Trial Outcomes & Findings for Clinical Trial of Topiramate for Cocaine Addiction (NCT NCT00685178)
NCT ID: NCT00685178
Last Updated: 2017-07-11
Results Overview
Percentage of cocaine positive urine samples as measured by Preston new use rule (50% reduction in cocaine metabolites from previous urine)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
Urine samples collected 3 times weekly from week 1 through 26
Results posted on
2017-07-11
Participant Flow
250 volunteers were consented and admitted into the study; however 171 were randomized into the study. 79 volunteers were excluded due to a variety of reasons including failure to attend, adverse events (not study related), incarceration, failure to comply with study procedures, insufficient cocaine positive urines, and pregnancy
Participant milestones
| Measure |
1 Topiramate + CR
topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
2 Topiramate + NonCR
Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
|
3 Placebo + CR
Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
4 Placebo + NonCR
placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
45
|
39
|
47
|
|
Overall Study
COMPLETED
|
27
|
26
|
27
|
33
|
|
Overall Study
NOT COMPLETED
|
13
|
19
|
12
|
14
|
Reasons for withdrawal
| Measure |
1 Topiramate + CR
topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
2 Topiramate + NonCR
Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
|
3 Placebo + CR
Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
4 Placebo + NonCR
placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
2
|
4
|
|
Overall Study
missed 3 consecutive methadone clin days
|
7
|
5
|
2
|
6
|
|
Overall Study
voluntary study discharge
|
4
|
5
|
1
|
1
|
|
Overall Study
incarcerated
|
1
|
3
|
7
|
0
|
|
Overall Study
administrative (disciplinary) discharge
|
0
|
1
|
0
|
2
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Clinical Trial of Topiramate for Cocaine Addiction
Baseline characteristics by cohort
| Measure |
1 Topiramate + CR
n=40 Participants
topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
2 Topiramate + NonCR
n=45 Participants
Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
|
4 Placebo + NonCR
n=39 Participants
placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
|
3 Placebo + CR
n=47 Participants
Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
171 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 7 • n=93 Participants
|
41 years
STANDARD_DEVIATION 7 • n=4 Participants
|
40 years
STANDARD_DEVIATION 8 • n=27 Participants
|
42 years
STANDARD_DEVIATION 7 • n=483 Participants
|
42 years
STANDARD_DEVIATION 7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
82 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
89 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=93 Participants
|
45 participants
n=4 Participants
|
39 participants
n=27 Participants
|
47 participants
n=483 Participants
|
171 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Urine samples collected 3 times weekly from week 1 through 26Population: This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.
Percentage of cocaine positive urine samples as measured by Preston new use rule (50% reduction in cocaine metabolites from previous urine)
Outcome measures
| Measure |
1 Topiramate + CR
n=40 Participants
topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
2 Topiramate + NonCR
n=45 Participants
Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
|
3 Placebo + CR
n=39 Participants
Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
4 Placebo + NonCR
n=47 Participants
placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
|
|---|---|---|---|---|
|
Proportion of Cocaine Positive Urine Samples Per Treatment Condition
|
45.4 percentage of positive urine samples
|
42.7 percentage of positive urine samples
|
53.5 percentage of positive urine samples
|
46.5 percentage of positive urine samples
|
SECONDARY outcome
Timeframe: 12 weeks (Weeks 8-20)Voucher earnings used as a measurement of contigency management (CM) or operate conditioning. Volunteers were rewarded vouchers of escalating monetary value for cocaine abstinence, as indicated by a cocaine negative urine sample. The first cocaine negative urine earned a $2.50 voucher, and the value increased by $1.50 for each subsequent cocaine negative sample. Volunteers were awarded a bonus of $10.00 for every three consecutive cocaine negative urine samples. Urine samples were collected 3 times per week, and vouchers were attainable between Weeks 8 and 20. Contingency management as a measurement of operant conditioning in which positive reinforcement is applied (in this case vouchers of monetary value) and cocaine abstinence
Outcome measures
| Measure |
1 Topiramate + CR
n=40 Participants
topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
2 Topiramate + NonCR
n=45 Participants
Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
|
3 Placebo + CR
n=39 Participants
Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
4 Placebo + NonCR
n=47 Participants
placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
|
|---|---|---|---|---|
|
Voucher Earnings
|
421.25 Dollars
Standard Error 79.58
|
343.26 Dollars
Standard Error 65.34
|
394.69 Dollars
Standard Error 72.06
|
203.51 Dollars
Standard Error 50.89
|
Adverse Events
1 Topiramate + CR
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
2 Topiramate + NonCR
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
3 Placebo + CR
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
4 Placebo + NonCR
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Topiramate + CR
n=40 participants at risk
topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
|
2 Topiramate + NonCR
n=45 participants at risk
Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
|
3 Placebo + CR
n=39 participants at risk
Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
4 Placebo + NonCR
n=47 participants at risk
placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
|
|---|---|---|---|---|
|
General disorders
Accidental CO Poisoning
|
2.5%
1/40 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/45 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/39 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/47 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Renal and urinary disorders
Transient Creatinine elevation
|
0.00%
0/40 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
2.2%
1/45 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/39 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/47 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Psychiatric disorders
Paranoid Psychosis
|
0.00%
0/40 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
2.2%
1/45 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/39 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/47 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/40 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
2.2%
1/45 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/39 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/47 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Gastrointestinal disorders
Transaminases elevated
|
5.0%
2/40 • Number of events 2 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/45 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/39 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/47 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/40 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/45 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
2.6%
1/39 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/47 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Eye disorders
Increased intraocular pressure
|
0.00%
0/40 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/45 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/39 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
2.1%
1/47 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Reproductive system and breast disorders
Pregnancy
|
0.00%
0/40 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/45 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/39 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
2.1%
1/47 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/40 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/45 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/39 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
2.1%
1/47 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.5%
1/40 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/45 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/39 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/47 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Cardiac disorders
Abnormal EKG
|
2.5%
1/40 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
2.2%
1/45 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/39 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
0.00%
0/47 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
Other adverse events
| Measure |
1 Topiramate + CR
n=40 participants at risk
topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
|
2 Topiramate + NonCR
n=45 participants at risk
Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
|
3 Placebo + CR
n=39 participants at risk
Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results
|
4 Placebo + NonCR
n=47 participants at risk
placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
4.4%
2/45 • Number of events 2 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
5.1%
2/39 • Number of events 3 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
4.3%
2/47 • Number of events 2 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
|
Cardiac disorders
ECG Abnormal
|
2.5%
1/40 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
6.7%
3/45 • Number of events 3 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
2.6%
1/39 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
2.1%
1/47 • Number of events 1 • 28 weeks (between Week 3 and Week 31)
Standard Terminology. Reported adverse events include particpants who were randomized into the study's conditions (topiramate + CR/NonCR; placebo + CR/NonCR), and of which were rated as being either possibly, probably, or definitely related to the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place