text-messaging programs. The Quitline also offers up to a four-week supply of nicotine replacement therapy (patches, gum, or lozenges). Participants will also receive referrals to various alcohol-related treatment options in the community.

Primary outcomes

  1. Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence

    Time frame: 6 months post treatment

    Self-reported no combustible tobacco use in the past 7 days, verified with saliva cotinine <10 ng/mL.

  2. Percent Heavy Drinking Days (Past 4 Weeks)

    Time frame: 6 months post treatment

    Percentage of days in the past 4 weeks meeting heavy drinking criteria (≥5 drinks for men; ≥4 drinks for women)

Study contacts

Contact information is provided by the study sponsor or research team.

Marilyn Horta, PhD

CONTACT

[email protected]

813-745-3861

Skye Dougan, MPH

CONTACT

[email protected]

813-745-4376

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Florida Biomedical Research Program - James & Esther King

Registry information

Official study title

Smoking Cessation and Alcohol Use Among Cancer Survivors: Investigating the Efficacy of a Mindfulness-Based Intervention

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 3, 2026
Registry last updated
May 18, 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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