Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedmemantine hydrochloride and placebo

The study team can explain what participation involves.

Who it may be forBreast Cancer · Colorectal Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 28, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

Study overview

What this study is about

Purpose: Supportive Care
Study type: Interventional
Phase: Phase 2
Sponsor: Wake Forest University Health Sciences
Interventions being studied: Drug: memantine hydrochloride; Drug: placebo

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Wake Forest Cancer Center CCOP Research BaseWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 28, 2021. Always confirm current availability with the study team.

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