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

Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00514202
Enrollment
5
Registered
2007-08-09
Start date
2007-08-31
Completion date
2008-10-31
Last updated
2012-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cocaine, ADHD, attention, hyperactivity, drug, dependence

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.

Interventions

DRUGPlacebo

matched placebo

DRUGDextroamphetamine SR

60 mg/day

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Substance useDuration of study
ADHD symptomsDuration of study

Secondary

MeasureTime frame
Treatment retentionDuration of study
Cocaine cravingDuration of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026