Breast CancerPhase 2NCT01535040
Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
A Phase 2 study testing memantine hydrochloride in people with Breast Cancer and Colorectal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Memantine hydrochloride may help people stop smoking by decreasing the symptoms of nicotine withdrawal. PURPOSE: This randomized, pilot phase II trial studies how effective memantine hydrochloride works compared to placebo in helping cancer survivors stop smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Lung Cancer
- What is being tested?
- memantine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2012to 1 Feb 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Survivors of non-metastatic breast, prostate, or colorectal cancer, or stage I/II non-small cell lung cancer
- Age ≥ 18
- Smoked 100 tobacco cigarettes over lifetime at time of first interview, have smoked 10 or more cigarettes per day on most days over the past month
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky ≥ 70%)
- Ability to understand and the willingness to sign a written informed consent document
- Agrees to adhere to the study protocol and attend the required clinic visits
- Negative serum pregnancy test within 10 days prior to registration in women with child-bearing potential; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- Women who are currently breast-feeding are not eligible for this study
Who cannot join
- Use of chewing tobacco, pipe tobacco, snuff, or any other non-cigarette tobacco product is not allowed
- No patients with clinically significant uncontrolled medical conditions (e.g., unstable angina, myocardial infarction, transient ischemic attack [TIA], or cerebral vascular accident [CVA]) within past 3 months
- Creatinine ≥ 2 times upper limit of normal (ULN) in last six months
- Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) ≥ 3 times ULN in last six months
- Current uncontrolled hypertension ≥ 160/90 mm Hg
- Excessive alcohol abuse defined as more than 5 drinks per day for men and 4 drinks per day for women
Show all 16Show fewer
- Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up
- History of allergic reactions attributed to memantine
- PRIOR CONCURRENT THERAPY:
- Six months post definitive treatment (except for ongoing hormonal or targeted therapies)
- Patients currently must not be taking Nicotine Replacement Therapy (NRT) and agree to not start NRT for the duration of the study
- Patients currently taking antidepressant or antianxiety medications must have been on a stable dose for 4 weeks prior to registration
- Patients currently receiving the following medications are not eligible: anticonvulsant agents (e.g., phenytoin, carbamazepine, gabapentin, etc.); antiparkinsonian agents (e.g., Levo Dopa, ropinirole); neuroleptic agents (e.g., risperidone, quetiapine); carbonic anhydrase inhibitors (e.g., Diamox® and Sequels®)
- Memantine should not be combined with other N-methyl d-aspartate (NMDA) antagonists (amantadine, ketamine, and dextromethorphan)
- Participants may not be receiving any other investigational agents
- No current use of illegal drugs or use of prescription medications for non-medical reasons
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Cancer Center CCOP Research Base
Winston-Salem, North Carolina, 27157
About this study
Official title: Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors
RATIONALE: Memantine hydrochloride may help people stop smoking by decreasing the symptoms of nicotine withdrawal.
PURPOSE: This randomized, pilot phase II trial studies how effective memantine hydrochloride works compared to placebo in helping cancer survivors stop smoking.
Read the detailed description
OBJECTIVES:
Primary
- Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (memantine hydrochloride) (10 mg twice daily) or a matching placebo for 12 weeks.
- Estimate the self-reported abstinence rates of patients who are randomized to memantine or a matching placebo for 12 weeks and obtain a preliminary estimate of the treatment effect (difference in abstinence rates between the two groups).
Secondary
- Nicotine addiction will be assessed using the Wisconsin Inventory of Smoking Dependent Motives.
- Nicotine withdrawal will be measured by the Wisconsin Smoking Withdrawal Scale.
- Quality of life will be measured by the SF12 questionnaire.
- Toxicities will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.
OUTLINE: This is a randomized, placebo-controlled, pilot study. Participants are stratified according to gender (male vs female). Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive memantine hydrochloride orally (PO) twice daily (BID) on days 1-81 in the absence of unacceptable toxicity.
- Arm II: Participants receive placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
Participants complete the Behavioral Risk Factor Surveillance Survey (BRFSS), the Self-reported Tobacco Abstinence, the Wisconsin Inventory of Smoking Dependent Motives, the Wisconsin Smoking Withdrawal Scale, SF-12 quality-of-life questionnaire, and the Fagerstrom Nicotine Tolerance Scale at baseline and every 2 weeks for 12 weeks during study.
Participants also undergo urine sample collection at weeks 4, 8, and 12 for cotinine test using the NicAlert test.
- Being tested
- memantine hydrochloride, placebo
- Keywords
- cancer survivor, stage I non-small cell lung cancer, stage II non-small cell lung cancer, tobacco use disorder, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer, stage III prostate cancer, stage I colon cancer, stage IIA colon cancer, stage IIB colon cancer, stage IIC colon cancer, stage IIIA colon cancer, stage IIIB colon cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Tobacco Use Disorder, Carcinoma, Non-Small-Cell Lung, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memantine hydrochlorideDrug
Also called Memantine
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.
placeboDrug
Placebo by mouth through completion of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm I - Memantine | Active comparator | Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity. Receives: Drug: memantine hydrochloride |
| Arm II - Placebo | Placebo comparator | Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Retention is defined as the percentage of participants who complete the 12 week visit
Measured: 12 weeks
Adherence
Adherence is the percentage of prescribed pills taken while on therapy.
Measured: 12 weeks
Secondary outcomes (2)
Nicotine Dependence
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.
Measured: 12 weeks
Smoking Withdrawal
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study start1 Aug 2012
- Primary completion1 Feb 2014
- Study completion1 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John Spangler, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535040
- Sponsor's protocol ID
- IRB00020412
- Other IDs
- U10CA081851, REBACCCWFU 99311
- Status last verified
- Sep 2021
- First submitted
- 14 Feb 2012
- Last updated
- 28 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Spangler J, Skidmore E, Dressler EV, Weaver KE, Lesser GJ, Burton G, Esparaz B, Gillett B, Shaw EG. Randomized Placebo-Controlled Trial of Memantine for Smoking Cessation (CCCWFU 99311). Cancer Control. 2025 Jan-Dec;32:10732748251336416. doi: 10.1177/10732748251336416. Epub 2025 May 8.
PubMed 40340434
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT01535040
- Acronym / sponsor ID
- IRB00020412
- Keywords
- cancer survivor, stage I non-small cell lung cancer, stage II non-small cell lung cancer, tobacco use disorder, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 1 Feb 2014 (actual)
- Study completion
- 1 Feb 2014 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 26 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Memantine hydrochloride may help people stop smoking by decreasing the symptoms of nicotine withdrawal.
PURPOSE: This randomized, pilot phase II trial studies how effective memantine hydrochloride works compared to placebo in helping cancer survivors stop smoking.
Detailed description
OBJECTIVES:
Primary
- Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (memantine hydrochloride) (10 mg twice daily) or a matching placebo for 12 weeks.
- Estimate the self-reported abstinence rates of patients who are randomized to memantine or a matching placebo for 12 weeks and obtain a preliminary estimate of the treatment effect (difference in abstinence rates between the two groups).
Secondary
- Nicotine addiction will be assessed using the Wisconsin Inventory of Smoking Dependent Motives.
- Nicotine withdrawal will be measured by the Wisconsin Smoking Withdrawal Scale.
- Quality of life will be measured by the SF12 questionnaire.
- Toxicities will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.
OUTLINE: This is a randomized, placebo-controlled, pilot study. Participants are stratified according to gender (male vs female). Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive memantine hydrochloride orally (PO) twice daily (BID) on days 1-81 in the absence of unacceptable toxicity.
- Arm II: Participants receive placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
Participants complete the Behavioral Risk Factor Surveillance Survey (BRFSS), the Self-reported Tobacco Abstinence, the Wisconsin Inventory of Smoking Dependent Motives, the Wisconsin Smoking Withdrawal Scale, SF-12 quality-of-life questionnaire, and the Fagerstrom Nicotine Tolerance Scale at baseline and every 2 weeks for 12 weeks during study.
Participants also undergo urine sample collection at weeks 4, 8, and 12 for cotinine test using the NicAlert test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I - Memantine | Active comparator | Drug: memantine hydrochlorideParticipants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity. |
| Arm II - Placebo | Placebo comparator | Drug: placeboParticipants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Survivors of non-metastatic breast, prostate, or colorectal cancer, or stage I/II non-small cell lung cancer
- Age ≥ 18
- Smoked 100 tobacco cigarettes over lifetime at time of first interview, have smoked 10 or more cigarettes per day on most days over the past month
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky ≥ 70%)
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (16 listed)
- Use of chewing tobacco, pipe tobacco, snuff, or any other non-cigarette tobacco product is not allowed
- No patients with clinically significant uncontrolled medical conditions (e.g., unstable angina, myocardial infarction, transient ischemic attack [TIA], or cerebral vascular accident [CVA]) within past 3 months
- Creatinine ≥ 2 times upper limit of normal (ULN) in last six months
- Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) ≥ 3 times ULN in last six months
- Current uncontrolled hypertension ≥ 160/90 mm Hg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| memantine hydrochlorideAlso: MemantineEstimate 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. | Drug | Arm I - Memantine |
| placeboPlacebo by mouth through completion of 12 weeks. | Drug | Arm II - Placebo |
Primary outcome
Retention
Time frame: 12 weeks
Retention is defined as the percentage of participants who complete the 12 week visit
Adherence
Time frame: 12 weeks
Adherence is the percentage of prescribed pills taken while on therapy.
2 secondary outcomes
Nicotine Dependence
Time frame: 12 weeks
Smoking Withdrawal
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40340434Spangler J, Skidmore E, Dressler EV, Weaver KE, Lesser GJ, Burton G, Esparaz B, Gillett B, Shaw EG. Randomized Placebo-Controlled Trial of Memantine for Smoking Cessation (CCCWFU 99311). Cancer Control. 2025 Jan-Dec;32:10732748251336416. doi: 10.1177/10732748251336416. Epub 2025 May 8.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Spangler, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing memantine hydrochloride in people with Breast Cancer and Colorectal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01535040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.