Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
Condition: Breast Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer; Tobacco Use Disorder
MeSH terms: Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Tobacco Use Disorder
Intervention: memantine hydrochloride; placebo
Intervention 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.; Placebo by mouth through completion of 12 weeks.
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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; 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

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.
    

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