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

Substance-Related Disorders Clinical Trial

Official title:

Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00514202
• Other study ID #: HSC-MS-07-0024
• Secondary ID: P50DA009262
• Status: Terminated
• Phase: Phase 2
• First received: August 7, 2007
• Last updated: February 21, 2012
• Start date: August 2007
• Est. completion date: October 2008

Study information

• Verified date: February 2012
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Cocaine-Related Disorders
• Disease
• Hyperkinesis
• Substance-Related Disorders

Intervention

Drug:
• Placebo
matched placebo
• Dextroamphetamine SR
60 mg/day

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance use		Duration of study	No
Primary	ADHD symptoms		Duration of study	No
Secondary	Treatment retention		Duration of study	No
Secondary	Cocaine craving		Duration of study	No

External Links

•   For more information, visit our web site