Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

NCT01535040 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB00020412U10CA081851REBACCCWFU 99311
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

cancer survivor; stage I non-small cell lung cancer; stage II non-small cell lung cancer; tobacco use disorder; 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

Outcome Measures

Primary Outcomes (2)

• Retention

  Retention is defined as the percentage of participants who complete the 12 week visit

  12 weeks

• Adherence

  Adherence is the percentage of prescribed pills taken while on therapy.

  12 weeks

Secondary Outcomes (2)

• Nicotine Dependence

  12 weeks

• Smoking Withdrawal

  12 weeks

Study Arms (2)

Arm I - Memantine

ACTIVE COMPARATOR

Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.

Drug: memantine hydrochloride

Arm II - Placebo

PLACEBO COMPARATOR

Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.

Drug: placebo

Interventions

memantine hydrochloride DRUG

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.

Also known as: Memantine

Arm I - Memantine

placebo DRUG

Placebo by mouth through completion of 12 weeks.

Arm II - Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Cancer Center CCOP Research Base

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Spangler J, Skidmore E, Dressler EV, Weaver KE, Lesser GJ, Burton G, Esparaz B, Gillett B, Shaw EG. Randomized Placebo-Controlled Trial of Memantine for Smoking Cessation (CCCWFU 99311). Cancer Control. 2025 Jan-Dec;32:10732748251336416. doi: 10.1177/10732748251336416. Epub 2025 May 8.

  PMID: 40340434 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Tobacco Use Disorder; Carcinoma, Non-Small-Cell Lung; Colonic Neoplasms; Rectal Neoplasms

Interventions

Memantine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue 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; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Doug Case
• Organization: Wake Forest NCORP Research Base

dcase@wakehealth.edu

(336) 716-1048

Study Officials

• John Spangler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 17, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: September 28, 2021
• Results First Posted: January 26, 2015

Record last verified: 2021-09

Locations

US (1)