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Free Treatment for Cocaine Dependence: A Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) and Topiramate for the Treatment of Cocaine Dependence (TACT)
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), October 2009
First Received: January 10, 2007   Last Updated: October 15, 2009   History of Changes
Sponsor: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00421603
  Purpose

The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence. Since both of these medications have independently shown promise in helping with cocaine abuse we are proposing that together they may be even more successful in the treatment of cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients. This study includes free treatment for cocaine dependence that includes medication.


Condition Intervention Phase
Cocaine Dependence
Drug: Adderall-XR and Topiramate
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) and Topiramate for the Treatment of Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Cocaine Abstinence as measured by urine toxicology [ Time Frame: 3x/week ] [ Designated as safety issue: No ]
  • Pattern of cocaine use as measured by the TimeLine Followback [ Time Frame: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cocaine Craving as measured by the cocaine craving scale [ Time Frame: weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2007
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Adderall-XR and Topiramate
Drug: Adderall-XR and Topiramate
Adderall-XR 60mg/day and Topiramate 300mg/day
2: Placebo Comparator
Placebo
Drug: Placebo
Placebo

Detailed Description:

Specific Aim 1: To determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients.

Primary Hypothesis: The proportion of participants achieving sustained cocaine abstinence (via urine toxicology) for three consecutive weeks during the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.

Hypothesis 2: The proportion of urine samples negative for cocaine metabolites will be greater in the combined pharmacotherapies group compared to the placebo group.

Hypothesis 3: The pattern of cocaine use (amount of cocaine used per day in dollars and the number of using days per week), as measured by the time-line follow-back method, will show a greater reduction in use for the combined pharmacotherapies group compared to the placebo group.

Specific Aim 2: To determine the effect of ER-MAS and topiramate on cocaine craving among cocaine-dependent patients.

Hypothesis 4: Cocaine craving symptoms will be reduced to a greater degree in the combined pharmacotherapies group compared to the placebo group.

Specific Aim 3: To explore a set of related secondary outcomes (treatment retention, global functioning, HIV risk behavior) as well as moderators and mediators potentially reflective of mechanism of action.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence (DSM-IV-TR).
  2. Used cocaine at least four days in the past month, with at least weekly cocaine use.
  3. Must have a Body Mass Index (BMI) > 18 kg/m2
  4. Alcohol Breathalyzer (BraC) at consent of < 0.04%
  5. Individuals must be capable of giving informed consent and capable of complying with study procedures.
  6. Women of child bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.

Exclusion Criteria:

  1. Meets DSM-IV-TR criteria for bipolar disorder, Schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
  2. 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 or would be disrupted by study medication or are likely to require pharmacotherapy during the study period.
  3. Individuals with current major depressive disorder.
  4. Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention.
  5. Individuals with current psycho stimulant abuse or dependence.
  6. Individuals with current suicidal risk.
  7. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms.
  8. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP > 150, 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.
  9. Individuals with a history of seizures
  10. History of allergic reaction to candidate medication (amphetamine and/or ER-MAS or topiramate).
  11. Women who are pregnant or nursing.
  12. Use of carbonic anhydrase inhibitors*
  13. History of glaucoma, kidney stones*
  14. History of failure to respond to a previous Adequate trial of either candidate medication for Cocaine dependence
  15. Currently being prescribed psychotropic medication by another physician (other than sleep medication)
  16. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421603

Contacts
Contact: daniel j brooks, M.A. (212) 740-3205 brooksd@pi.cpmc.columbia.edu

Locations
United States, New York
STARS Recruiting
New York, New York, United States, 10032
Contact: Daniel J Brooks, M.A.     212-740-3205     brooksd@pi.cpmc.columbia.edu    
Principal Investigator: Frances R Levin, M.D.            
Sponsors and Collaborators
Investigators
Principal Investigator: Frances R Levin, M.D. Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: Columbia University/NYSPI ( Frances R. Levin, M.D )
Study ID Numbers: R01 DA022217, R01 DA022217, DPMCDA
Study First Received: January 10, 2007
Last Updated: October 15, 2009
ClinicalTrials.gov Identifier: NCT00421603     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
Cocaine
Adderall
Topiramate
ADHD

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adderall
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics
Disorders of Environmental Origin
Neuroprotective Agents
Sensory System Agents
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Vasoconstrictor Agents
Topiramate
Cocaine
Cocaine-Related Disorders
Sympathomimetics
Central Nervous System Depressants
Central Nervous System Stimulants
Cardiovascular Agents
Protective Agents
Anesthetics, Local
Pharmacologic Actions
Anti-Obesity Agents
Autonomic Agents
Amphetamine
Dopamine Agents

ClinicalTrials.gov processed this record on November 20, 2009