Phase 2
N=130
Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
Breast Cancer · Colorectal Cancer · Lung Cancer · Prostate Cancer · Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01535040 ↗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
| Outcome | Result | p-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
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.