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← Cervical Cancer

NCT00666978 · STUDY IN CONTEXT

Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.

Source null

→

secondary · POSTED

Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31. The variants present in people in the slow genotype group include \*17, \*20, \*23,\*27, \*35, \*9, \*2, \*25, \*26, and \*4. The fast metabolizers have none of the variant alleles tested. Blood samples were collected for 3HC/COT ratio at Week 0.

This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm.

→

secondary · POSTED

We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.

Source null

→

secondary · POSTED

Analyzed CYP2A6 by genotype. The variants present in people in the slow genotype group include \*17, \*20, \*23,\*27, \*35, \*9, \*2, \*25, \*26, and \*4. The fast metabolizers have none of the variant alleles tested. Slow metabolizers have any reduction or loss of function variant. Fast metabolizers are \*1/\*1 genotype by exclusion.

This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm. Blood was unable to be analyzed for CYP2A6 genotype for 6 participants.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer
nct id
NCT00666978
trial label
Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
4
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    outcome key
    om-0000
    source section id
    NCT00666978-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months
    endpoint definition
    Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.
    time origin
    6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    outcome key
    om-0001
    source section id
    NCT00666978-om-0001
    source outcome index
    1
    endpoint
    Number of Slow and Fast Metabolizers by Metabolite Ratio
    endpoint definition
    Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31. The variants present in people in the slow genotype group include \*17, \*20, \*23,\*27, \*35, \*9, \*2, \*25, \*26, and \*4. The fast metabolizers have none of the variant alleles tested. Blood samples were collected for 3HC/COT ratio at Week 0.
    time origin
    Weeks 0
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    outcome key
    om-0002
    source section id
    NCT00666978-om-0002
    source outcome index
    2
    endpoint
    Number of Participants for Each CYP2B6 Allele
    endpoint definition
    We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.
    time origin
    Week 3
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    outcome key
    om-0003
    source section id
    NCT00666978-om-0003
    source outcome index
    3
    endpoint
    Number of Slow and Fast Metabolizers by Genotype
    endpoint definition
    Analyzed CYP2A6 by genotype. The variants present in people in the slow genotype group include \*17, \*20, \*23,\*27, \*35, \*9, \*2, \*25, \*26, and \*4. The fast metabolizers have none of the variant alleles tested. Slow metabolizers have any reduction or loss of function variant. Fast metabolizers are \*1/\*1 genotype by exclusion.
    time origin
    Week 0
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm. Blood was unable to be analyzed for CYP2A6 genotype for 6 participants.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Bupropion Arm
    regimen
    270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
    analyzed count
    270
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00666978-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo Arm
    regimen
    270 African American adults received placebo for 7 weeks in addition to health education counseling.
    analyzed count
    270
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00666978-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    outcome key
    om-0001
    arm key
    OG000
    arm label
    All Study Participants
    regimen
    All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.
    analyzed count
    450
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00666978-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Bupropion Arm
    regimen
    270 African American adults received bupropion (150mg bid)for 7 weeks in addition to health education counseling.
    analyzed count
    268
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00666978-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    outcome key
    om-0003
    arm key
    OG000
    arm label
    All Study Participants
    regimen
    All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling.
    analyzed count
    534
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00666978-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    harm key
    EG000
    source section id
    NCT00666978-ae
    event group key
    EG000
    event group label
    Bupropion Arm
    serious affected
    8
    serious at risk
    270
    other affected
    46
    other at risk
    270
    frequency threshold
    3
    collection period
    16 weeks
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer
    nct id
    NCT00666978
    harm key
    EG001
    source section id
    NCT00666978-ae
    event group key
    EG001
    event group label
    Placebo Arm
    serious affected
    13
    serious at risk
    270
    other affected
    29
    other at risk
    270
    frequency threshold
    3
    collection period
    16 weeks
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice