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
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Condition or disease | Intervention/treatment | Phase |
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Cocaine Dependence | Drug: Adderall-ER Drug: Topiramate Other: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 169 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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Drug: Adderall-ER
MAS-ER 60mg/day
Other Name: Adderall extended release (MAS-ER) Drug: Topiramate 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.
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Other: Placebo
Placebo |
- 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.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women between the ages of 18-60 who meet DSM-IV criteria for cocaine dependence.
- Used cocaine at least 9 days in the past 28 days with at least weekly cocaine use.
- Able of giving informed consent and capable of complying with study procedures.
Exclusion Criteria:
- Meets DSM-IV-TR criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
- Individuals with any current Axis I psychiatric disorder as defined by DSM-IV-TR supported by the SCID-I/P that in the investigator's judgment are unstable, would be disrupted by study medication, or are likely to require pharmacotherapy or psychotherapy during the study period. Individuals who are currently stable on a psychotropic medication for at least 3 months may be included if in the investigator's opinion the psychotropic medication the patient is taking is compatible with the study medication (mixed amphetamine salts plus topiramate) and does not entail serious risk of adverse effects from the drug interactions. Individuals cannot be on any psychostimulants or other contraindicated medications.
- Individuals with a history of seizures or unexplained loss of consciousness
- History of allergic reaction to candidate medications (amphetamine or topiramate).
- Individuals with significant current suicidal risk.
- Women who are pregnant, nursing, or failure in sexually active female patients to use adequate contraceptive methods.
- Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP > 140, DBP> 90,or HR > 100 when sitting quietly), acute hepatitis(patients with chronic mildly elevated transaminases < 3x upper limit of normal are acceptable), or uncontrolled diabetes.
- Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG, cardiac symptoms, fainting, open-heart surgery and/or arrhythmia, and family history of ventricular tachycardia/sudden death.
- Individuals with use of carbonic anhydrase inhibitors
- History of glaucoma
- History of kidney stones
- Use of drugs that may be additive to the bicarbonate lowering effects of topiramate
- Body Mass Index (BMI) < 18kg/m2
- History of failure to respond to a previous adequate trial of either of the candidate medications for cocaine dependence
- Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention
- Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties,etc.) to participate in substance abuse treatment program
- Individuals with a current history (within the past 6 months) of amphetamine abuse or dependence including amphetamines such as methamphetamine and MDMA.

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 | |
STARS | |
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 |
Documents provided by Frances R Levin, New York State Psychiatric Institute:
Responsible Party: | Frances R Levin, Director of Substance Use Disorder, New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT01811940 |
Other Study ID Numbers: |
#6698 1U01DA033310-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | March 15, 2013 Key Record Dates |
Results First Posted: | October 12, 2018 |
Last Update Posted: | April 24, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
cocaine dependence adderall topiramate |
Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Topiramate |
Adderall Anticonvulsants Hypoglycemic Agents Physiological Effects of Drugs Central Nervous System Stimulants |