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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)
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00514202
First received: August 7, 2007
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  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:

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 21, 2013