Back to resultsPilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders, Substance-Related Disorders
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Dextroamphetamine SR
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring cocaine, ADHD, attention, hyperactivity, drug, dependence
Eligibility 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
Sites / Locations
- University of Texas Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Placebo plus cognitive behavioral therapy
Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy
Outcomes
Primary Outcome Measures
Substance use
ADHD symptoms
Secondary Outcome Measures
Treatment retention
Cocaine craving
Full Information
NCT ID
NCT00514202
First Posted
August 7, 2007
Last Updated
February 21, 2012
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT00514202
Brief Title
Pilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-deficit Hyperactivity Disorder (ADHD)
Official Title
Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Investigator left UTHSC-Houston
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders, Substance-Related Disorders
Keywords
cocaine, ADHD, attention, hyperactivity, drug, dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo plus cognitive behavioral therapy
Arm Title
2
Arm Type
Experimental
Arm Description
Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matched placebo
Intervention Type
Drug
Intervention Name(s)
Dextroamphetamine SR
Other Intervention Name(s)
Dexedrine Spansules
Intervention Description
60 mg/day
Primary Outcome Measure Information:
Title
Substance use
Time Frame
Duration of study
Title
ADHD symptoms
Time Frame
Duration of study
Secondary Outcome Measure Information:
Title
Treatment retention
Time Frame
Duration of study
Title
Cocaine craving
Time Frame
Duration of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David V Herin, Ph.D
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-deficit Hyperactivity Disorder (ADHD)
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