Clinical trial NCT01535040
Conditions: Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Tobacco Use Disorder
Keywords: cancer survivor stage I non-small cell lung cancer stage II non-small cell lung cancer tobacco use disorder stage IA breast cancer stage IB breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage I prostate cancer stage IIA prostate cancer stage IIB prostate cancer stage III prostate cancer stage I colon cancer stage IIA colon cancer stage IIB colon cancer stage IIC colon cancer stage IIIA colon cancer stage IIIB colon cancer stage IIIC colon cancer stage I rectal cancer stage IIA rectal cancer stage IIB rectal cancer stage IIC rectal cancer stage IIIA rectal cancer stage IIIB rectal cancer stage IIIC rectal cancer
Sponsor: Wake Forest University Health Sciences
Start date: 2012-08-01; Completion date: 2014-02-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity. arm 2: Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
Interventions: intervention 1: memantine hydrochloride intervention 2: placebo
Intervention descriptions: intervention 1: 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 2: Placebo by mouth through completion of 12 weeks.

Protocol documents: