NCT00439049

Brief Summary

The overarching goal of this project is to have a consolidated consent and evaluation procedure that will lead potential subjects to the most appropriate clinical trial or human laboratory study (and its consent process) for their presenting concerns or interests. A second purpose is to have a consolidated intake data base on which secondary analyses can be conducted.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
19.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

20.7 years

First QC Date

February 21, 2007

Last Update Submit

December 19, 2023

Conditions

Cocaine AbuseCocaine DependenceOpiate DependenceAlcohol DependenceSubstance Abuse

Keywords

Substance AbuseTreatmentEligibility

Outcome Measures

Primary Outcomes (1)

  • Urine Toxicology

    6 weeks to 24 weeks

Secondary Outcomes (1)

  • Demographics

    6 weeks to 24 weeks

Study Arms (1)

A

Cocaine Dependent Subjects

Drug: modafinilDrug: d-amphetamineDrug: L-DopaDrug: Naltrexone

Interventions

modafinilDRUG

400 mg daily

Also known as: Provigil
A
d-amphetamineDRUG

60mg daily

Also known as: Dexedrine
A
L-DopaDRUG

800/200mg daily

Also known as: Sinemet
A
NaltrexoneDRUG

50mg daily

Also known as: Revia
A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Cocaine Dependent Subjects

You may qualify if:

  • Willing and able to participate in 3- to 6-month treatment program.
  • At least 18 years of age.
  • Seeking treatment for substances of abuse including (cocaine, opiates, and alcohol).
  • Generally physically healthy.

You may not qualify if:

  • Pregnant or breastfeeding.
  • Mandated by the courts/parole officers to attend treatment.
  • Not seeking treatment for substances of abuse.
  • Plans to move from the Houston area within the 3- to 6-month treatment period.
  • Seeking treatment for a substance for which the Treatment Research Clinic (TRC) has no current trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute

Houston, Texas, 77054, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells

MeSH Terms

Conditions

Cocaine-Related DisordersOpioid-Related DisordersAlcoholismSubstance-Related Disorders

Interventions

ModafinilDextroamphetamineLevodopacarbidopa, levodopa drug combinationNaltrexone

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related DisordersAlcohol-Related Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesDihydroxyphenylalanineCatecholaminesCatecholsPhenolsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsTyrosineNaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Joy M. Schmitz, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

  • Frederick G Moeller, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

  • Angela L Stotts, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Vincent, BS

CONTACT

713-486-2803Jessica.N.Vincent@uth.tmc.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor - Psy, Behavioral Science

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 22, 2007

Study Start

October 1, 2005

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations

US(1)