Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01535040
Recruitment Status : Completed
First Posted : February 17, 2012
Results First Posted : January 26, 2015
Last Update Posted : September 7, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Tobacco Use Disorder Drug: memantine hydrochloride Drug: placebo Phase 2

Detailed Description:



  • 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).


  • 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors
Study Start Date : August 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Arm I - Memantine
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
Drug: 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.
Other Name: Memantine

Placebo Comparator: Arm II - Placebo
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
Drug: placebo
Placebo by mouth through completion of 12 weeks.

Primary Outcome Measures :
  1. Retention [ Time Frame: 12 weeks ]
    Retention is defined as the percentage of participants who complete the 12 week visit

  2. Adherence [ Time Frame: 12 weeks ]
    Adherence is the percentage of prescribed pills taken while on therapy.

Secondary Outcome Measures :
  1. Nicotine Dependence [ Time Frame: 12 weeks ]
    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.

  2. Smoking Withdrawal [ Time Frame: 12 weeks ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01535040

United States, North Carolina
Wake Forest Cancer Center CCOP Research Base
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Principal Investigator: John Spangler, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences Identifier: NCT01535040     History of Changes
Other Study ID Numbers: IRB00020412
U10CA081851 ( U.S. NIH Grant/Contract )
REBACCCWFU 99311 ( Other Identifier: NCI )
First Posted: February 17, 2012    Key Record Dates
Results First Posted: January 26, 2015
Last Update Posted: September 7, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
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
stage IIIC colon cancer
stage I rectal cancer
stage IIA rectal cancer
stage IIB rectal cancer
stage IIC rectal cancer
stage IIIA rectal cancer
stage IIIB rectal cancer
stage IIIC rectal cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Tobacco Use Disorder
Neoplasms by Site
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antiparkinson Agents