Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-01

Study Completion Date

2014-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm I - Memantine

Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.

Group Type ACTIVE_COMPARATOR

memantine hydrochloride

Intervention Type DRUG

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.

Arm II - Placebo

Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo by mouth through completion of 12 weeks.

Interventions

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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.

Intervention Type DRUG

placebo

Placebo by mouth through completion of 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Memantine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No