Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
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.
Checked against the public recordLast updated Sep 28, 2021 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.