A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence (TACT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00421603
First received: January 10, 2007
Last updated: January 23, 2013
Last verified: January 2013
Results First Received: December 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: Adderall-XR and Topiramate
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited by local advertising (internet, print, radio, television, and subway) or by clinical referrals in the New York City metropolitan area between January 2007 and February 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to group assignment patients participated in a one week placebo lead-in.

Reporting Groups
  Description
Adderall-XR and Topiramate Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
Placebo Placebo daily dose

Participant Flow:   Overall Study
    Adderall-XR and Topiramate     Placebo  
STARTED     39     42  
COMPLETED     28 [1]   30 [1]
NOT COMPLETED     11     12  
[1] Completed all 14 week sof trial



  Baseline Characteristics
  Hide Baseline Characteristics

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
Adderall-XR and Topiramate Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
Placebo Placebo daily dose
Total Total of all reporting groups

Baseline Measures
    Adderall-XR and Topiramate     Placebo     Total  
Number of Participants  
[units: participants]
  39     42     81  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     39     42     81  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.5  ± 8.2     42.4  ± 8.9     42.1  ± 8.6  
Gender  
[units: participants]
     
Female     6     5     11  
Male     33     37     70  
Region of Enrollment  
[units: participants]
     
United States     39     42     81  



  Outcome Measures

1.  Primary:   Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report   [ Time Frame: 3 weeks of abstinence during 14 weeks of trial or for length of participation ]

2.  Primary:   Pattern of Cocaine Use as Measured by the TimeLine Followback   [ Time Frame: recorded daily for the 14 weeks of the trial or length of participation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
The two-arm placebo controlled design does not allow us to address whether both medications are necessary for efficacy. Potential limited treatment masking that occurred when giving two medications with distinctive adverse effect profiles.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Daniel Brooks
Organization: NYSPI
phone: 212-740-3205
e-mail: brooksd@nyspi.columbia.edu


No publications provided


Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00421603     History of Changes
Other Study ID Numbers: #5368, R01DA022217
Study First Received: January 10, 2007
Results First Received: December 13, 2012
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration