Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation (NCT03734666) | Clinical Trial Compass
CompletedNot Applicable
Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
United States67 participantsStarted 2019-01-14
Plain-language summary
The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 med…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Aim 2: Number of Participants Scoring >3
Timeframe: End of Treatment at 8 Weeks
2
Aim 2: Rate of Recruitment of Eligible Participants
Timeframe: 20 weeks
3
Aim 2: Participant Retention
Timeframe: End of study at Week 16 Follow-up
4
Aim 2: Percentage of Participants That Completed Questionnaires
Timeframe: End of study at Week 16 Follow-up
Trial details
NCT IDNCT03734666
SponsorH. Lee Moffitt Cancer Center and Research Institute