Phase 4
N=96
Combination Nicotine Replacement for Alcoholic Smokers
Smoking · Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT00064844 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: 6 Month Smoking Abstinence — 20; 12 percentage of participants abstinent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cognitive Behavior Therapy for alcohol and smoking cessation (Behavioral); Nicoderm CQ nicotine patch (Drug); Placebo gum (Drug); Nicotine gum - Nicorette® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Month Smoking Abstinence |
20; 12 | — |
| PRIMARY 12 Month Smoking Abstinence |
13; 0 | <0.01 sig |
Summary
The overall objective of the study is to develop recommendations for treatment programs to help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco treatment program. The 175 patients will be divided into two groups. One group will receive an active nicotine patch and active nicotine gum. The other group will receive an active nicotine patch and placebo nicotine gum. Followup assessments will be conducted for 1-year from the beginning of treatment.
Eligibility Criteria
Inclusion criteria
- Males and females at least 18 years old.
- English speaking.
- Meets criteria for alcohol dependence or alcohol abuse.
- Must complete an alcohol detoxification program prior to entering the study.
- Currently smoking 15 or more cigarettes per day and have at least a 3 year history of smoking.
- Have a current desire to stop smoking and stop drinking.
- Willing to complete followup assessments up to 12 months after treatment.
- Willing to provide names of 2 people who can help locate the subject at followup and the name of one person who can verify information about alcohol and tobacco use.
- One person per household.
Exclusion Criteria
- Allergy to nicotine patch or nicotine gum.
- Weigh less than 100 pounds.
- Use other nicotine products, such as cigars, pipes or smokeless tobacco.
- Severe skin disorder.
- Active peptic ulcer.
- Active joint disease.
- Heart attack within 3 months prior to entering the study.
- Pregnant or breastfeeding female who are not on birth control.
- Currently taking medication to treat alcoholism or smoking, such as naltrexone, disulfiram or bupropion.
- Poor vision or hearing that would interfere with using a cell phone.
- Lack of transportation to the treatment site or live at least one hour from the treatment site.
- Homeless.
Data sourced from ClinicalTrials.gov (NCT00064844). 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.