Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535040
• Other study ID #: IRB00020412
• Secondary ID: U10CA081851REBAC
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2012
• Est. completion date: February 1, 2014

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 1, 2014
• Est. primary completion date: February 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

• Survivors of non-metastatic breast, prostate, or colorectal cancer, or stage I/II non-small cell lung cancer

• Age = 18

• Smoked 100 tobacco cigarettes over lifetime at time of first interview, have smoked 10 or more cigarettes per day on most days over the past month

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky = 70%)

• Ability to understand and the willingness to sign a written informed consent document

• Agrees to adhere to the study protocol and attend the required clinic visits

• Negative serum pregnancy test within 10 days prior to registration in women with child-bearing potential; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

• Women who are currently breast-feeding are not eligible for this study

Exclusion Criteria:

• Use of chewing tobacco, pipe tobacco, snuff, or any other non-cigarette tobacco product is not allowed

• No patients with clinically significant uncontrolled medical conditions (e.g., unstable angina, myocardial infarction, transient ischemic attack [TIA], or cerebral vascular accident [CVA]) within past 3 months

• Creatinine = 2 times upper limit of normal (ULN) in last six months

• Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvate transaminase (SGPT) = 3 times ULN in last six months

• Current uncontrolled hypertension = 160/90 mm Hg

• Excessive alcohol abuse defined as more than 5 drinks per day for men and 4 drinks per day for women

• Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up

• History of allergic reactions attributed to memantine

PRIOR CONCURRENT THERAPY:

• Six months post definitive treatment (except for ongoing hormonal or targeted therapies)

• Patients currently must not be taking Nicotine Replacement Therapy (NRT) and agree to not start NRT for the duration of the study

• Patients currently taking antidepressant or antianxiety medications must have been on a stable dose for 4 weeks prior to registration

• Patients currently receiving the following medications are not eligible:

anticonvulsant agents (e.g., phenytoin, carbamazepine, gabapentin, etc.); antiparkinsonian agents (e.g., Levo Dopa, ropinirole); neuroleptic agents (e.g., risperidone, quetiapine); carbonic anhydrase inhibitors (e.g., Diamox® and Sequels®)

• Memantine should not be combined with other N-methyl d-aspartate (NMDA) antagonists (amantadine, ketamine, and dextromethorphan)

• Participants may not be receiving any other investigational agents

• No current use of illegal drugs or use of prescription medications for non-medical reasons

Related Conditions & MeSH terms

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

Intervention

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.
• placebo
Placebo by mouth through completion of 12 weeks.

Locations

Country	Name	City	State
United States	Wake Forest Cancer Center CCOP Research Base	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Retention is defined as the percentage of participants who complete the 12 week visit	12 weeks
Primary	Adherence	Adherence is the percentage of prescribed pills taken while on therapy.	12 weeks
Secondary	Nicotine Dependence	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.	12 weeks
Secondary	Smoking Withdrawal	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).	12 weeks