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Completed

NCT Number: NCT00107575

Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

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

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standard treatment plus brief alcohol intervention

Behavioral

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

Standard treatment (ST)

Other

Behavioral smoking cessation counseling and nicotine patch.

Primary outcomes

  1. Smoking Abstinence at 26 Weeks

    Time frame: 26 weeks

    7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt

  2. Smoking Abstinence at 16 Weeks

    Time frame: 16 weeks

    7 days of smoking abstinence confirmed biochemically at 16 weeks

  3. Smoking Abstinence at 8 Weeks

    Time frame: 8 weeks

    7 days of smoking abstinence confirmed biochemically at 8 weeks

  4. Smoking Abstinence at 2 Weeks

    Time frame: 2 weeks

    7 days of smoking abstinence confirmed biochemically at 2 weeks

Secondary outcomes

  1. Alcohol Drinks Consumed Per Week Over a 2-week Period

    Time frame: At 2, 8, 16, and 26-week follow-ups

    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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study title

Improving Smoking Cessation Outcomes in Heavy Drinkers

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Apr 6, 2005
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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