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

Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity; Cocaine-Related Disorders; Substance-Related Disorders

Intervention: Placebo (Drug); Dextroamphetamine SR (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: The University of Texas Health Science Center, Houston

Official(s) and/or principal investigator(s):
David V Herin, Ph.D, Principal Investigator, Affiliation: The University of Texas Health Science Center, Houston

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.

Clinical Details

Official title: Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Substance use

ADHD symptoms

Secondary outcome:

Treatment retention

Cocaine craving

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

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

Starting date: August 2007
Last updated: February 21, 2012

Page last updated: August 20, 2015

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