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Clinical Trial of Topiramate for Cocaine Addiction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00685178
First Posted: May 28, 2008
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: April 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: topiramate
Behavioral: Contingency Reinforcement
Drug: placebo + NonCR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    1 Topiramate + CR   2 Topiramate + NonCR   3 Placebo + CR   4 Placebo + NonCR
STARTED   40   45   39   47 
COMPLETED   27   26   27   33 
NOT COMPLETED   13   19   12   14 
Adverse Event                1                5                2                4 
missed 3 consecutive methadone clin days                7                5                2                6 
voluntary study discharge                4                5                1                1 
incarcerated                1                3                7                0 
administrative (disciplinary) discharge                0                1                0                2 
Pregnancy                0                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

4 Placebo + NonCR placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
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

Total Total of all reporting groups

Baseline Measures
   1 Topiramate + CR   2 Topiramate + NonCR   4 Placebo + NonCR   3 Placebo + CR   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   45   39   47   171 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      40 100.0%      45 100.0%      39 100.0%      47 100.0%      171 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 43  (7)   41  (7)   40  (8)   42  (7)   42  (7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      17  42.5%      22  48.9%      19  48.7%      24  51.1%      82  48.0% 
Male      23  57.5%      23  51.1%      20  51.3%      23  48.9%      89  52.0% 
Region of Enrollment 
[Units: Participants]
         
United States   40   45   39   47   171 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Cocaine Positive Urine Samples Per Treatment Condition   [ Time Frame: Urine samples collected 3 times weekly from week 1 through 26 ]

2.  Secondary:   Voucher Earnings   [ Time Frame: 12 weeks (Weeks 8-20) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Annie Umbricht
Organization: Johns Hopkins University
phone: 410-550-1917
e-mail: annieumbricht@jhu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00685178     History of Changes
Other Study ID Numbers: R01DA021808 ( U.S. NIH Grant/Contract )
First Submitted: May 23, 2008
First Posted: May 28, 2008
Results First Submitted: April 17, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017