A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence - Full Text View

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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:

Drug Information available for: Amphetamine Topiramate

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:

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 ]
Cocaine use was assessed by using urine toxicology confirmed self-report. Self-reported cocaine use data was collected for each day of the study period. Urine samples were collected three times per week. A week was considered abstinence if no cocaine use was self reported during that week and if all urine samples collected that week were negative for cocaine. If a patient achieved three continuous weeks of abstinence based on this criteria they were considered cocaine abstinent in terms of this outcome measure.
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 ]


Enrollment:	81
Study Start Date:	February 2007
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Adderall-XR and Topiramate Adderall-XR (60 mg/day) and Topiramate (300mg/day)	Drug: Adderall-XR and Topiramate Adderall-XR 60mg/day and Topiramate 300mg/day
Placebo Comparator: Placebo 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 (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 current cocaine dependence (DSM-IV-TR).
Used cocaine at least four days in the past month, with at least weekly cocaine use.
Must have a Body Mass Index (BMI) > 18 kg/m2
Alcohol Breathalyzer (BraC) at consent of < 0.04%
Individuals must be capable of giving informed consent and capable of complying with study procedures.
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:

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 or would be disrupted by study medication or are likely to require pharmacotherapy during the study period.
Individuals with current major depressive disorder.
Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention.
Individuals with current psycho stimulant abuse or dependence.
Individuals with current suicidal risk.
Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms.
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.
Individuals with a history of seizures
History of allergic reaction to candidate medication (amphetamine and/or ER-MAS or topiramate).
Women who are pregnant or nursing.
Use of carbonic anhydrase inhibitors*
History of glaucoma, kidney stones*
History of failure to respond to a previous Adequate trial of either candidate medication for Cocaine dependence
Currently being prescribed psychotropic medication by another physician (other than sleep medication)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421603

Locations


United States, New York
STARS
New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Frances R Levin, M.D.	Columbia University

More Information

Additional Information:

Substance Treatment and Research Service of Columbia University This link exits the ClinicalTrials.gov site


Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00421603 History of Changes
Other Study ID Numbers:	#5368 R01DA022217 ( US NIH Grant/Contract Award Number )
Study First Received:	January 10, 2007
Results First Received:	December 13, 2012
Last Updated:	April 6, 2016

Keywords provided by New York State Psychiatric Institute:


Cocaine Adderall Topiramate ADHD

Additional relevant MeSH terms:


Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Cocaine Amphetamine Topiramate 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 Neuroprotective Agents Protective Agents Anti-Obesity Agents Central Nervous System Stimulants Sympathomimetics Autonomic Agents Adrenergic Agents Adrenergic Uptake Inhibitors

ClinicalTrials.gov processed this record on May 24, 2017

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