Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Wake Forest University (WFU)

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Tobacco Use Disorder

Lung Cancer

Prostate Cancer

Colorectal Cancer

Treatments

Drug: memantine hydrochloride

Drug: placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01535040

U10CA081851 (U.S. NIH Grant/Contract)

IRB00020412

REBACCCWFU 99311 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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