TriangleNCT00666978 · 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
Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.
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.
We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.
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.
Reported safety
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-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-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