Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Memantine

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