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NCT01535040 · REGISTRY CONDITION SEARCH

Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2021-09-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Retention

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outcome · POSTED

Adherence

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outcome · POSTED

Nicotine Dependence

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outcome · POSTED

Smoking Withdrawal

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
    intervention Names
    1. Drug: memantine hydrochloride
    label
    Arm I - Memantine
    type
    ACTIVE_COMPARATOR
  2. description
    Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
    intervention Names
    1. Drug: placebo
    label
    Arm II - Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I - Memantine
    description
    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.
    name
    memantine hydrochloride
    other Names
    1. Memantine
    type
    DRUG
  2. arm Group Labels
    1. Arm II - Placebo
    description
    Placebo by mouth through completion of 12 weeks.
    name
    placebo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
130
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Retention is defined as the percentage of participants who complete the 12 week visit
    measure
    Retention
    time Frame
    12 weeks
  2. description
    Adherence is the percentage of prescribed pills taken while on therapy.
    measure
    Adherence
    time Frame
    12 weeks
secondary Outcomes
  1. description
    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.
    measure
    Nicotine Dependence
    time Frame
    12 weeks
  2. description
    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).
    measure
    Smoking Withdrawal
    time Frame
    12 weeks
Full study description
brief 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.
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.
Source references
references
  1. citation
    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.
    pmid
    40340434
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      payload
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      id
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      occurrences
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        exact text
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        start
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      offset unit
      unicode_code_points
      query cond
      Small Intestine Cancer
      query disease state id
      ds-small-intestine-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
      source file sha256
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      source kind
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      source string sha256
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    Preserved source evidence · Not medical advice