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

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


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

Drug Information available for: Nicotine tartrate Bupropion hydrochloride Bupropion Nicotine polacrilex

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
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

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

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

Barnett PG, Wong W, Jeffers A, Munoz R, Humfleet G, Hall S. Cost-effectiveness of extended cessation treatment for older smokers. Addiction. 2014 Feb;109(2):314-22. doi: 10.1111/add.12404. Epub 2013 Dec 13.

Hall SM, Humfleet GL, Muñoz RF, Reus VI, Robbins JA, Prochaska JJ. Extended treatment of older cigarette smokers. Addiction. 2009 Jun;104(6):1043-52. doi: 10.1111/j.1360-0443.2009.02548.x. Epub 2009 Apr 9. Erratum in: Addiction. 2011 Jun;106(6):1204.


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

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