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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA013490 | U.S. NIH Grant/Contract | View source | |
| DPMC | Other Identifier | NIDA |
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| Name | Class |
|---|---|
| Research Foundation for Mental Hygiene, Inc. | OTHER |
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The purpose of this study is to determine the efficacy and cost-effectiveness of long-term pharmacotherapy (using Zyban and/or nicotine replacement) for reducing the relapse rate associated with stopping smoking.
The goal of this study was to assess relapse prevention outcomes among individuals able to stop smoking when pharmacotherapy is extended beyond the standard duration of treatment. We hypothesized that maintenance treatment with prolonged bupropion use and/or "as needed" use of nicotine gum will reduce relapse to smoking. Participants were recruited through advertisements on radio, television, newspapers, the Internet, and various community outlets. Respondents were pre-screened by telephone using a standard interview. The first participant entered the OLT phase in February 2001; the final NTFU visit took place in October 2005.
The study was multi-phased consisting of: 1) eight-week open-label treatment (OLT) with bupropion and nicotine patch; 2) randomized double-blind assignment of OLT successes to 16 weeks of placebo-controlled maintenance treatment (MT); and 3) 24 weeks of non-treatment follow-up (NTFU). Participants received $25 compensation for completing the NTFU visits at Weeks 36 and 48. The Institutional Review Board of the New York State Psychiatric Institute approved the study. The study was performed at the Columbia University Medical Center Smoking Cessation Clinic in New York City.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupropion | Active Comparator | Bupropion (brand name Zyban Sustained Release). Participants used bupropion SR 150 mg twice daily during the 16-week maintenance treatment. |
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| Nicotine gum | Active Comparator | Nicotine gum (brand name Nicorette) During the maintenance 16-week maintenance treatment phase, participants assigned to this arm received 2 mg. nicotine gum. |
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| Bupropion+Nicotine Gum | Active Comparator | Combined active treatments: Bupropion (Zyban SR) and nicotine gum (Nicorette). Participants were instructed to use the 150 mg bupropion pill twice daily and the 2 mg. gum as needed during the 16-week maintenance treatment phase. |
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| Double placebo | Placebo Comparator | Placebo gum + placebo pill. Identical placebo pill was used twice daily and identical placebo gum was used as needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival abstinence rate with maintenance treatment | 48 weeks after start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lirio S. S Covey, Ph.D. | Research Foundation for Mental Hygiene, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17624979 | Result | Covey LS, Glassman AH, Jiang H, Fried J, Masmela J, LoDuca C, Petkova E, Rodriguez K. A randomized trial of bupropion and/or nicotine gum as maintenance treatment for preventing smoking relapse. Addiction. 2007 Aug;102(8):1292-302. doi: 10.1111/j.1360-0443.2007.01887.x. | |
| 18447101 | Result | Covey LS, Botello-Harbaum M, Glassman AH, Masmela J, LoDuca C, Salzman V, Fried J. Smokers' response to combination bupropion, nicotine patch, and counseling treatment by race/ethnicity. Ethn Dis. 2008 Winter;18(1):59-64. |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| 19023824 | Result | Covey LS, Manubay J, Jiang H, Nortick M, Palumbo D. Smoking cessation and inattention or hyperactivity/impulsivity: a post hoc analysis. Nicotine Tob Res. 2008 Dec;10(12):1717-25. doi: 10.1080/14622200802443536. |
| 19778993 | Result | Covey LS, Weissman J, LoDuca C, Duan N. A comparison of abstinence outcomes among gay/bisexual and heterosexual male smokers in an intensive, non-tailored smoking cessation study. Nicotine Tob Res. 2009 Nov;11(11):1374-7. doi: 10.1093/ntr/ntp137. Epub 2009 Sep 24. |
| 37230961 | Derived | Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6. |