Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
This study is currently recruiting participants.
Verified April 2013 by Wake Forest Cancer Center CCOP Research Base
Sponsor:
Wake Forest Cancer Center CCOP Research Base
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT01535040
First received: February 14, 2012
Last updated: April 2, 2013
Last verified: April 2013
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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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Smoking
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535040
Contacts
| Contact: Robin Rosdhal, RN | (336) 713-6519 | rosdhal@wakehealth.edu |
Locations
| United States, North Carolina | |
| Wake Forest Cancer Center CCOP Research Base | Recruiting |
| Winston Salem, North Carolina, United States, 27157 | |
| Contact: Robin Rosdhal, RN 336-713-6519 rosdhal@wakehealth.edu | |
| Principal Investigator: John Spangler, MD | |
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: | April 2, 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Substance-Related Disorders Mental Disorders Memantine Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 22, 2013