Clinical trial NCT01535040: Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
Official title: Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Tobacco Use Disorder
Keywords: cancer survivor
stage I non-small cell lung cancer
stage II non-small cell lung cancer
tobacco use disorder
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer
stage I colon cancer
stage IIA colon cancer
stage IIB colon cancer
stage IIC colon cancer
stage IIIA colon cancer
stage IIIB colon cancer
stage IIIC colon cancer
stage I rectal cancer
stage IIA rectal cancer
stage IIB rectal cancer
stage IIC rectal cancer
stage IIIA rectal cancer
stage IIIB rectal cancer
stage IIIC rectal cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-02-17
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility 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

Primary outcomes:
measure: Retention
timeFrame: 12 weeks
measure: Adherence
timeFrame: 12 weeks
Secondary outcomes:
measure: Nicotine Dependence
timeFrame: 12 weeks
measure: Smoking Withdrawal
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Cancer Center CCOP Research Base
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: John Spangler, MD
role: PRINCIPAL_INVESTIGATOR
References: