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

NCT ID: NCT00514202

Last Updated: 2012-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-10-31

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Placebo plus cognitive behavioral therapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matched placebo

2

Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy

Group Type EXPERIMENTAL

Dextroamphetamine SR

Intervention Type DRUG

60 mg/day

Interventions

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Placebo

matched placebo

Intervention Type DRUG

Dextroamphetamine SR

60 mg/day

Intervention Type DRUG

Other Intervention Names

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Dexedrine Spansules

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David V Herin, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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University of Texas Health Science Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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P50DA009262

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-07-0024

Identifier Type: -

Identifier Source: org_study_id

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