NCT01535040

Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking

Completed Phase 2 Results posted Last updated 28 September 2021

What this trial tests

Phase 2 trial testing memantine hydrochloride in Breast Cancer in 130 participants. Completed in 1 February 2014.

Timeline

1 August 2012

Primary endpoint
1 February 2014

1 February 2014

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	130
Start date	1 August 2012
Primary completion	1 February 2014
Estimated completion	1 February 2014
Sites	1 location across United States

Drugs / interventions tested

• memantine hydrochloride — full drug profile →
• placebo

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Lung Cancer — all drugs for Lung Cancer →
• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Breast Cancer or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Retention Primary · 12 weeks

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

Group	Value	95% CI
Arm I - Memantine	53.8	41.0 – 66.3
Arm II - Placebo	67.7	54.9 – 78.8

Adherence Primary · 12 weeks

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

Group	Value	95% CI
Arm I - Memantine	86.0	0 – 100
Arm II - Placebo	93.0	10 – 100

Nicotine Dependence Secondary · 12 weeks

The Fagerstrom tolerance scale consists of 8 questions, each of which is scored on a 0 to 1 or 0 to 2 scale. The total score ranges from 0 to 11, with higher scores representing greater dependence.

Group	Value	95% CI
Arm I - Memantine	5.29	± 0.30
Arm II - Placebo	4.83	± 0.28

Smoking Withdrawal Secondary · 12 weeks

The Wisconsin Smoking Withdrawal Scale is a 28 item questionnaire that assesses nicotine withdrawal. It consists of seven subscales, each consisting of 3-5 questions all answered on a 0-4 scale. Subscale scores are the mean of the items comprising the scale. Some items are reverse scored. Higher scores indicate greater withdrawal symptoms. Subscales were scored if more than half the items were answered. A total score was calculated as the mean of the individual subscales (if more than half the subscales had scores).

Group	Value	95% CI
Arm I - Memantine	1.93	± 0.09
Arm II - Placebo	2.01	± 0.08

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 months (3 months of treatment and 1 month following the end of treatment). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm I - Memantine

Serious: 5/57 (9%)

Deaths: —

Arm II - Placebo

Serious: 3/59 (5%)

Deaths: —

Serious adverse events (6 terms)

Reaction	System	Arm I - Memantine	Arm II - Placebo
Hypertension	Cardiac disorders	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—
Fracture	Musculoskeletal and connective tissue disorders	—	—
Liver Dysfunction / Failure	Hepatobiliary disorders	—	—
Pain	General disorders	—	—
Retinal Tear	Eye disorders	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	Arm I - Memantine	Arm II - Placebo
Fatigue	General disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Headache	General disorders	—	—
Dizziness	Ear and labyrinth disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—
Hypertension	Cardiac disorders	—	—
Somnolence	General disorders	—	—
Confusion	Psychiatric disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Renal and Urinary Disorder - Other	Renal and urinary disorders	—	—
Vomiting	Gastrointestinal disorders	—	—

Most-reported serious reactions: Hypertension, Back Pain, Fracture, Liver Dysfunction / Failure, Pain, Retinal Tear.

Data from ClinicalTrials.gov NCT01535040 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Genome-wide meta-analysis of 241,258 adults accounting for smoking behaviour identifies novel loci for obesity traits.
   Justice AE, Winkler TW, Feitosa MF, Graff M, et al · · 2017 · cited 169× · PMID 28443625 · DOI 10.1038/ncomms14977
2. Randomized Placebo-Controlled Trial of Memantine for Smoking Cessation (CCCWFU 99311).
   Spangler J, Skidmore E, Dressler EV, Weaver KE, et al · · 2025 · PMID 40340434 · DOI 10.1177/10732748251336416