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

Phase 2

Terminated

• Conditions: Attention Deficit Disorder With Hyperactivity; Cocaine-Related Disorders; Substance-Related Disorders
• Interventions: Drug: Placebo; Drug: Dextroamphetamine SR

• Registration Number: NCT00514202
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-08
• Study First Posted: 2007-08-09
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo plus cognitive behavioral therapy
2	Dextroamphetamine SR	Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy

Primary Outcome Measures

Name	Time	Method
Substance use	Duration of study
ADHD symptoms	Duration of study

Secondary Outcome Measures

Name	Time	Method
Treatment retention	Duration of study
Cocaine craving	Duration of study

Trial Locations

Locations (1)

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States