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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Terminated

CT.gov ID

NCT00514202

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity Cocaine-Related Disorders Substance-Related Disorders	Drug: Placebo Drug: Dextroamphetamine SR	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Dexedrine Spansules

Arm

Intervention/Treatment

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 Names:

Dexedrine Spansules

Outcome Measures

Primary Outcome Measures

Substance use [Duration of study]
ADHD symptoms [Duration of study]

Secondary Outcome Measures

Treatment retention [Duration of study]
Cocaine craving [Duration of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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