Clinical trial · Interventional
Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Tobacco Use Disorder | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| memantine hydrochloride | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I - Memantine
- description
- Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
- interventionNames
- Drug: memantine hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Arm II - Placebo
- description
- Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
- interventionNames
- Drug: placebo
Primary outcomes (2)
- measure
- Retention
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: * 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 Exclusion Criteria: * 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 * 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
References
Publications (1)
- DERIVEDSpangler 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. PMID 40340434