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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD

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

Intervention / Treatment
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* Drug: Placebo
* Drug: Dextroamphetamine SR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo plus cognitive behavioral therapy | Drug: Placebo<br>* matched placebo<br>|
| Experimental: 2<br>Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy | Drug: Dextroamphetamine SR<br>* 60 mg/day<br>* Other names: Dexedrine Spansules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use |  | Duration of study | 
| ADHD symptoms |  | Duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment retention |  | Duration of study | 
| Cocaine craving |  | Duration of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine, ADHD, attention, hyperactivity, drug, dependence