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

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: NCT00514202
Recruitment Status : Terminated (Investigator left UTHSC-Houston)
First Posted : August 9, 2007
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston

Brief Summary:
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 or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Cocaine-Related Disorders Substance-Related Disorders Drug: Placebo Drug: Dextroamphetamine SR Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD
Study Start Date : August 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Substance use [ Time Frame: Duration of study ]
  2. ADHD symptoms [ Time Frame: Duration of study ]

Secondary Outcome Measures :
  1. Treatment retention [ Time Frame: Duration of study ]
  2. Cocaine craving [ Time Frame: Duration of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00514202


Locations
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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
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Principal Investigator: David V Herin, Ph.D The University of Texas Health Science Center, Houston
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Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00514202    
Other Study ID Numbers: HSC-MS-07-0024
P50DA009262 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by The University of Texas Health Science Center, Houston:
cocaine
ADHD
attention
hyperactivity
drug
dependence
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Cocaine-Related Disorders
Substance-Related Disorders
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Chemically-Induced Disorders
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents