Clinical trial NCT03734666: Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Official title: Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Alcohol Use, Unspecified
Keywords: alcohol drinking
quit smoking
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-11-08
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Aim 2: Number of Participants Scoring >3
timeFrame: End of Treatment at 8 Weeks
measure: Aim 2: Rate of Recruitment of Eligible Participants
timeFrame: 20 weeks
measure: Aim 2: Participant Retention
timeFrame: End of study at Week 16 Follow-up
measure: Aim 2: Percentage of Participants That Completed Questionnaires
timeFrame: End of study at Week 16 Follow-up
Secondary outcomes:
measure: Aim 3: Percent of Smoking Abstinence End of Treatment
timeFrame: End of Treatment at 8 Weeks
measure: Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up
timeFrame: At 16 week follow-up
measure: Aim 3: Percent of Heavy Alcohol Use at End of Treatment
timeFrame: End of Treatment at 8 Weeks
measure: Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up
timeFrame: At 16 week follow-up
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Christine Vinci, PhD
role: PRINCIPAL_INVESTIGATOR
References: