Trial Outcomes & Findings for Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2 (NCT NCT00134901)
NCT ID: NCT00134901
Last Updated: 2019-04-24
Results Overview
Mean number of cocaine using days per week based on self reported use verified by cocaine toxicology results.
COMPLETED
PHASE2
81 participants
weekly use during length of study participation
2019-04-24
Participant Flow
Individuals who applied for treatment at Columbia University's Substance Treatment and Research Service (STARS) outpatient clinic in New York City, USA, were recruited for this study. The study recruited from March 2003-February 2007.
patients entered a 2-week, single-blind placebo lead-in period. To be eligible for randomization, patients were required to attend at least 2 of 4 scheduled therapy sessions and to submit at least 4 of 6 scheduled urine samples during the two weeks of the lead-in period.
Participant milestones
| Measure |
Memantine
Memantine 40mg/day
|
Placebo
Placebo daily dose
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
42
|
|
Overall Study
COMPLETED
|
22
|
27
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
| Measure |
Memantine
Memantine 40mg/day
|
Placebo
Placebo daily dose
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
discontinued intervention
|
12
|
10
|
Baseline Characteristics
Effectiveness of Memantine in Treating Cocaine-Dependent Individuals - 2
Baseline characteristics by cohort
| Measure |
Memantine
n=39 Participants
Memantine 40mg/day
|
Placebo
n=42 Participants
Placebo daily dose
|
Total
n=81 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
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 7 • n=5 Participants
|
40 years
STANDARD_DEVIATION 9 • n=7 Participants
|
40 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
42 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weekly use during length of study participationMean number of cocaine using days per week based on self reported use verified by cocaine toxicology results.
Outcome measures
| Measure |
Memantine
n=39 Participants
Memantine 40mg/day
|
Placebo
n=42 Participants
Placebo daily dose
|
|---|---|---|
|
Weekly Cocaine Use
|
1.1 days
Standard Deviation 1.9
|
1.3 days
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: reported weekly cocaine use for 12 weeks/ or study participationPopulation: All analyses were performed on an intent-to-treat basis
A binary indicator of sustained abstinence, defined as three consecutive weeks of no cocaine use, obtained by self-report and verified using negative urine toxicology results, at any point of the trial;
Outcome measures
| Measure |
Memantine
n=39 Participants
Memantine 40mg/day
|
Placebo
n=42 Participants
Placebo daily dose
|
|---|---|---|
|
Cocaine Abstinence Based on Daily Self Reported Cocaine Use
|
15 participants
|
13 participants
|
Adverse Events
Memantine
Placebo
Serious adverse events
| Measure |
Memantine
n=39 participants at risk
Memantine 40mg/day
|
Placebo
n=42 participants at risk
Placebo daily dose
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/39
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
finger fracture
|
0.00%
0/39
|
2.4%
1/42 • Number of events 1
|
Other adverse events
| Measure |
Memantine
n=39 participants at risk
Memantine 40mg/day
|
Placebo
n=42 participants at risk
Placebo daily dose
|
|---|---|---|
|
Nervous system disorders
headache
|
12.8%
5/39 • Number of events 5
|
16.7%
7/42 • Number of events 7
|
|
General disorders
insomnia
|
7.7%
3/39 • Number of events 3
|
14.3%
6/42 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
muscle aches
|
5.1%
2/39 • Number of events 2
|
11.9%
5/42 • Number of events 5
|
|
General disorders
chills
|
0.00%
0/39
|
7.1%
3/42 • Number of events 3
|
|
General disorders
fever
|
0.00%
0/39
|
7.1%
3/42 • Number of events 3
|
|
General disorders
light headed
|
10.3%
4/39 • Number of events 4
|
7.1%
3/42 • Number of events 3
|
|
Psychiatric disorders
anxiety
|
5.1%
2/39 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
back ache
|
7.7%
3/39 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
GI upset
|
5.1%
2/39 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
nausea
|
5.1%
2/39 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
|
General disorders
drowsiness
|
7.7%
3/39 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
5.1%
2/39 • Number of events 2
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
5.1%
2/39 • Number of events 2
|
0.00%
0/42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place