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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Terminated
Phase 2

Conditions

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

Treatments

Drug: Placebo
Drug: Dextroamphetamine SR

Study type

Interventional

Funder types

Other

Identifiers

NCT00514202
HSC-MS-07-0024
P50DA009262 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

5 participants in 2 patient groups, including a placebo group

1
Placebo Comparator group
Description:
Placebo plus cognitive behavioral therapy
Treatment:
Drug: Placebo
2
Experimental group
Description:
Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy
Treatment:
Drug: Dextroamphetamine SR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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