Maintaining Nonsmoking: Older Smokers - 1
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00086385 |
Recruitment Status
:
Completed
First Posted
: July 7, 2004
Results First Posted
: October 10, 2013
Last Update Posted
: March 23, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tobacco Use Disorder | Drug: Nicotine polacrilex, Bupropion | Phase 3 |
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 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
smokers of at least 10 cigarettes per day
Inclusion Criteria:
MULTIPLE
Exclusion Criteria:
MULTIPLE

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
United States, California | |
San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Sharon M Hall, Ph.D. | University of California, San Francisco |
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 |