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

Not Applicable
Completed
Conditions
Alcohol Use, Unspecified
Tobacco Use
Interventions
Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol
Behavioral: Cognitive Behavioral Therapy
Registration Number
NCT03734666
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
67
Inclusion Criteria

Not provided

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mindfulness Based Relapse PreventionMindfulness Based Relapse Prevention - Smoking and AlcoholParticipants 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).
Cognitive Behavioral TherapyCognitive Behavioral TherapyParticipants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills.
Primary Outcome Measures
NameTimeMethod
Aim 2: Participant RetentionEnd of study at Week 16 Follow-up

Percentage of participants retained through follow-up

Aim 2: Rate of Recruitment of Eligible Participants20 weeks

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

Aim 2: Number of Participants Scoring >3End 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%.

Aim 2: Percentage of Participants That Completed QuestionnairesEnd of study at Week 16 Follow-up

Percentage of participants who completed questionnaires at week 16

Secondary Outcome Measures
NameTimeMethod
Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-upAt 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.

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

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

Aim 3: Percent of Smoking Abstinence End of TreatmentEnd of Treatment at 8 Weeks

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

Trial Locations

Locations (1)

H Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

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