NCT00365508 · STUDY IN CONTEXT

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit 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

24-hour Point Prevalence Abstinence at the 6-month Follow up

Intent to treat analysis (lost to follow-up = smoker)

→

secondary · POSTED

Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence

Intent to treat

→

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-pancreatic-cancer
nct id: NCT00365508
trial label: Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit 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: 2
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00365508
outcome key
om-0000
source section id
NCT00365508-om-0000
source outcome index
0
endpoint
24-hour Point Prevalence Abstinence at the 6-month Follow up
endpoint definition
24-hour Point Prevalence Abstinence at the 6-month Follow up
time origin
6-months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat analysis (lost to follow-up = smoker)
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
NCT00365508
outcome key
om-0001
source section id
NCT00365508-om-0001
source outcome index
1
endpoint
Rate of Compliance During the First 2 Weeks
endpoint definition
Applied to use of the intervention (number of lozenges/day or number of patches used per week) not considering abstinence
time origin
2 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Intent to treat
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
NCT00365508
outcome key
om-0000
arm key
OG000
arm label
Arm I
regimen
Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
analyzed count
321
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00365508-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00365508
outcome key
om-0000
arm key
OG001
arm label
Arm II
regimen
Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
analyzed count
321
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00365508-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00365508
outcome key
om-0001
arm key
OG000
arm label
Arm I
regimen
Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
analyzed count
321
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00365508-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00365508
outcome key
om-0001
arm key
OG001
arm label
Arm II
regimen
Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
analyzed count
321
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00365508-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00365508
harm key
EG000
source section id
NCT00365508-ae
event group key
EG000
event group label
Arm I
serious affected
4
serious at risk
321
other affected
0
other at risk
321
frequency threshold
1
collection period
6 months
event definition
Administered a checklist of side effects from NRT and collected any additional information on adverse events.
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
NCT00365508
harm key
EG001
source section id
NCT00365508-ae
event group key
EG001
event group label
Arm II
serious affected
7
serious at risk
321
other affected
0
other at risk
321
frequency threshold
1
collection period
6 months
event definition
Administered a checklist of side effects from NRT and collected any additional information on adverse events.
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