Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

Tobacco Use Disorder Clinical Trial

Official title:

Improving Smoking Cessation Outcomes in Heavy Drinkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107575
• Other study ID #: NIDA-15534-1
• Secondary ID: R01-15534-1
• Status: Completed
• Phase: Phase 2
• First received: April 5, 2005
• Last updated: May 24, 2010
• Start date: August 2003
• Est. completion date: April 2008

Study information

• Verified date: May 2010
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: April 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholic Intoxication
• Tobacco Use Disorder

Intervention

Behavioral:
• Standard treatment plus brief alcohol intervention
Standard smoking cessation treatment with nicotine patch plus a brief alcohol-focused intervention

Other:
• Standard treatment (ST)
Behavioral smoking cessation counseling and nicotine patch.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Abstinence at 26 Weeks	7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt	26 weeks	No
Primary	Smoking Abstinence at 16 Weeks	7 days of smoking abstinence confirmed biochemically at 16 weeks	16 weeks	No
Primary	Smoking Abstinence at 8 Weeks	7 days of smoking abstinence confirmed biochemically at 8 weeks	8 weeks	No
Primary	Smoking Abstinence at 2 Weeks	7 days of smoking abstinence confirmed biochemically at 2 weeks	2 weeks	No
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.	At 2, 8, 16, and 26-week follow-ups	No