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Phase 2 N=130 Randomized Quadruple-blind Supportive Care

Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Breast Cancer · Colorectal Cancer · Lung Cancer · Prostate Cancer · Tobacco Use Disorder

Enrolled (actual)
130
Serious AEs
6.9%
Results posted
Jan 2015
Primary outcome: Primary: Retention — 53.8; 67.7 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
memantine hydrochloride (Drug); placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Feb 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Retention
53.8; 67.7
PRIMARY
Adherence
86.0; 93.0
SECONDARY
Nicotine Dependence
5.29; 4.83
SECONDARY
Smoking Withdrawal
1.93; 2.01

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01535040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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