Trial Outcomes & Findings for Topiramate for the Treatment of Methamphetamine Dependence - 1 (NCT NCT00345371)
NCT ID: NCT00345371
Last Updated: 2017-03-27
Results Overview
The number of participants who abstained from methamphetamine from weeks 6 through 12
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
140 participants
Primary outcome timeframe
weeks 6 through 12
Results posted on
2017-03-27
Participant Flow
Participant milestones
| Measure |
Topiramate
Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate
|
Placebo Oral Tablet
After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
71
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
30
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topiramate for the Treatment of Methamphetamine Dependence - 1
Baseline characteristics by cohort
| Measure |
Topiramate
n=69 Participants
Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate
|
Placebo Oral Tablet
n=71 Participants
After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 8.83 • n=93 Participants
|
37.5 years
STANDARD_DEVIATION 8.47 • n=4 Participants
|
38 years
STANDARD_DEVIATION 8.62 • n=27 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=93 Participants
|
71 participants
n=4 Participants
|
140 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: weeks 6 through 12The number of participants who abstained from methamphetamine from weeks 6 through 12
Outcome measures
| Measure |
Topiramate
n=69 Participants
Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate
|
Placebo Oral Tablet
n=71 Participants
After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet
|
|---|---|---|
|
Abstinence (Weeks 6 - 12)
Week 6
|
49 Participants
|
49 Participants
|
|
Abstinence (Weeks 6 - 12)
Week 7
|
43 Participants
|
48 Participants
|
|
Abstinence (Weeks 6 - 12)
Week 8
|
46 Participants
|
45 Participants
|
|
Abstinence (Weeks 6 - 12)
Week 9
|
40 Participants
|
41 Participants
|
|
Abstinence (Weeks 6 - 12)
Week 10
|
38 Participants
|
33 Participants
|
|
Abstinence (Weeks 6 - 12)
Week 11
|
36 Participants
|
38 Participants
|
|
Abstinence (Weeks 6 - 12)
Week 12
|
34 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Weeks 1 through 12Number of participants who abstained from methamphetamine from weeks 1 through 12
Outcome measures
| Measure |
Topiramate
n=69 Participants
Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate
|
Placebo Oral Tablet
n=71 Participants
After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet
|
|---|---|---|
|
Abstinence (Weeks 1 - 12)
Week 1
|
58 Participants
|
53 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 2
|
56 Participants
|
50 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 3
|
55 Participants
|
50 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 4
|
55 Participants
|
50 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 5
|
56 Participants
|
51 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 6
|
49 Participants
|
49 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 7
|
43 Participants
|
48 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 8
|
46 Participants
|
45 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 9
|
40 Participants
|
41 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 10
|
38 Participants
|
33 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 11
|
36 Participants
|
38 Participants
|
|
Abstinence (Weeks 1 - 12)
Week 12
|
34 Participants
|
32 Participants
|
Adverse Events
Topiramate
Serious events: 3 serious events
Other events: 63 other events
Deaths: 0 deaths
Placebo Oral Tablet
Serious events: 8 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Topiramate
n=69 participants at risk
Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate
|
Placebo Oral Tablet
n=71 participants at risk
After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet
|
|---|---|---|
|
Psychiatric disorders
Superficial Cutting
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
|
Infections and infestations
Diverticulitis
|
1.4%
1/69 • Number of events 2
|
0.00%
0/71
|
|
Infections and infestations
Infected Boil
|
1.4%
1/69 • Number of events 1
|
0.00%
0/71
|
|
Cardiac disorders
Malignant hypertention (with angina)
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
|
Eye disorders
Visual Disturbance
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
|
Social circumstances
Assault
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
|
Cardiac disorders
Abnormal ECG
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/69
|
1.4%
1/71 • Number of events 1
|
Other adverse events
| Measure |
Topiramate
n=69 participants at risk
Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.
Topiramate
|
Placebo Oral Tablet
n=71 participants at risk
After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.
Placebo Oral Tablet
|
|---|---|---|
|
Nervous system disorders
Headache
|
47.8%
33/69 • Number of events 76
|
42.3%
30/71 • Number of events 68
|
|
General disorders
Fatigue
|
29.0%
20/69 • Number of events 22
|
19.7%
14/71 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.2%
16/69 • Number of events 18
|
15.5%
11/71 • Number of events 14
|
|
Gastrointestinal disorders
Diarrhea
|
15.9%
11/69 • Number of events 14
|
11.3%
8/71 • Number of events 12
|
|
Nervous system disorders
Dizziness
|
13.0%
9/69 • Number of events 10
|
7.0%
5/71 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place