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Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT01535040
First received: February 14, 2012
Last updated: November 21, 2013
Last verified: November 2013

February 14, 2012
November 21, 2013
August 2012
February 2014   (final data collection date for primary outcome measure)
Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adherence (proportion of pills taken while on treatment) [ Designated as safety issue: No ]
  • Accrual assessed as the number of participants accrued divided by the number of months the study was open [ Designated as safety issue: No ]
  • Retention assessed as proportion of participants who complete the 12-week treatment period [ Designated as safety issue: No ]
  • Participation estimated by the number of participants seen at each site who are randomized of those who met the eligibility criteria [ Designated as safety issue: No ]
  • Abstinence rate defined as self-reported one-week abstinence at 12 weeks post-randomization and the urine cotinine tests [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01535040 on ClinicalTrials.gov Archive Site
  • Nicotine withdrawal measured by the Wisconsin Smoking Withdrawal Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of life measured by the SF12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Toxicities assessed by the CTCAE version 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • Nicotine addiction will be assessed using the Wisconsin Inventory of Smoking Dependent Motives [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Nicotine addiction assessed by the Wisconsin Inventory of Smoking Dependent Motives [ Designated as safety issue: No ]
  • Nicotine withdrawal measured by the Wisconsin Smoking Withdrawal Scale [ Designated as safety issue: No ]
  • Quality of life measured by the SF12 [ Designated as safety issue: No ]
  • Toxicities assessed by the CTCAE version 4 [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Prostate Cancer
  • Tobacco Use Disorder
  • Drug: memantine hydrochloride
    Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks.
    Other Name: Memantine
  • Drug: placebo
    Placebo by mouth through completion of 12 weeks.
    Other Name: placebo
  • Active Comparator: Arm I
    Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
    Intervention: Drug: memantine hydrochloride
  • Placebo Comparator: Arm II
    Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
December 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01535040
CCCWFU 99311, U10CA081851
Yes
Wake Forest Cancer Center CCOP Research Base
Wake Forest Cancer Center CCOP Research Base
National Cancer Institute (NCI)
Principal Investigator: John Spangler, MD Comprehensive Cancer Center of Wake Forest University
Wake Forest Cancer Center CCOP Research Base
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP