TriangleNCT00790569 · STUDY IN CONTEXT
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program 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
Number of participants with self-reported, 7-day abstinence at 6-months
Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
Number of participants with self-reported 7-day abstinence at 12-months
Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.
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-lung-carcinoma
- nct id
- NCT00790569
- trial label
- Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program 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
- 6
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0000
- source section id
- NCT00790569-om-0000
- source outcome index
- 0
- endpoint
- Self- Reported 7-day Abstinence
- endpoint definition
- Number of participants with self-reported, 7-day abstinence at 6-months
- 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-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0001
- source section id
- NCT00790569-om-0001
- source outcome index
- 1
- endpoint
- Carbon Monoxide (CO)-Confirmed 7-day Abstinence
- endpoint definition
- Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.
- 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-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0002
- source section id
- NCT00790569-om-0002
- source outcome index
- 2
- endpoint
- Rates of Smoking Cessation Continuous From First Quit Day to 6 Months
- endpoint definition
- Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months
- 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-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0003
- source section id
- NCT00790569-om-0003
- source outcome index
- 3
- endpoint
- Self-reported 7-day Abstinence
- endpoint definition
- Number of participants with self-reported 7-day abstinence at 12-months
- time origin
- 12 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-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0004
- source section id
- NCT00790569-om-0004
- source outcome index
- 4
- endpoint
- CO-confirmed 7-day Abstinence
- endpoint definition
- Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
- time origin
- 12 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-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0005
- source section id
- NCT00790569-om-0005
- source outcome index
- 5
- endpoint
- Change in Smoking Urges
- endpoint definition
- Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.
- time origin
- 6 months
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I
- regimen
- Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. varenicline: Given orally
- analyzed count
- 137
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II
- regimen
- Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. placebo: Given orally
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Arm III
- regimen
- Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. nicotine: Given transdermally and orally
- analyzed count
- 133
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I
- regimen
- Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. varenicline: Given orally
- analyzed count
- 137
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II
- regimen
- Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. placebo: Given orally
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Arm III
- regimen
- Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. nicotine: Given transdermally and orally
- analyzed count
- 133
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I
- regimen
- Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. varenicline: Given orally
- analyzed count
- 137
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II
- regimen
- Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. placebo: Given orally
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Arm III
- regimen
- Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. nicotine: Given transdermally and orally
- analyzed count
- 133
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I
- regimen
- Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. varenicline: Given orally
- analyzed count
- 137
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II
- regimen
- Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. placebo: Given orally
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Arm III
- regimen
- Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. nicotine: Given transdermally and orally
- analyzed count
- 133
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00790569-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-lung-carcinoma
- nct id
- NCT00790569
- harm key
- EG000
- source section id
- NCT00790569-ae
- event group key
- EG000
- event group label
- Arm I
- serious affected
- 4
- serious at risk
- 137
- other affected
- 0
- other at risk
- 137
- frequency threshold
- 0
- collection period
- Source null
- 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-lung-carcinoma
- nct id
- NCT00790569
- harm key
- EG001
- source section id
- NCT00790569-ae
- event group key
- EG001
- event group label
- Arm II
- serious affected
- 2
- serious at risk
- 45
- other affected
- 0
- other at risk
- 45
- frequency threshold
- 0
- collection period
- Source null
- 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-lung-carcinoma
- nct id
- NCT00790569
- harm key
- EG002
- source section id
- NCT00790569-ae
- event group key
- EG002
- event group label
- Arm III
- serious affected
- 2
- serious at risk
- 133
- other affected
- 0
- other at risk
- 133
- frequency threshold
- 0
- collection period
- Source null
- 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