Tobacco Use Disorder
Conditions
Keywords
tobacco, alcohol
Brief summary
To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.
Detailed description
Heavy alcohol use frequently co-occurs with cigarette smoking and may impede smoking cessation. This clinical trial examined whether smoking cessation treatment that incorporates brief alcohol intervention can improve smoking cessation outcomes (7-day verified point prevalence abstinence) and reduce drinks consumed per week. Heavy drinkers seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8-weeks of nicotine replacement therapy, either a 4-session standard smoking cessation treatment (ST, n = 119) or standard treatment of equal intensity that incorporated brief alcohol intervention (ST-BI, n = 117).
Interventions
BEHAVIORALStandard treatment plus brief alcohol intervention
Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention
Behavioral smoking cessation counseling and nicotine patch.
Sponsors
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
1. be at least 18 years of age 2. have smoked cigarettes regularly for at least one year 3. currently smoke at least 10 cigarettes a day 4. currently be using no other tobacco products or nicotine replacement therapy 5. currently drink heavily according to self-report (\>14 drinks per week or \>5 drinks per occasion at least once per month over the last 12 months for men; \>7 drinks per week or \>4 drinks per occasion at least once per month over the past 12 months for women)
Exclusion criteria
1. meet full DSM-IV criteria for alcohol dependence in the past 12 months 2. meet criteria for other current psychoactive substance abuse or dependence (excluding nicotine dependence and alcohol abuse) in the past 12 months \[this would also exclude individuals with lifetime substance dependence who continue to have some abuse/dependence symptoms in the past 12 months\] 3. meet criteria for current dysthymia, major depression, or manic episode \[past month\] 4. are currently psychotic \[past 12 months\] or suicidal \[suicidal ideation or intent in the past month\] 5. have an unstable medical condition that would suggest caution in the use of the nicotine patch (e.g., unstable angina pectoris, arrhythmia, recent congestive heart failure) 6. are currently pregnant or lactating or intend to become pregnant. We also will exclude participants who are not alcohol dependent but who have characteristics that might make supervised alcohol detoxification necessary (e.g., morning drinking to avoid withdrawal, daily drinking of \>12 drinks, recent withdrawal symptoms, history of severe withdrawal symptoms such as hallucinations, seizures, or delirium tremens).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence at 26 Weeks | 26 weeks | 7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt |
| Smoking Abstinence at 16 Weeks | 16 weeks | 7 days of smoking abstinence confirmed biochemically at 16 weeks |
| Smoking Abstinence at 8 Weeks | 8 weeks | 7 days of smoking abstinence confirmed biochemically at 8 weeks |
| Smoking Abstinence at 2 Weeks | 2 weeks | 7 days of smoking abstinence confirmed biochemically at 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Drinks Consumed Per Week Over a 2-week Period | At 2, 8, 16, and 26-week follow-ups | Average number of standard alcoholic drinks consumed per week over each 2-week period across the 26 weeks of follow-up as assessed by the Timeline Followback Interview. Standard alcoholic drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 ounces of liquor. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch | 119 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention | 117 |
| Total | 236 |
Baseline characteristics
| Characteristic | Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Standard Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical >=65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 112 Participants | 113 Participants | 225 Participants |
| Age, Continuous | 42.3 years STANDARD_DEVIATION 11.8 | 40.6 years STANDARD_DEVIATION 12.1 | 41.5 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 117 participants | 119 participants | 236 participants |
| Sex: Female, Male Female | 53 Participants | 53 Participants | 106 Participants |
| Sex: Female, Male Male | 64 Participants | 66 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 119 | 0 / 117 |
| serious Total, serious adverse events | 0 / 119 | 2 / 117 |
Outcome results
Primary
Smoking Abstinence at 16 Weeks
7 days of smoking abstinence confirmed biochemically at 16 weeks
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Treatment | Smoking Abstinence at 16 Weeks | 21 Participants |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Smoking Abstinence at 16 Weeks | 21 Participants |
p-value: 0.18Chi-squared
Primary
Smoking Abstinence at 26 Weeks
7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt
Time frame: 26 weeks
Population: For analyses of smoking outcomes, missing data were considered smoking. However, at 26 weeks, 2 participants in ST-BI had died and therefore their data was left as missing for this period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Treatment | Smoking Abstinence at 26 Weeks | 21 participants |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Smoking Abstinence at 26 Weeks | 22 participants |
p-value: >0.05Chi-squared
Primary
Smoking Abstinence at 2 Weeks
7 days of smoking abstinence confirmed biochemically at 2 weeks
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Treatment | Smoking Abstinence at 2 Weeks | 54 Participants |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Smoking Abstinence at 2 Weeks | 67 Participants |
p-value: 0.76Chi-squared
Primary
Smoking Abstinence at 8 Weeks
7 days of smoking abstinence confirmed biochemically at 8 weeks
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Treatment | Smoking Abstinence at 8 Weeks | 37 Participants |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Smoking Abstinence at 8 Weeks | 46 Participants |
p-value: 0.95Chi-squared
Secondary
Alcohol Drinks Consumed Per Week Over a 2-week Period
Average number of standard alcoholic drinks consumed per week over each 2-week period across the 26 weeks of follow-up as assessed by the Timeline Followback Interview. Standard alcoholic drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 ounces of liquor.
Time frame: At 2, 8, 16, and 26-week follow-ups
Population: The number of participants analyzed reflects the number of participants who provided at least some valid data on the Timeline Followback Interview
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 1-2 | 9.8 drinks | Standard Deviation 10 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 3-4 | 10.3 drinks | Standard Deviation 10.4 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 5-6 | 10.3 drinks | Standard Deviation 10.9 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 7-8 | 10.7 drinks | Standard Deviation 10.7 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 9-10 | 10.1 drinks | Standard Deviation 9.7 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 11-12 | 9.5 drinks | Standard Deviation 9.8 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 13-14 | 10.5 drinks | Standard Deviation 11.2 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 15-16 | 10.6 drinks | Standard Deviation 11 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 19-20 | 10.8 drinks | Standard Deviation 10.3 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 21-22 | 10.1 drinks | Standard Deviation 9.3 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 23-24 | 9.8 drinks | Standard Deviation 8.6 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 25-26 | 10.9 drinks | Standard Deviation 9.9 |
| Standard Treatment | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 17-18 | 10.9 drinks | Standard Deviation 10.3 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 13-14 | 8.6 drinks | Standard Deviation 9.1 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 1-2 | 8.2 drinks | Standard Deviation 9.9 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 21-22 | 9.1 drinks | Standard Deviation 11.2 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 3-4 | 8.4 drinks | Standard Deviation 10.8 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 15-16 | 9.2 drinks | Standard Deviation 9.6 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 5-6 | 9.1 drinks | Standard Deviation 11.1 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 17-18 | 9.0 drinks | Standard Deviation 10.3 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 7-8 | 9.6 drinks | Standard Deviation 11.2 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 25-26 | 10.0 drinks | Standard Deviation 13.3 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 9-10 | 9.1 drinks | Standard Deviation 9.8 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 19-20 | 9.8 drinks | Standard Deviation 11.8 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 11-12 | 9.2 drinks | Standard Deviation 10.3 |
| Standard Treatment Plus a Brief Alcohol Intervention (ST-BI) | Alcohol Drinks Consumed Per Week Over a 2-week Period | Drinks per week: Weeks 23-24 | 9.1 drinks | Standard Deviation 12 |
p-value: 0.02795% CI: [0.67, 0.98]generalized estimating equations