Trial Outcomes & Findings for Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking (NCT NCT01535040)
NCT ID: NCT01535040
Last Updated: 2021-09-28
Results Overview
Retention is defined as the percentage of participants who complete the 12 week visit
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-09-28
Participant Flow
Participant milestones
| Measure |
Arm I - Memantine
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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.
|
Arm II - Placebo
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
|
Overall Study
COMPLETED
|
35
|
44
|
|
Overall Study
NOT COMPLETED
|
30
|
21
|
Reasons for withdrawal
| Measure |
Arm I - Memantine
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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.
|
Arm II - Placebo
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
10
|
|
Overall Study
Never Started
|
9
|
4
|
|
Overall Study
Toxicity
|
7
|
5
|
|
Overall Study
Multiple Reasons
|
1
|
1
|
Baseline Characteristics
Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking
Baseline characteristics by cohort
| Measure |
Arm I - Memantine
n=65 Participants
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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.
|
Arm II - Placebo
n=65 Participants
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
56 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
65 participants
n=7 Participants
|
130 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All randomized participants
Retention is defined as the percentage of participants who complete the 12 week visit
Outcome measures
| Measure |
Arm I - Memantine
n=65 Participants
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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.
|
Arm II - Placebo
n=65 Participants
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks.
|
|---|---|---|
|
Retention
|
53.8 percentage of participants
Interval 41.0 to 66.3
|
67.7 percentage of participants
Interval 54.9 to 78.8
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants who returned pill diaries.
Adherence is the percentage of prescribed pills taken while on therapy.
Outcome measures
| Measure |
Arm I - Memantine
n=48 Participants
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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.
|
Arm II - Placebo
n=52 Participants
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks.
|
|---|---|---|
|
Adherence
|
86.0 percentage of prescribed pills
Interval 0.0 to 100.0
|
93.0 percentage of prescribed pills
Interval 10.0 to 100.0
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who reported any data
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.
Outcome measures
| Measure |
Arm I - Memantine
n=64 Participants
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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.
|
Arm II - Placebo
n=65 Participants
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks.
|
|---|---|---|
|
Nicotine Dependence
|
5.29 units on a scale
Standard Error 0.30
|
4.83 units on a scale
Standard Error 0.28
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Participants who provided data at any time
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).
Outcome measures
| Measure |
Arm I - Memantine
n=63 Participants
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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.
|
Arm II - Placebo
n=64 Participants
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks.
|
|---|---|---|
|
Smoking Withdrawal
|
1.93 units on a scale
Standard Error 0.09
|
2.01 units on a scale
Standard Error 0.08
|
Adverse Events
Arm I - Memantine
Serious events: 5 serious events
Other events: 48 other events
Deaths: 0 deaths
Arm II - Placebo
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I - Memantine
n=57 participants at risk
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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.
|
Arm II - Placebo
n=59 participants at risk
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
1/57 • Number of events 4 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
0.00%
0/59 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.8%
1/57 • Number of events 1 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
0.00%
0/59 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Cardiac disorders
Hypertension
|
1.8%
1/57 • Number of events 1 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
3.4%
2/59 • Number of events 7 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Hepatobiliary disorders
Liver Dysfunction / Failure
|
0.00%
0/57 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
1.7%
1/59 • Number of events 1 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
General disorders
Pain
|
1.8%
1/57 • Number of events 1 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
0.00%
0/59 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Eye disorders
Retinal Tear
|
1.8%
1/57 • Number of events 2 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
0.00%
0/59 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
Other adverse events
| Measure |
Arm I - Memantine
n=57 participants at risk
Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.
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.
|
Arm II - Placebo
n=59 participants at risk
Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.
placebo: Placebo by mouth through completion of 12 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
24.6%
14/57 • Number of events 54 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
20.3%
12/59 • Number of events 38 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Psychiatric disorders
Confusion
|
17.5%
10/57 • Number of events 21 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
8.5%
5/59 • Number of events 9 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Gastrointestinal disorders
Constipation
|
26.3%
15/57 • Number of events 31 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
22.0%
13/59 • Number of events 27 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.6%
22/57 • Number of events 69 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
45.8%
27/59 • Number of events 72 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Gastrointestinal disorders
Diarrhea
|
10.5%
6/57 • Number of events 12 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
16.9%
10/59 • Number of events 15 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Ear and labyrinth disorders
Dizziness
|
28.1%
16/57 • Number of events 25 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
16.9%
10/59 • Number of events 22 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.1%
16/57 • Number of events 55 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
27.1%
16/59 • Number of events 40 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
General disorders
Fatigue
|
57.9%
33/57 • Number of events 83 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
42.4%
25/59 • Number of events 66 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
General disorders
Headache
|
33.3%
19/57 • Number of events 33 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
32.2%
19/59 • Number of events 33 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Cardiac disorders
Hypertension
|
22.8%
13/57 • Number of events 31 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
22.0%
13/59 • Number of events 37 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Renal and urinary disorders
Renal and Urinary Disorder - Other
|
1.8%
1/57 • Number of events 1 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
8.5%
5/59 • Number of events 15 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
General disorders
Somnolence
|
22.8%
13/57 • Number of events 23 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
13.6%
8/59 • Number of events 17 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
3/57 • Number of events 5 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
3.4%
2/59 • Number of events 2 • 4 months (3 months of treatment and 1 month following the end of treatment)
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place