NCT00000304

Brief Summary

The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 1997

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

August 1, 1997

Completed
2.1 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
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

September 20, 1999

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (1)

  • verifiable cocaine abstinence

    16 weeks of study

Study Arms (3)

1

EXPERIMENTAL

15/30 mg d-amphetamine

Drug: Dextroamphetamine

2

EXPERIMENTAL

30/60 mg d-amphetamine

Drug: D-Amphetamine

3

EXPERIMENTAL

placebo

Drug: Placebo

Interventions

DextroamphetamineDRUG

15 mg for first 8 weeks and 30 mg for 2nd 8 weeks

1
D-AmphetamineDRUG

30 mg for the first 8 weeks and 60 for the second 8 weeks (16 weeks total)

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 DisordersSubstance-Related Disorders

Interventions

Dextroamphetamine

Condition Hierarchy (Ancestors)

Chemically-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

August 1, 1997

Primary Completion

August 1, 2001

Study Completion

August 1, 2001

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(1)