Trial Outcomes & Findings for Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1 (NCT NCT00218387)
NCT ID: NCT00218387
Last Updated: 2019-04-10
Results Overview
Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-04-10
Participant Flow
Participant milestones
| Measure |
200mg Modafinil
200mg Modafinil
Modafinil: 200mg Modafinil
|
400mg Modafinil
400mg Modafinil
Modafinil: 400mg Modafinil
|
Matching Placebo
Matching Placebo
Matching Placebo: Matching Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
43
|
40
|
|
Overall Study
COMPLETED
|
25
|
25
|
17
|
|
Overall Study
NOT COMPLETED
|
15
|
18
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1
Baseline characteristics by cohort
| Measure |
200mg Modafinil
n=40 Participants
200mg Modafinil
Modafinil: 200mg Modafinil
|
400mg Modafinil
n=43 Participants
400mg Modafinil
Modafinil: 400mg Modafinil
|
Matching Placebo
n=40 Participants
Matching Placebo
Matching Placebo: Matching Placebo
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 7.1 • n=99 Participants
|
40.4 years
STANDARD_DEVIATION 7.2 • n=107 Participants
|
40.0 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
39.8 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
94 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.
Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
Outcome measures
| Measure |
200mg Modafinil
n=25 Participants
200mg Modafinil
Modafinil: 200mg Modafinil
|
400mg Modafinil
n=25 Participants
400mg Modafinil
Modafinil: 400mg Modafinil
|
Matching Placebo
n=17 Participants
Matching Placebo
Matching Placebo: Matching Placebo
|
|---|---|---|---|
|
Number of Cocaine Non-use Days
No Alcohol Dependence
|
10.1 Number of Days
Standard Error 2.4
|
17.1 Number of Days
Standard Error 2.3
|
9.3 Number of Days
Standard Error 2.7
|
|
Number of Cocaine Non-use Days
Alcohol Dependence
|
14.1 Number of Days
Standard Error 2.5
|
9.4 Number of Days
Standard Error 2.5
|
12.8 Number of Days
Standard Error 2.4
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.
New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.
Outcome measures
| Measure |
200mg Modafinil
n=25 Participants
200mg Modafinil
Modafinil: 200mg Modafinil
|
400mg Modafinil
n=25 Participants
400mg Modafinil
Modafinil: 400mg Modafinil
|
Matching Placebo
n=17 Participants
Matching Placebo
Matching Placebo: Matching Placebo
|
|---|---|---|---|
|
Percent of Participants With New Use
No Alcohol Dependence
|
54.2 Percentage of participants
|
42.0 Percentage of participants
|
55.8 Percentage of participants
|
|
Percent of Participants With New Use
Alcohol Dependence
|
39.7 Percentage of participants
|
42.0 Percentage of participants
|
49.0 Percentage of participants
|
Adverse Events
200mg Modafinil
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
400mg Modafinil
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
200mg Modafinil
n=40 participants at risk
200mg Modafinil
Modafinil: 200mg Modafinil
|
400mg Modafinil
n=43 participants at risk
400mg Modafinil
Modafinil: 400mg Modafinil
|
Matching Placebo
n=40 participants at risk
Matching Placebo
Matching Placebo: Matching Placebo
|
|---|---|---|---|
|
Cardiac disorders
Heart Racing
|
12.5%
5/40 • Number of events 5
|
11.6%
5/43 • Number of events 6
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
Numbness
|
2.5%
1/40 • Number of events 1
|
4.7%
2/43 • Number of events 3
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Irritability
|
0.00%
0/40
|
0.00%
0/43
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
Headache
|
32.5%
13/40 • Number of events 17
|
37.2%
16/43 • Number of events 17
|
25.0%
10/40 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Muscle Ache
|
10.0%
4/40 • Number of events 4
|
2.3%
1/43 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
17.5%
7/40 • Number of events 7
|
27.9%
12/43 • Number of events 12
|
7.5%
3/40 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
12.5%
5/40 • Number of events 5
|
18.6%
8/43 • Number of events 8
|
12.5%
5/40 • Number of events 5
|
|
Infections and infestations
Upper Respiratory Infection
|
5.0%
2/40 • Number of events 2
|
4.7%
2/43 • Number of events 2
|
0.00%
0/40
|
|
Cardiac disorders
Rapid Heart Rate
|
7.5%
3/40 • Number of events 3
|
7.0%
3/43 • Number of events 3
|
0.00%
0/40
|
|
Psychiatric disorders
Sleepiness
|
2.5%
1/40 • Number of events 1
|
4.7%
2/43 • Number of events 3
|
15.0%
6/40 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Toothache
|
2.5%
1/40 • Number of events 1
|
0.00%
0/43
|
5.0%
2/40 • Number of events 2
|
|
Gastrointestinal disorders
Dry Mouth
|
2.5%
1/40 • Number of events 1
|
7.0%
3/43 • Number of events 3
|
0.00%
0/40
|
|
Gastrointestinal disorders
Heartburn
|
2.5%
1/40 • Number of events 1
|
4.7%
2/43 • Number of events 2
|
7.5%
3/40 • Number of events 3
|
|
Cardiac disorders
Chest Pain
|
5.0%
2/40 • Number of events 2
|
0.00%
0/43
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
Jitteriness
|
5.0%
2/40 • Number of events 3
|
0.00%
0/43
|
0.00%
0/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place