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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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Tobacco Use Disorder
Drug: memantine hydrochloride
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Placebo-Controlled Phase 2 Pilot Study of Memantine (Namenda) for Smoking Cessation Among Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Wake Forest Cancer Center CCOP Research Base:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 130
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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
Placebo Comparator: Arm II
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
Drug: placebo
Placebo by mouth through completion of 12 weeks.
Other Name: placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535040

Locations
United States, North Carolina
Wake Forest Cancer Center CCOP Research Base
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Cancer Center CCOP Research Base
Investigators
Principal Investigator: John Spangler, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier: NCT01535040     History of Changes
Other Study ID Numbers: CCCWFU 99311, U10CA081851
Study First Received: February 14, 2012
Last Updated: November 21, 2013
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Cancer Center CCOP Research Base:
tobacco use disorder
cancer survivor
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage I prostate cancer
stage IIA prostate cancer
stage IIB prostate cancer
stage III prostate cancer
stage I colon cancer
stage IIA colon cancer
stage IIB colon cancer
stage IIC colon cancer
stage IIIA colon cancer
stage IIIB colon cancer
stage IIIC colon cancer
stage I rectal cancer
stage IIA rectal cancer
stage IIB rectal cancer
stage IIC rectal cancer
stage IIIA rectal cancer
stage IIIB rectal cancer
stage IIIC rectal cancer

Additional relevant MeSH terms:
Tobacco Use Disorder
Breast Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Breast Diseases
Chemically-Induced Disorders
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Intestinal Diseases
Intestinal Neoplasms
Lung Diseases
Mental Disorders
Neoplasms
Neoplasms by Site
Prostatic Diseases
Rectal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Skin Diseases
Substance-Related Disorders
Thoracic Neoplasms
Urogenital Neoplasms
Memantine
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on November 20, 2014