Clinical trial NCT00107575: Improving Smoking Cessation Outcomes in Heavy Drinkers - 1
Official title: Improving Smoking Cessation Outcomes in Heavy Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: tobacco
alcohol
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2005-04-06
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Smoking Abstinence at 26 Weeks
timeFrame: 26 weeks
measure: Smoking Abstinence at 16 Weeks
timeFrame: 16 weeks
measure: Smoking Abstinence at 8 Weeks
timeFrame: 8 weeks
measure: Smoking Abstinence at 2 Weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: Alcohol Drinks Consumed Per Week Over a 2-week Period
timeFrame: At 2, 8, 16, and 26-week follow-ups
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Christopher W Kahler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kahler CW, Metrik J, LaChance HR, Ramsey SE, Abrams DB, Monti PM, Brown RA. Addressing heavy drinking in smoking cessation treatment: a randomized clinical trial. J Consult Clin Psychol. 2008 Oct;76(5):852-62. doi: 10.1037/a0012717.