Phase 2
N=236
Improving Smoking Cessation Outcomes in Heavy Drinkers - 1
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00107575 ↗Enrolled (actual)
236
Serious AEs
0.9%
Results posted
Jan 2010
Primary outcome: Primary: Smoking Abstinence at 26 Weeks — 21; 22 participants — p=>.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Standard treatment plus brief alcohol intervention (Behavioral); Standard treatment (ST) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Abstinence at 26 Weeks |
21; 22 | >.05 |
| PRIMARY Smoking Abstinence at 16 Weeks |
21; 21 | .18 |
| PRIMARY Smoking Abstinence at 8 Weeks |
37; 46 | .95 |
| PRIMARY Smoking Abstinence at 2 Weeks |
54; 67 | .76 |
| SECONDARY Alcohol Drinks Consumed Per Week Over a 2-week Period |
9.8; 8.2; 10.3; 8.4; 10.3; 9.1 | .027 sig |
Summary
To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00107575). 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.