Improving Smoking Cessation Outcomes in Heavy Drinkers - 1

NCT00107575 | Completed Phase 2 Results

• 2 other identifiers: NIDA-15534-1R01-15534-1
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use Disorder

Keywords

tobacco; alcohol

Outcome Measures

Primary Outcomes (4)

• Smoking Abstinence at 26 Weeks

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

  26 weeks

• Smoking Abstinence at 16 Weeks

  7 days of smoking abstinence confirmed biochemically at 16 weeks

  16 weeks

• Smoking Abstinence at 8 Weeks

  7 days of smoking abstinence confirmed biochemically at 8 weeks

  8 weeks

• Smoking Abstinence at 2 Weeks

  7 days of smoking abstinence confirmed biochemically at 2 weeks

  2 weeks

Secondary Outcomes (1)

• Alcohol Drinks Consumed Per Week Over a 2-week Period

  At 2, 8, 16, and 26-week follow-ups

Study Arms (2)

Standard treatment (ST)

ACTIVE COMPARATOR

Standard smoking cessation treatment (ST)

Other: Standard treatment (ST)

ST-BI

EXPERIMENTAL

Standard treatment plus a brief alcohol intervention

Behavioral: Standard treatment plus brief alcohol intervention

Interventions

Standard treatment plus brief alcohol intervention BEHAVIORAL

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

ST-BI

Standard treatment (ST) OTHER

Behavioral smoking cessation counseling and nicotine patch.

Standard treatment (ST)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related 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.

  PMID: 18837602 RESULT

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Ethanol; Methods

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Results Point of Contact

• Title: Christopher Kahler
• Organization: Brown University

Christopher_Kahler@brown.edu

(401) 863-6651

Study Officials

• Christopher W Kahler, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: August 1, 2003
• Primary Completion: June 1, 2007
• Study Completion: April 1, 2008
• Last Updated: October 26, 2016
• Results First Posted: January 11, 2010

Record last verified: 2016-09

Locations

US (1)