Trial Outcomes & Findings for Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence (NCT NCT00520286)
NCT ID: NCT00520286
Last Updated: 2017-04-07
Results Overview
Number of participant who abstained from methamphetamine from weeks 1 through 12
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
210 participants
Primary outcome timeframe
Weeks 1 - 12
Results posted on
2017-04-07
Participant Flow
Participant milestones
| Measure |
Modafinil
Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily
|
Placebo
Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
68
|
|
Overall Study
COMPLETED
|
76
|
36
|
|
Overall Study
NOT COMPLETED
|
66
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence
Baseline characteristics by cohort
| Measure |
Modafinil
n=142 Participants
Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily
|
Placebo
n=68 Participants
Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily
|
Total
n=210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.6 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
39 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
39 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
142 participants
n=5 Participants
|
68 participants
n=7 Participants
|
210 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1 - 12Number of participant who abstained from methamphetamine from weeks 1 through 12
Outcome measures
| Measure |
Modafinil
n=142 Participants
Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily
|
Placebo
n=68 Participants
Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily
|
|---|---|---|
|
Abstinence (Week 1 - 12)
Week 1
|
27 Participants
|
14 Participants
|
|
Abstinence (Week 1 - 12)
Week 2
|
38 Participants
|
13 Participants
|
|
Abstinence (Week 1 - 12)
Week 3
|
39 Participants
|
13 Participants
|
|
Abstinence (Week 1 - 12)
Week 4
|
46 Participants
|
15 Participants
|
|
Abstinence (Week 1 - 12)
Week 5
|
41 Participants
|
16 Participants
|
|
Abstinence (Week 1 - 12)
Week 6
|
39 Participants
|
15 Participants
|
|
Abstinence (Week 1 - 12)
Week 7
|
34 Participants
|
14 Participants
|
|
Abstinence (Week 1 - 12)
Week 8
|
40 Participants
|
16 Participants
|
|
Abstinence (Week 1 - 12)
Week 9
|
35 Participants
|
17 Participants
|
|
Abstinence (Week 1 - 12)
Week 10
|
34 Participants
|
14 Participants
|
|
Abstinence (Week 1 - 12)
Week 11
|
37 Participants
|
16 Participants
|
|
Abstinence (Week 1 - 12)
Week 12
|
34 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 21 daysNumber of subjects with 21 or more consecutive days of abstinence
Outcome measures
| Measure |
Modafinil
n=142 Participants
Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily
|
Placebo
n=68 Participants
Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily
|
|---|---|---|
|
Reduction of Craving
|
32 Participants
|
10 Participants
|
Adverse Events
Modafinil
Serious events: 0 serious events
Other events: 128 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Modafinil
n=142 participants at risk
Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily
|
Placebo
n=68 participants at risk
Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily
|
|---|---|---|
|
Infections and infestations
Leg infection
|
0.00%
0/142
|
1.5%
1/68 • Number of events 1
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/142
|
1.5%
1/68 • Number of events 1
|
|
Cardiac disorders
chest pain
|
0.00%
0/142
|
1.5%
1/68 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Celluitis
|
0.00%
0/142
|
1.5%
1/68 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome left forearm
|
0.00%
0/142
|
1.5%
1/68 • Number of events 1
|
Other adverse events
| Measure |
Modafinil
n=142 participants at risk
Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
Modafinil: 200 mg or 400 mg /daily
|
Placebo
n=68 participants at risk
Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks
Placebo: Placebo / daily
|
|---|---|---|
|
Nervous system disorders
Headache
|
42.3%
60/142 • Number of events 175
|
44.1%
30/68 • Number of events 63
|
|
Gastrointestinal disorders
Nausea
|
16.2%
23/142 • Number of events 32
|
11.8%
8/68 • Number of events 13
|
|
Vascular disorders
Hypertension
|
38.7%
55/142 • Number of events 104
|
33.8%
23/68 • Number of events 60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place