Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
Basic Trial Information
|Phase II||Biomarker/Laboratory analysis, Treatment||Completed||18 and over||NCI||CCCWFU 99311|
U10CA081851, WFU 09-10-14, NCT01535040
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.
Further Study Information
- 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).
- 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.
- 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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors
Wake Forest NCORP Research Base
- National Cancer Institute
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01535040
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.