NCT00534001

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 30, 2017

Completed
Last Updated

May 30, 2017

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

September 20, 2007

Results QC Date

February 20, 2017

Last Update Submit

April 24, 2017

Conditions

Bladder CancerCervical CancerEsophageal CancerGastric CancerHead and Neck CancerKidney CancerLeukemiaLiver CancerLung CancerPancreatic CancerTobacco Use Disorder

Keywords

bladder cancercervical canceresophageal cancergastric cancerrenal cell carcinomaadult primary liver cancernon-small cell lung cancersmall cell lung cancerpancreatic cancerhypopharyngeal cancerlaryngeal cancerlip and oral cavity cancernasopharyngeal canceroropharyngeal cancerparanasal sinus and nasal cavity canceradult acute myeloid leukemiatobacco use disorder

Outcome Measures

Primary Outcomes (1)

  • Prequit Change in Cigarettes Per Day

    Prequit Change in Cigarettes Per Day

    3-Week PreQuit Drug Manipulation Phase

Secondary Outcomes (1)

  • Abstinence

    4 weeks

Study Arms (2)

Arm I (1-week run-in)

EXPERIMENTAL

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 hydrochlorideOther: placebo

Arm II (4-week run-in)

EXPERIMENTAL

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

Interventions

bupropion hydrochlorideDRUG

Given orally

Arm I (1-week run-in)Arm II (4-week run-in)
placeboOTHER

Given orally

Arm I (1-week run-in)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Currently smokes ≥ 15 cigarettes per day for at least 1 year * Motivated to quit smoking within the next 3 months PATIENT CHARACTERISTICS: * Willing to attend clinic visits * Willing to refrain from nicotine replacement therapy (NRT) use during study participation * Able to speak and read English fluently * Has a home telephone and plans to reside in Western New York for the next year * Not pregnant or nursing * Negative pregnancy test * Not planning a pregnancy * Fertile patients must use effective contraception during and for 3 months after study participation * No history of chronic renal or hepatic disease * No history of head trauma or seizure * No history of a seizure disorder, brain tumor, or CNS tumor * No history of or currently diagnosed bulimia or anorexia nervosa * No history of psychotic disorder * No diabetes requiring oral hypoglycemics or insulin * No excessive use of alcohol or alcoholism * No current addiction to opiates, cocaine, or stimulants * No poorly controlled hypertension (i.e., systolic blood pressure \[BP\] \> 170 mm Hg and/or diastolic BP \> 110 mm Hg) * No allergy to bupropion hydrochloride * No other surgical or medical condition that may significantly alter absorption, distribution, metabolism, or excretion of bupropion hydrochloride * No history of noncompliance to medical regimens * No other clinical contraindication * No major depressive disorder PRIOR CONCURRENT THERAPY: * At least 14 days since prior and no concurrent monoamine oxidase inhibitor * No recent discontinuation of a benzodiazepine * No concurrent Hypericum perforatum (St. John's wort) * No other concurrent drugs containing bupropion hydrochloride (e.g., Wellbutrin or Zyban) * No concurrent antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants or anorectics, or levodopa * No concurrent active treatment for cancer (e.g., chemotherapy or radiotherapy)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUterine Cervical NeoplasmsEsophageal NeoplasmsStomach NeoplasmsHead and Neck NeoplasmsKidney NeoplasmsLeukemiaLiver NeoplasmsLung NeoplasmsPancreatic NeoplasmsTobacco Use DisorderCarcinoma, Renal CellCarcinoma, HepatocellularCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaHypopharyngeal NeoplasmsLaryngeal NeoplasmsMouth NeoplasmsNasopharyngeal NeoplasmsOropharyngeal NeoplasmsLeukemia, Myeloid, Acute

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach DiseasesKidney DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLiver DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialCarcinoma, BronchogenicBronchial NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesMouth DiseasesNasopharyngeal DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Martin Mahoney
Organization
Roswell Park Cancer Institute
martin.mahoney@roswellpark.org
716-845-2300

Study Officials

  • Martin Mahoney, MD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 24, 2007

Study Start

January 1, 2006

Primary Completion

May 1, 2008

Study Completion

July 1, 2015

Last Updated

May 30, 2017

Results First Posted

May 30, 2017

Record last verified: 2015-08

Locations

US(1)