Spots Global Cancer Trial Database for Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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