Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01535040|
Recruitment Status : Completed
First Posted : February 17, 2012
Results First Posted : January 26, 2015
Last Update Posted : June 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Tobacco Use Disorder||Drug: memantine hydrochloride Drug: placebo||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, 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|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
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.
- Retention [ Time Frame: 12 weeks ]Retention is defined as the percentage of participants who complete the 12 week visit
- Adherence [ Time Frame: 12 weeks ]Adherence is the percentage of prescribed pills taken while on therapy.
- Nicotine Dependence [ Time Frame: 12 weeks ]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 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535040
|United States, North Carolina|
|Wake Forest Cancer Center CCOP Research Base|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||John Spangler, MD||Wake Forest University Health Sciences|