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Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Information source: Wake Forest NCORP Research Base
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer; Tobacco Use Disorder

Intervention: memantine hydrochloride (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Wake Forest NCORP Research Base

Official(s) and/or principal investigator(s):
John Spangler, MD, Principal Investigator, Affiliation: Comprehensive Cancer Center of Wake Forest University

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.

Clinical Details

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

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

Primary outcome:

Retention

Adherence

Secondary outcome:

Nicotine Dependence

Smoking Withdrawal

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Wake Forest Cancer Center CCOP Research Base, Winston Salem, North Carolina 27157, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: August 2012
Last updated: July 15, 2015

Page last updated: August 23, 2015

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