Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) and Cocaine Dependence - Full Text View

Sponsor:	New York State Psychiatric Institute
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):	Frances R Levin, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00553319

Purpose

The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine dependence. Since this medication has independently shown promise in helping with ADHD and cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.

Condition	Intervention	Phase
Adult Attention Deficit Hyperactivity Disorder Cocaine Dependence	Drug: Placebo Drug: Adderall-XR	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) and Cocaine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Dietary Sodium Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Cocaine hydrochloride Amphetamine sulfate Amphetamine Methamphetamine Sodium chloride

U.S. FDA Resources

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

Primary Outcome Measures:

cocaine urine toxicology results [ Time Frame: 3x/week for 14 weeks of trial or for length of participation ] [ Designated as safety issue: No ]
ADHD symptoms based on ADHD Rating Scale [ Time Frame: measured once per week for 14 weeks or length of study participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ADHD symptoms based on CGI [ Time Frame: measured weekly during 14 weeks or length of study participation ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	December 2007
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: Placebo Placebo group
Experimental: 2 Adderall-XR 60 mg	Drug: Adderall-XR Adderall-XR 60mg/day Other Name: Extended-Release Mixed Amphetamine Salts (Adderall-XR)
Experimental: 3 Adderall-XR 80 mg	Drug: Adderall-XR Adderall-XR 80mg/day Other Name: Extended-Release Mixed Amphetamine Salts (Adderall-XR)

Detailed Description:

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

Primary Hypothesis: Benzoylecognine positive urine screens will decrease with greatest to least reductions from 80mg>60mg>PBO.

Hypothesis 2: ADHD-Rating Scale will decrease with greatest to least reductions from 80mg>60mg>PBO.

Specific Aim 2: To determine the effect of ER-MAS on improving general functioning and impulsivity among comorbid ADHD and cocaine-dependent patients.

Hypothesis 4: There will be greater improved CGI scores in participants receiving d-AMPH compared to PBO.

Hypothesis 5: ER-MAS will decrease impulsivity as measured by several self-report (Barratts Impulsivity Scale) and behavioral measures (Card Sort, IMT, DMT, BART) compared to PBO.

This 14-week, three arm (two medication doses versus PBO), prospective, parallel groups, randomized PBO-controlled trial with a lead-in as well as medication run-up and run down weeks, will provide clear data on efficacy and safety for definitive Phase III trials, which if successful will lead to improved treatment for A-ADHD/S-SUD.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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 and adult ADHD (DSM-IV-TR).
Used cocaine at least eleven days in the past month
Must have a Body Mass Index (BMI) > 18 kg/m2
Alcohol Breathalyzer (BraC) at consent of < 0.04%
Must have a positive benzoylecognine urine screen during evaluation
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 other SUD (nicotine excepted), 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) which require medical intervention.
Individuals with current suicidal risk.
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.
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 a history of seizures
History of allergic reaction to candidate medication (amphetamine and/or ER-MAS).
Women who are pregnant or nursing.
History of failure to respond to a previous adequate trial of the 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553319

Contacts

Contact: Amy Mahony, MA	212-740-7351	mahonya@pi.cpmc.columbia.edu
Contact: Daniel Brooks, MA	212-740-3205	brooksd@pi.cpmc.columbia.edu

Locations

United States, Minnesota
Ambulatory Research Center/Fairview University Psychiatry Dept	Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: David Babb 612-627-4824 babbx001@umn.edu
Contact: Carla Amundson, M.A. CMAMUN01@smumn.edu
Principal Investigator: John Grabowski, PhD
United States, New York
STARS	Recruiting
New York, New York, United States, 10032
Contact: Amy Mahony, MA 212-740-7351 mahonya@pi.cpmc.columbia.edu
Contact: Daniel Brooks, MA 212-740-3205 brooksd@pi.cpmc.columbia.edu
Principal Investigator: Frances R Levin, MD

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:	Frances R Levin, MD	Columbia University
Principal Investigator:	John Grabowski	University of Minnesota - Clinical and Translational Science Institute

More Information

Additional Information:

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

No publications provided

Responsible Party:	Frances R Levin, Kennedy-Leavy Professor of Clinical Psychiatry, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00553319 History of Changes
Other Study ID Numbers:	R01 DA 23652-01, R01DA023652-01, R01 DA023652-01, DPMCDA
Study First Received:	November 2, 2007
Last Updated:	October 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:

ADHD
Cocaine
Treatment

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Cocaine-Related Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Substance-Related Disorders
Amphetamine
Methamphetamine
Adderall
Cocaine

Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012