Maintaining Nonsmoking: Older Smokers - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00086385
First received: July 1, 2004
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Tobacco Use Disorder
Drug: Nicotine polacrilex, Bupropion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintaining Nonsmoking: Older Smokers

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Participants Abstinent From Cigarettes [ Time Frame: Two years ] [ Designated as safety issue: No ]
    Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104


Enrollment: 403
Study Start Date: September 2001
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

smokers of at least 10 cigarettes per day

Inclusion Criteria:

MULTIPLE

Exclusion Criteria:

MULTIPLE

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086385

Locations
United States, California
San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Sharon M Hall, Ph.D. University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional 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, R01-02538-1
Study First Received: July 1, 2004
Results First Received: July 29, 2013
Last Updated: August 2, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014