Maintaining Nonsmoking: Older Smokers - 1 - Full Text View

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:

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

U.S. FDA Resources

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 (Adult, Senior)
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

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 R01-02538-1
Study First Received:	July 1, 2004
Results First Received:	July 29, 2013
Last Updated:	March 3, 2015
Health Authority:	United States: Federal Government

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 Bupropion Nicotine Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action	Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Nicotinic Agonists Cholinergic Agonists Cholinergic Agents

ClinicalTrials.gov processed this record on September 26, 2016