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Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence (TACT2)

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.
 
ClinicalTrials.gov Identifier: NCT01811940
Recruitment Status : Completed
First Posted : March 15, 2013
Results First Posted : October 12, 2018
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

Brief Summary:
The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participants achieving sustained cocaine abstinence for three consecutive weeks at the end of the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Adderall-ER Drug: Topiramate Other: Placebo Phase 2 Phase 3

Detailed Description:
The investigators hypothesize that the combination of an agent that increased baseline dopamine signaling (amphetamine) with one that reduced cocaine-induced dopamine release (topiramate) will improve dopamine regulation and be associated with improved cocaine use outcomes. 99 subjects at each of the two sites whom meet criteria for cocaine dependence, and all other study inclusion and exclusion criteria will be assigned to the 14-week double-blind, placebo-controlled treatment trial. Subjects will be randomized to receive either placebo or MAS-ER and topiramate. This proposal will test the hypothesis that MAS-ER and topiramate will promote cocaine abstinence. Participants who are randomized to the combination medication arm will have their dose titrated to 60 mg MAS-ER daily (over 2 weeks) and 200 mg topiramate a day (over 6 weeks) and maintained on this dose through week 13 of the trial. During week 14, participants will be tapered off both medications. All participants will receive a supportive behavioral treatment that emphasizes study procedure adherence. Starting in week one, all patients will receive incentives for compliance with study procedures on an escalating reinforcement schedule similar to that developed previously and not contingent on urine results. The purpose of the lead-out is to blind patients to the exact point of medication discontinuation and to provide naturalistic data on the effects of medication discontinuation. Moreover, a 3 month follow-up will be conducted to determine what happens to cocaine use after treatment discontinuation.

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, New York
STARS
New York, New York, United States, 10032
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Frances Levin, M.D. Columbia University
Principal Investigator: Kyle Kampman, MD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Frances R Levin, New York State Psychiatric Institute:
Study Protocol  [PDF] December 5, 2017
Statistical Analysis Plan  [PDF] January 1, 2018


Additional Information:
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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
Keywords provided by Frances R Levin, New York State Psychiatric Institute:
cocaine dependence
adderall
topiramate
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Topiramate
Cocaine
Adderall
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Anticonvulsants
Hypoglycemic Agents
Central Nervous System Stimulants