NCT00218348

Brief Summary

Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release of the neurotransmitter dopamine in the brain. The purpose of this study is to further examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

4.2 years

First QC Date

September 16, 2005

Last Update Submit

December 16, 2017

Conditions

Cocaine-Related Disorders

Keywords

Cocaine AbuseDextro-Amphetamine Sulfate

Outcome Measures

Primary Outcomes (1)

  • Substance use and retention

Secondary Outcomes (1)

  • Effectiveness measures, including psycho-social variables, side effects, and self-reported measures

Interventions

Dextro-Amphetamine SulfateDRUG

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV diagnosis of cocaine dependence, as determined by the Structured Clinical Interview for DSM-IV
  • Agreement to use an adequate method of contraception for the duration of the study
  • Electrocardiogram confirmation by a cardiologist
  • Cocaine-positive urine test prior to study entry

You may not qualify if:

  • High blood pressure
  • Significant heart disease
  • Clinically significant cardiovascular abnormality
  • Angina
  • Kidney, liver, or gastrointestinal disorder
  • Current Axis I disorder not related to drug use
  • Current dependence on any drug other than nicotine
  • Attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD)
  • On probation or parole for reasons other than those related to drug abuse charges
  • Pregnant or breastfeeding
  • Sought treatment for drug dependence within 3 months prior to study entry
  • Currently taking prescribed medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Joy M Schmitz, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Psy, Behavioral Science

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

September 1, 2003

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations

US(1)