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

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734666
• Other study ID #: MCC-19630
• Secondary ID: R34AT009689
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: November 4, 2021

Study information

• Verified date: June 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified
• Tobacco Use

Intervention

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

Locations

Country	Name	City	State
United States	H Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aim 2: Number of Participants Scoring >3	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%.	End of Treatment at 8 Weeks
Primary	Aim 2: Rate of Recruitment of Eligible Participants	Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week	20 weeks
Primary	Aim 2: Participant Retention	Percentage of participants retained through follow-up	End of study at Week 16 Follow-up
Primary	Aim 2: Percentage of Participants That Completed Questionnaires	Percentage of participants who completed questionnaires at week 16	End of study at Week 16 Follow-up
Secondary	Aim 3: Percent of Smoking Abstinence End of Treatment	Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence.	End of Treatment at 8 Weeks
Secondary	Aim 3: Percent of Smoking Abstinence 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.	At 16 week follow-up
Secondary	Aim 3: Percent of Heavy Alcohol Use at End of Treatment	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.	End of Treatment at 8 Weeks
Secondary	Aim 3: Percentage of Heavy Alcohol Use 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.	At 16 week follow-up

External Links

•   Moffitt Cancer Center Clinical Trials Website