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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Alcohol Use, Unspecified; Tobacco Use

Treatments: Behavioral: Cognitive Behavioral Therapy; Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03734666

MCC-19630

R34AT009689 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Mindfulness Based Relapse Prevention

Experimental group

Description:

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).

Treatment:

Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol

Cognitive Behavioral Therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy