NCT01535040

Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Colorectal Cancer
• Lung Cancer
• Prostate Cancer
• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	memantine hydrochloride	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.
DRUG	placebo	Placebo by mouth through completion of 12 weeks.

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-02-17
• Last updated: 2021-09-28
• Results posted: 2015-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study