Trial Outcomes & Findings for Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence (NCT NCT01811940)
NCT ID: NCT01811940
Last Updated: 2019-04-24
Results Overview
The number of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at the end of the study. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB) and corroborated by the urine toxicology samples collected 3 times per week.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
169 participants
Primary outcome timeframe
assessed during 14 weeks of trial, presented for last 3 weeks
Results posted on
2019-04-24
Participant Flow
169 individuals enrolled in the trial and entered a 1 week placebo lead-in. 42 participants were not randomized due to several reasons including 16 being considered to be placebo-responders and 18 being lost to follow-up. 127 participants were then randomized.
Participant milestones
| Measure |
Adderall-ER and Topiramate
Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.
Adderall-ER: MAS-ER 60mg/day
Topiramate: Topiramate 100 mg bid.
|
Placebo
Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.
Placebo: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
|
Overall Study
COMPLETED
|
42
|
37
|
|
Overall Study
NOT COMPLETED
|
22
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Adderall-ER and Topiramate
n=64 Participants
Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.
Adderall-ER: MAS-ER 60mg/day
Topiramate: Topiramate 100 mg bid.
|
Placebo
n=63 Participants
Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.
Placebo: Placebo
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
46 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=7 Participants
|
0 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
|
39 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
education
High School or less
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
education
Some College
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
education
College or graduate school
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
employment status
Full-time
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
employment status
Part-time
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
employment status
Unemployed/Other
|
32 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
employment status
not reported
|
10 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Currently married
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed during 14 weeks of trial, presented for last 3 weeksThe number of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at the end of the study. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB) and corroborated by the urine toxicology samples collected 3 times per week.
Outcome measures
| Measure |
Adderall-ER and Topiramate
n=64 Participants
Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.
Adderall-ER: MAS-ER 60mg/day
Topiramate: Topiramate 100 mg bid.
|
Placebo
n=63 Participants
Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.
Placebo: Placebo
|
|---|---|---|
|
Three Weeks of Cocaine Abstinence at End of Study
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 weeks of study or length of study participationThe proportion of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at any time during the 14 week trial. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB)and corroborated by the urine toxicology samples collected 3 times per week.
Outcome measures
| Measure |
Adderall-ER and Topiramate
n=64 Participants
Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.
Adderall-ER: MAS-ER 60mg/day
Topiramate: Topiramate 100 mg bid.
|
Placebo
n=63 Participants
Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.
Placebo: Placebo
|
|---|---|---|
|
Any Three Consecutive Weeks of Abstinence During Study
|
14 Participants
|
4 Participants
|
Adverse Events
Adderall-ER and Topiramate
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adderall-ER and Topiramate
n=64 participants at risk
Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.
Adderall-ER: MAS-ER 60mg/day
Topiramate: Topiramate 100 mg bid.
|
Placebo
n=63 participants at risk
Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.
Placebo: Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
1.6%
1/64 • Number of events 1 • collected during 14 weeks of trial or length of participation
|
0.00%
0/63 • collected during 14 weeks of trial or length of participation
|
|
General disorders
inpatient rehabilitation
|
1.6%
1/64 • Number of events 1 • collected during 14 weeks of trial or length of participation
|
1.6%
1/63 • Number of events 1 • collected during 14 weeks of trial or length of participation
|
|
General disorders
leg swelling/pain
|
0.00%
0/64 • collected during 14 weeks of trial or length of participation
|
1.6%
1/63 • Number of events 1 • collected during 14 weeks of trial or length of participation
|
Other adverse events
| Measure |
Adderall-ER and Topiramate
n=64 participants at risk
Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study.
Adderall-ER: MAS-ER 60mg/day
Topiramate: Topiramate 100 mg bid.
|
Placebo
n=63 participants at risk
Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm.
Placebo: Placebo
|
|---|---|---|
|
General disorders
headache
|
14.1%
9/64 • Number of events 9 • collected during 14 weeks of trial or length of participation
|
15.9%
10/63 • Number of events 10 • collected during 14 weeks of trial or length of participation
|
|
General disorders
insomnia
|
18.8%
12/64 • Number of events 12 • collected during 14 weeks of trial or length of participation
|
9.5%
6/63 • Number of events 6 • collected during 14 weeks of trial or length of participation
|
|
Respiratory, thoracic and mediastinal disorders
URI
|
12.5%
8/64 • Number of events 8 • collected during 14 weeks of trial or length of participation
|
14.3%
9/63 • Number of events 9 • collected during 14 weeks of trial or length of participation
|
|
Cardiac disorders
increased blood pressure
|
15.6%
10/64 • Number of events 10 • collected during 14 weeks of trial or length of participation
|
7.9%
5/63 • Number of events 5 • collected during 14 weeks of trial or length of participation
|
|
Gastrointestinal disorders
anorexia
|
14.1%
9/64 • Number of events 9 • collected during 14 weeks of trial or length of participation
|
7.9%
5/63 • Number of events 5 • collected during 14 weeks of trial or length of participation
|
|
General disorders
dry mouth
|
15.6%
10/64 • Number of events 10 • collected during 14 weeks of trial or length of participation
|
4.8%
3/63 • Number of events 3 • collected during 14 weeks of trial or length of participation
|
|
General disorders
fatigue
|
10.9%
7/64 • Number of events 7 • collected during 14 weeks of trial or length of participation
|
9.5%
6/63 • Number of events 6 • collected during 14 weeks of trial or length of participation
|
|
Gastrointestinal disorders
GI upset
|
14.1%
9/64 • Number of events 9 • collected during 14 weeks of trial or length of participation
|
4.8%
3/63 • Number of events 3 • collected during 14 weeks of trial or length of participation
|
|
General disorders
muscle aches
|
7.8%
5/64 • Number of events 5 • collected during 14 weeks of trial or length of participation
|
11.1%
7/63 • Number of events 7 • collected during 14 weeks of trial or length of participation
|
|
General disorders
paresthesia
|
9.4%
6/64 • Number of events 6 • collected during 14 weeks of trial or length of participation
|
7.9%
5/63 • Number of events 5 • collected during 14 weeks of trial or length of participation
|
|
General disorders
anxiety
|
9.4%
6/64 • Number of events 6 • collected during 14 weeks of trial or length of participation
|
6.3%
4/63 • Number of events 4 • collected during 14 weeks of trial or length of participation
|
|
General disorders
dizziness
|
10.9%
7/64 • Number of events 7 • collected during 14 weeks of trial or length of participation
|
4.8%
3/63 • Number of events 3 • collected during 14 weeks of trial or length of participation
|
|
General disorders
drowsiness
|
4.7%
3/64 • Number of events 3 • collected during 14 weeks of trial or length of participation
|
11.1%
7/63 • Number of events 7 • collected during 14 weeks of trial or length of participation
|
|
Gastrointestinal disorders
diarrhea
|
7.8%
5/64 • Number of events 5 • collected during 14 weeks of trial or length of participation
|
6.3%
4/63 • Number of events 4 • collected during 14 weeks of trial or length of participation
|
|
Gastrointestinal disorders
vomiting
|
7.8%
5/64 • Number of events 5 • collected during 14 weeks of trial or length of participation
|
3.2%
2/63 • Number of events 2 • collected during 14 weeks of trial or length of participation
|
|
Cardiac disorders
increased heart rate
|
6.2%
4/64 • Number of events 4 • collected during 14 weeks of trial or length of participation
|
4.8%
3/63 • Number of events 3 • collected during 14 weeks of trial or length of participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place