|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Roswell Park Cancer Institute |
|---|---|
| Information provided by (Responsible Party): | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00534001 |
Purpose
RATIONALE: Bupropion may help people stop smoking by decreasing the symptoms of nicotine withdrawal. Giving bupropion over a longer period of time may be effective in helping people stop smoking.
PURPOSE: This randomized phase II trial is studying how well bupropion works in helping adults stop smoking.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Tobacco Use Disorder |
Drug: bupropion hydrochloride Other: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Phase II Study of the Effects of Extended Pre-Cessation Bupropion for Smoking Cessation |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2006 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (1-week run-in)
Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.
|
Drug: bupropion hydrochloride
Given orally
Other: placebo
Given orally
|
|
Experimental: Arm II (4-week run-in)
Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.
|
Drug: bupropion hydrochloride
Given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: Participants are stratified according to gender. Participants are randomized to 1 of 2 pre-cessation intervention arms.
In both arms, participants are asked to quit smoking (target quit date) in week 5. All participants then receive oral bupropion hydrochloride once or twice daily in weeks 5-11 and undergo 90-minute behavioral group counseling sessions once in weeks 5, 7, and 9.
Participants complete questionnaires to collect information on tobacco use history, health habits, depression, anxiety scales/symptoms, and sociodemographics at baseline. Participants also complete a series of validated questionnaires about smoking patterns, smoking satisfaction, mental health, personality traits, interpersonal skills, demand simulation, impulsivity, motivation, and perceived stress at baseline and then periodically during study. Participants undergo saliva sample collection at baseline and then periodically during study. Samples are analyzed for the presence of cotinine. Buccal cells are also collected at baseline for subsequent DNA analyses. Cigarette butts from the first cigarette of the day, including the quit day, are collected during group counseling sessions in weeks 1, 2, 4, and 5 and are assessed for a marker that indicates the amount of nicotine and tar consumed.
After finishing study treatment, participants are followed at 6 and 12 months.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Principal Investigator: | Martin Mahoney, MD | Roswell Park Cancer Institute |
More Information
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00534001 History of Changes |
| Other Study ID Numbers: | CDR0000565103, RPCI-I-57805 |
| Study First Received: | September 20, 2007 |
| Last Updated: | September 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
bladder cancer cervical cancer esophageal cancer gastric cancer renal cell carcinoma adult primary liver cancer non-small cell lung cancer small cell lung cancer pancreatic cancer |
hypopharyngeal cancer laryngeal cancer lip and oral cavity cancer nasopharyngeal cancer oropharyngeal cancer paranasal sinus and nasal cavity cancer adult acute myeloid leukemia tobacco use disorder |
|
Urinary Bladder Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Uterine Cervical Neoplasms Esophageal Diseases Esophageal Neoplasms Head and Neck Neoplasms Leukemia Liver Neoplasms Lung Neoplasms Stomach Neoplasms Pancreatic Neoplasms Tobacco Use Disorder Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Kidney Diseases Uterine Neoplasms Genital Neoplasms, Female Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Gastrointestinal Diseases |