Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Phase 2

Completed

Conditions: Lung Cancer
Prostate Cancer
Breast Cancer
Colorectal Cancer
Tobacco Use Disorder

Interventions: Drug: placebo
Drug: memantine hydrochloride

Registration Number: NCT01535040

Lead Sponsor: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 130

Inclusion Criteria

Not provided

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II - Placebo	placebo	Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
Arm I - Memantine	memantine hydrochloride	Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Retention	12 weeks	Retention is defined as the percentage of participants who complete the 12 week visit
Adherence	12 weeks	Adherence is the percentage of prescribed pills taken while on therapy.

Secondary Outcome Measures

Name	Time	Method
Nicotine Dependence	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.
Smoking Withdrawal	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).