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

February 21, 2012 updated by: The University of Texas Health Science Center, Houston

Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1
Placebo plus cognitive behavioral therapy
Drug: Placebo
matched placebo
EXPERIMENTAL: 2
Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy
Drug: Dextroamphetamine SR
60 mg/day
Other Names:
  • Dexedrine Spansules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Substance use
Time Frame: Duration of study
Duration of study
ADHD symptoms
Time Frame: Duration of study
Duration of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment retention
Time Frame: Duration of study
Duration of study
Cocaine craving
Time Frame: Duration of study
Duration of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: David V Herin, Ph.D, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

August 7, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (ESTIMATE)

August 9, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Substance-Related Disorders

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe