NCT00000308

Brief Summary

The purpose of this study is to examine dextroamphetamine-cocaine behavioral intervention in cocaine dependent patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 1995

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1995

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2000

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

Enrollment Period

5 years

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (1)

  • Verifiable cocaine abstinence

    16 weeks of study

Study Arms (3)

1

EXPERIMENTAL

15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks

Drug: Dextroamphetamine

2

EXPERIMENTAL

30 mg of d-amphetamine for first 8 weeks of study and 60 mg for the second 8 weeks

Drug: D-amphetamine

3

EXPERIMENTAL

placebo

Drug: placebo

Interventions

DextroamphetamineDRUG

15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks

1
D-amphetamineDRUG

15 mg of d-amphetamine for first 8 weeks of study and 30 mg for the second 8 weeks

2
placeboDRUG

placebo

3

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77225, 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

  • John Grabowski, Ph.D.

    University of Texas

    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
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

September 1, 1995

Primary Completion

September 1, 2000

Study Completion

September 1, 2000

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(1)