Alcohol Drinking, Smoking Cessation
Conditions
Brief summary
The overall objective of this project is to develop and pilot-test a web-based smoking cessation program that specifically addresses heavy drinking (HD). The project builds upon a well-established, free evidence-based smoking cessation website, BecomeAnEX.org (EX), which is supported by Truth Initiative, a national non-profit public health organization, and its research arm, the Schroeder Institute. Investigators will develop an alternative version of BecomenAnEX that will include detailed content on alcohol's relation to smoking relapse, health effects of alcohol (including moderate drinking recommendations) along with related worksheets, feedback materials, and links to resources for drinking. Once a version of BecomeAnEX is developed that specifically addresses HD (called EX-HD), the investigators will conduct a one-arm open pilot of the site with 30 HD smokers recruited from newly registered BecomeAnEX users. The study will gather participant feedback on the site as well as site use metrics (e.g., number of logins, number of pages viewed, use of interactive components) and will revise EX-HD in response to this feedback in preparation for Stage 1b work. Stage 1b will use the updated EX-HD version to run a small scale randomized clinical trial where 120 participants will be randomly assigned to the standard version of BecomeAnEX or to EX-HD.
Interventions
BEHAVIORALStandard Web-based Smoking Cessation
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
BEHAVIORALAlcohol-focused Web-Based Smoking Cessation
A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Sponsors
Truth Initiative
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. current daily smoking of at least one cigarette per day 2. meeting NIAAA criteria for past month heavy or at-risk drinking (for women: drinking 8+ drinks per week or consuming 4+ drinks on one occasion at least once in the past month; for men: drinking 15+ drinks per week or consuming 5+ drinks on one occasion at least once in the past month) 3. age 18 or older 4. willingness to provide contact and mailing information following consent
Exclusion criteria
1\. history of severe alcohol withdrawal as indicated by past alcohol-induced seizures or delirium tremens;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month | 1 month after enrollment | Self-report abstinence from smoking |
| Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months | 6 months after enrollment | Self-report abstinence from smoking |
| Number of Heavy Drinking Days at 1 Month | 1 month after enrollment | Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men |
| Number of Heavy Drinking Days at 6 Months | 6 months after enrollment | Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men |
Countries
United States
Participant flow
Recruitment details
Study recruitment was conducted online over 7 weeks (May to July, 2017). Only newly registered users of BecomeAnEX.org were recruited.
Participants by arm
| Arm | Count |
|---|---|
| Standard Web-based Smoking Cessation A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
Standard Web-based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. | 61 |
| Alcohol-focused Web-Based Smoking Cessation A modified version of the website and text messaging program that is publicly available through BecomeAnEX.com. This version includes specific information and feedback on alcohol use, allows participants to consider benefits of changing drinking, plans for changing drinking, and strategies. Participants have access to the website whenever they wish.
Alcohol-focused Web-Based Smoking Cessation: A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish. | 58 |
| Total | 119 |
Baseline characteristics
| Characteristic | Alcohol-focused Web-Based Smoking Cessation | Total | Standard Web-based Smoking Cessation |
|---|---|---|---|
| Age, Continuous | 37.1 years STANDARD_DEVIATION 10.6 | 38.0 years STANDARD_DEVIATION 11.8 | 38.6 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 115 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 98 Participants | 50 Participants |
| Sex: Female, Male Female | 41 Participants | 83 Participants | 42 Participants |
| Sex: Female, Male Male | 17 Participants | 36 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 58 |
| other Total, other adverse events | 0 / 61 | 0 / 58 |
| serious Total, serious adverse events | 0 / 61 | 0 / 58 |
Outcome results
Primary
Number of Heavy Drinking Days at 1 Month
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Time frame: 1 month after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Web-based Smoking Cessation | Number of Heavy Drinking Days at 1 Month | 2.9 Days | Standard Deviation 4.7 |
| Alcohol-focused Web-Based Smoking Cessation | Number of Heavy Drinking Days at 1 Month | 4.4 Days | Standard Deviation 6.3 |
p-value: 0.36t-test, 2 sided
Primary
Number of Heavy Drinking Days at 6 Months
Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men
Time frame: 6 months after enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Web-based Smoking Cessation | Number of Heavy Drinking Days at 6 Months | 2.6 Days | Standard Deviation 3.5 |
| Alcohol-focused Web-Based Smoking Cessation | Number of Heavy Drinking Days at 6 Months | 3.8 Days | Standard Deviation 6.7 |
p-value: 0.92t-test, 2 sided
Primary
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month
Self-report abstinence from smoking
Time frame: 1 month after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Web-based Smoking Cessation | Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month | 10 Participants |
| Alcohol-focused Web-Based Smoking Cessation | Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month | 10 Participants |
p-value: 0.9Chi-squared
Primary
Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months
Self-report abstinence from smoking
Time frame: 6 months after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Web-based Smoking Cessation | Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months | 9 Participants |
| Alcohol-focused Web-Based Smoking Cessation | Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months | 11 Participants |
p-value: 0.54Chi-squared