Maintaining Nonsmoking: Older Smokers - 1
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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 |
- 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 |
smokers of at least 10 cigarettes per day
Inclusion Criteria:
MULTIPLE
Exclusion Criteria:
MULTIPLE
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00086385
| United States, California | |
| San Francisco | |
| San Francisco, California, United States, 94143 | |
| 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 Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Bupropion Nicotine Antidepressive Agents Antidepressive Agents, Second-Generation Autonomic Agents Central Nervous System Agents Cholinergic Agents Cholinergic Agonists |
Dopamine Agents Dopamine Uptake Inhibitors Ganglionic Stimulants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Nicotinic Agonists Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015