Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
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.
Tobacco Use Disorder
Drug: memantine hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors|
- Retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Retention is defined as the percentage of participants who complete the 12 week visit
- Adherence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Adherence is the percentage of prescribed pills taken while on therapy.
- Nicotine Dependence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The Fagerstrom tolerance scale consists of 8 questions, each of which is scored on a 0 to 1 or 0 to 2 scale. The total score ranges from 0 to 11, with higher scores representing greater dependence.
- Smoking Withdrawal [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The Wisconsin Smoking Withdrawal Scale is a 28 item questionnaire that assesses nicotine withdrawal. It consists of seven subscales, each consisting of 3-5 questions all answered on a 0-4 scale. Subscale scores are the mean of the items comprising the scale. Some items are reverse scored. Higher scores indicate greater withdrawal symptoms. Subscales were scored if more than half the items were answered. A total score was calculated as the mean of the individual subscales (if more than half the subscales had scores).
|Study Start Date:||August 2012|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I - Memantine
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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.
Other Name: Memantine
Placebo Comparator: Arm II - Placebo
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
Placebo by mouth through completion of 12 weeks.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535040
|United States, North Carolina|
|Wake Forest Cancer Center CCOP Research Base|
|Winston Salem, North Carolina, United States, 27157|
|Principal Investigator:||John Spangler, MD||Comprehensive Cancer Center of Wake Forest University|