N/A
Completed N=67
Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Tobacco Use · Alcohol Use, Unspecified
Source: ClinicalTrials.gov NCT03734666 ↗
Enrolled (actual)
67
Serious AEs
6.0%
Results posted
Jun 2023
Primary outcomePrimary: Aim 2: Number of Participants Scoring >3 — 18; 16 participants
Summary
The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aim 2: Number of Participants Scoring >3 |
18; 16 | — |
| PRIMARY Aim 2: Rate of Recruitment of Eligible Participants |
6 | — |
| PRIMARY Aim 2: Participant Retention |
46; 50 | — |
| PRIMARY Aim 2: Percentage of Participants That Completed Questionnaires |
34.7; 31.4 | — |
| SECONDARY Aim 3: Percent of Smoking Abstinence End of Treatment |
34.3; 31.3 | — |
| SECONDARY Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up |
14.3; 3.1 | — |
| SECONDARY Aim 3: Percent of Heavy Alcohol Use at End of Treatment |
4; 6.3 | — |
| SECONDARY Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up |
5.1; 4.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT03734666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.