Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors
- 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
- 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
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.
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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.
John Spangler, MD
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
|Wake Forest Cancer Center CCOP Research Base||Winston Salem, North Carolina 27157|