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

NCT00514202 | Terminated Phase 2 DMC

• 2 other identifiers: HSC-MS-07-0024P50DA009262
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cocaine; ADHD; attention; hyperactivity; drug; dependence

Outcome Measures

Primary Outcomes (2)

• Substance use

  Duration of study

• ADHD symptoms

  Duration of study

Secondary Outcomes (2)

• Treatment retention

  Duration of study

• Cocaine craving

  Duration of study

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo plus cognitive behavioral therapy

Drug: Placebo

2

EXPERIMENTAL

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

Drug: Dextroamphetamine SR

Interventions

Placebo DRUG

matched placebo

1

Dextroamphetamine SR DRUG

60 mg/day

Also known as: Dexedrine Spansules

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Cocaine-Related Disorders; Substance-Related Disorders; Spasm

Interventions

Amphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Chemically-Induced Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• David V Herin, Ph.D

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 9, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (1)