TriangleNCT01535040 · STUDY IN CONTEXT
Memantine Hydrochloride in Helping Cancer Survivors 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
Retention is defined as the percentage of participants who complete the 12 week visit
Adherence is the percentage of prescribed pills taken while on therapy.
The Fagerstrom tolerance scale consists of 8 questions, each of which is scored on a 0 to 1 or 0 to 2 scale. The total score ranges from 0 to 11, with higher scores representing greater dependence.
The Wisconsin Smoking Withdrawal Scale is a 28 item questionnaire that assesses nicotine withdrawal. It consists of seven subscales, each consisting of 3-5 questions all answered on a 0-4 scale. Subscale scores are the mean of the items comprising the scale. Some items are reverse scored. Higher scores indicate greater withdrawal symptoms. Subscales were scored if more than half the items were answered. A total score was calculated as the mean of the individual subscales (if more than half the subscales had scores).
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-malignant-lung-neoplasm
- nct id
- NCT01535040
- trial label
- Memantine Hydrochloride in Helping Cancer Survivors 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-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0000
- source section id
- NCT01535040-om-0000
- source outcome index
- 0
- endpoint
- Retention
- endpoint definition
- Retention is defined as the percentage of participants who complete the 12 week visit
- time origin
- 12 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants
- 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-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0001
- source section id
- NCT01535040-om-0001
- source outcome index
- 1
- endpoint
- Adherence
- endpoint definition
- Adherence is the percentage of prescribed pills taken while on therapy.
- time origin
- 12 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who returned pill diaries.
- 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-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0002
- source section id
- NCT01535040-om-0002
- source outcome index
- 2
- endpoint
- Nicotine Dependence
- endpoint definition
- The Fagerstrom tolerance scale consists of 8 questions, each of which is scored on a 0 to 1 or 0 to 2 scale. The total score ranges from 0 to 11, with higher scores representing greater dependence.
- time origin
- 12 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who reported any data
- 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-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0003
- source section id
- NCT01535040-om-0003
- source outcome index
- 3
- endpoint
- Smoking Withdrawal
- endpoint definition
- The Wisconsin Smoking Withdrawal Scale is a 28 item questionnaire that assesses nicotine withdrawal. It consists of seven subscales, each consisting of 3-5 questions all answered on a 0-4 scale. Subscale scores are the mean of the items comprising the scale. Some items are reverse scored. Higher scores indicate greater withdrawal symptoms. Subscales were scored if more than half the items were answered. A total score was calculated as the mean of the individual subscales (if more than half the subscales had scores).
- time origin
- 12 weeks
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who provided data at any time
- 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-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I - Memantine
- regimen
- Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity. memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks.
- analyzed count
- 65
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535040-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II - Placebo
- regimen
- Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity. placebo: Placebo by mouth through completion of 12 weeks.
- analyzed count
- 65
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535040-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I - Memantine
- regimen
- Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity. memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks.
- analyzed count
- 48
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535040-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II - Placebo
- regimen
- Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity. placebo: Placebo by mouth through completion of 12 weeks.
- analyzed count
- 52
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535040-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I - Memantine
- regimen
- Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity. memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks.
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535040-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II - Placebo
- regimen
- Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity. placebo: Placebo by mouth through completion of 12 weeks.
- analyzed count
- 65
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535040-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I - Memantine
- regimen
- Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity. memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks.
- analyzed count
- 63
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535040-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT01535040
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II - Placebo
- regimen
- Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity. placebo: Placebo by mouth through completion of 12 weeks.
- analyzed count
- 64
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01535040-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-lung-neoplasm
- nct id
- NCT01535040
- harm key
- EG000
- source section id
- NCT01535040-ae
- event group key
- EG000
- event group label
- Arm I - Memantine
- serious affected
- 5
- serious at risk
- 57
- other affected
- 48
- other at risk
- 57
- frequency threshold
- 5
- collection period
- 4 months (3 months of treatment and 1 month following the end of treatment)
- event definition
- The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
- 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-malignant-lung-neoplasm
- nct id
- NCT01535040
- harm key
- EG001
- source section id
- NCT01535040-ae
- event group key
- EG001
- event group label
- Arm II - Placebo
- serious affected
- 3
- serious at risk
- 59
- other affected
- 51
- other at risk
- 59
- frequency threshold
- 5
- collection period
- 4 months (3 months of treatment and 1 month following the end of treatment)
- event definition
- The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
- 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