Pilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-deficit Hyperactivity Disorder (ADHD)

This study has been terminated.

( Investigator left UTHSC-Houston )

First Received on August 7, 2007. Last Updated on February 21, 2012 History of Changes

Sponsor:	The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00514202

Purpose

Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this medication may decrease drug use in individuals dependent on cocaine. Thus, the present pilot study will determine the ability of dextroamphetamine to treat individuals with both cocaine dependence and ADHD.

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity Cocaine-Related Disorders Substance-Related Disorders	Drug: Placebo Drug: Dextroamphetamine SR	Phase 2

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:	Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Dextroamphetamine sulfate Dextroamphetamine Cocaine hydrochloride

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Substance use [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
ADHD symptoms [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Treatment retention [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Cocaine craving [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment:	5
Study Start Date:	August 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo plus cognitive behavioral therapy	Drug: Placebo matched placebo
Experimental: 2 Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy	Drug: Dextroamphetamine SR 60 mg/day Other Name: Dexedrine Spansules

Detailed Description:

This double-blind, placebo-controlled pilot study will determine the ability of dextroamphetamine to treat comorbid cocaine dependence and ADHD. Participants will be randomly assigned on receive placebo or Dextroamphetamine SR (60 mg/day) during a 12-week study period. All participants will receive weekly cognitive behavioral therapy.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provide informed consent
Generally good health except for problems related to drug use
Meet DSM criteria for cocaine dependence and ADHD
Have stable living situation

Exclusion Criteria:

DSM diagnosis for current psychotic, anxiety disorders as well as current substance dependence (with the exception of marijuana and nicotine)
Current use of prescription medications
Females who are currently pregnant or nursing
History of significant acute or chronic physical illness
History of or current liver disease
Existing cardiovascular disease
Plans to leave metropolitan area within 3 months
Probation or parole with constraints that preclude full study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514202

Locations

United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:

David V Herin, Ph.D

The University of Texas Health Science Center, Houston

More Information

No publications provided

Responsible Party:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00514202 History of Changes
Other Study ID Numbers:	HSC-MS-07-0024, P50 DA 009262
Study First Received:	August 7, 2007
Last Updated:	February 21, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

cocaine
ADHD
attention

hyperactivity
drug
dependence

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Cocaine-Related Disorders
Substance-Related Disorders
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cocaine
Dextroamphetamine
Vasoconstrictor Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on May 22, 2012