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Maintaining Nonsmoking: Older Smokers - 1

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ClinicalTrials.gov Identifier: NCT00086385
Recruitment Status : Completed
First Posted : July 7, 2004
Results First Posted : October 10, 2013
Last Update Posted : March 23, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study was to examine pharmacological and psychological interventions for smokers over 50.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Nicotine polacrilex, Bupropion Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintaining Nonsmoking: Older Smokers
Study Start Date : September 2001
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Brief Treatment

Pharmacological Treatment - Subjects received 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment (NRT)

Brief Counseling - The counseling intervention consisted of five 90-minute group meetings.

There was no further treatment during Weeks 12-52.

 Drug: Nicotine polacrilex, Bupropion
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
Other Name: Nicorette, Zyban
Experimental: Extended NRT

Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition would continue receiving NRT for up to 52 weeks. Subjects in this condition would be encouraged to continue NRT through Week 24. If a subject terminated NRT and resumed smoking, before Week 50, would be instructed to set a quit date and resume NRT.

Counseling Treatment - This is identical to the Brief Counseling described above.

 Drug: Nicotine polacrilex, Bupropion
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
Other Name: Nicorette, Zyban
Experimental: Tailored/No Extended NRT
This condition was identical to the Tailored/NRT condition except that no NRT was available after completion of the Brief Treatment.
 Drug: Nicotine polacrilex, Bupropion
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
Other Name: Nicorette, Zyban
Experimental: Extended Tailored Counseling + NRT
Tailored Counseling Treatment- The primary goal of the extended treatment was to prevent relapse. Secondary goal was to encourage initiation of abstinence for those who have not attained it by Week 12, and re-initiation of abstinence after slips. Subjects would participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session would occur at Week 10. Additional sessions would be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session would be 20-30 minutes long. Between sessions subjects would be contacted by phone for brief check-ins (5-10 minutes).
 Drug: Nicotine polacrilex, Bupropion
Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement.
Other Name: Nicorette, Zyban


Outcome Measures
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Primary Outcome Measures :
  1. Participants Abstinent From Cigarettes [ Time Frame: Two years ]
    Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

smokers of at least 10 cigarettes per day

Inclusion Criteria:

MULTIPLE

Exclusion Criteria:

MULTIPLE

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086385


Locations
United States, California
San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Sharon M Hall, Ph.D. University of California, San Francisco
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00086385     History of Changes
Other Study ID Numbers: NIDA-02538-1
R01DA002538 ( U.S. NIH Grant/Contract )
R01-02538-1
First Posted: July 7, 2004    Key Record Dates
Results First Posted: October 10, 2013
Last Update Posted: March 23, 2015
Last Verified: March 2015

Keywords provided by University of California, San Francisco:
Smoking cessation
Tobacco

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors