Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

Brown University

Status and phase

Completed

Phase 2

Conditions

Tobacco Use Disorder

Treatments

Behavioral: Standard treatment plus brief alcohol intervention

Other: Standard treatment (ST)

Study type

Interventional

Funder types

Other

Identifiers

NCT00107575

R01-15534-1

NIDA-15534-1

Details and patient eligibility

About

To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.

Full 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).

Enrollment

236 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

be at least 18 years of age
have smoked cigarettes regularly for at least one year
currently smoke at least 10 cigarettes a day
currently be using no other tobacco products or nicotine replacement therapy
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

meet full DSM-IV criteria for alcohol dependence in the past 12 months
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]
meet criteria for current dysthymia, major depression, or manic episode [past month]
are currently psychotic [past 12 months] or suicidal [suicidal ideation or intent in the past month]
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)
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).