Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence (TACT2)
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|ClinicalTrials.gov Identifier: NCT01811940|
Recruitment Status : Completed
First Posted : March 15, 2013
Results First Posted : October 12, 2018
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence||Drug: Adderall-ER Drug: Topiramate Other: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||169 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: 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.
Other Name: Adderall extended release (MAS-ER)
Topiramate 100 mg bid.
Other Name: Topamax
Placebo Comparator: 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.
- Three Weeks of Cocaine Abstinence at End of Study [ Time Frame: assessed during 14 weeks of trial, presented for last 3 weeks ]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.
- Any Three Consecutive Weeks of Abstinence During Study [ Time Frame: 14 weeks of study or length of study participation ]The 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811940
|United States, New York|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Frances Levin, M.D.||Columbia University|
|Principal Investigator:||Kyle Kampman, MD||University of Pennsylvania|