Maintaining Nonsmoking: Older Smokers - 1

Tobacco Use Disorder Clinical Trial

Official title:

Maintaining Nonsmoking: Older Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086385
• Other study ID #: NIDA-02538-1
• Secondary ID: R01DA002538R01-0
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2004
• Last updated: March 3, 2015
• Start date: September 2001
• Est. completion date: March 2009

Study information

• Verified date: March 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to examine pharmacological and psychological interventions for smokers over 50.

Description:

The overall goals of this line of research were to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse. The specific aims of the current study were to test a series of hypotheses about the efficacy and cost-effectiveness of long-term, tailored interventions in chronic, older smokers and the interaction of these interventions with gender and depression. Participants were 50 years or older and smoker 10 or more cigarettes per day. Baseline assessments includes measures of smoking behavior, nicotine dependence, depression diagnosis, demographics and life circumstances and measures of anger, depression and mood disturbance, stress, social support, health status, motivation for changed and drug and alcohol use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

smokers of at least 10 cigarettes per day

Inclusion Criteria:

MULTIPLE

Exclusion Criteria:

MULTIPLE

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Nicotine polacrilex, Bupropion
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.

Locations

Country	Name	City	State
United States	San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Abstinent From Cigarettes	Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104	Two years	No