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

Tracking Information

First Received Date ^ICMJE

August 7, 2007

Last Updated Date

November 6, 2008

Start Date ^ICMJE

August 2007

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Substance Use [ Time Frame: Duration of study ]
ADHD Symptoms [ Time Frame: Duration of study ]

Change History

Complete list of historical versions of study NCT00514202 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Treatment Retention [ Time Frame: Duration of study ]
Cocaine Craving [ Time Frame: Duration of study ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Attention Deficit Disorder With Hyperactivity
Cocaine-Related Disorders
Substance-Related Disorders

Intervention ^ICMJE

Drug: Placebo
Drug: Dextroamphetamine SR

Study Arms / Comparison Groups

Placebo Comparator: Placebo plus cognitive behavioral therapy
Experimental: Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

October 2008

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00514202

Responsible Party

David V. Herin, Ph.D/Principal Investigator, University of Texas Health Science Center - Houston

Study ID Numbers ^ICMJE

HSC-MS-07-0024, P50 DA 009262

Study Sponsor ^ICMJE

The University of Texas Health Science Center, Houston

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David V Herin, Ph.D

The University of Texas Health Science Center, Houston

Information Provided By

The University of Texas Health Science Center, Houston

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP