Cocaine AbuseNCT00439049
Substance Abuse Pre-Treatment Screening Study
An observational study of Cocaine Abuse and Cocaine Dependence, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine Abuse, Cocaine Dependence, Opiate Dependence
- What is being tested?
- modafinil, d-amphetamine and L-Dopa
- How many people
- 7,500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Cocaine Dependent Subjects
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute
Houston, Texas, 77054
Rolanda Johnson, MA, 713-486-2823, Rolanda.Johnson@uth.tmc.edu
Joy M Schmitz, Ph.D.
About this study
Official title: General Evaluation of Eligibility for Substance Abuse/Dependence Research
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.
Read the detailed description
Approximately 1500 candidates per year will respond to advertisements and will complete preliminary telephone screening without identifiers. Appropriate candidates will be given appointment times and on arrival will undergo the consent process for evaluation. A complete medical, social, psychiatric, and drug use history will be obtained. Subjects fulfilling general health inclusion requirements will then be offered an appropriate study for which the specific consent will be obtained. The evaluation period will be no more than one day with all results evaluated within the two following days. Acceptable candidates will then be invited to complete the study specific consent.
- Being tested
- modafinil, d-amphetamine, L-Dopa, Naltrexone
- Keywords
- Substance Abuse, Treatment, Eligibility
- Medical subject headings
- Cocaine-Related Disorders, Opioid-Related Disorders, Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinilDrug
Also called Provigil
400 mg daily
d-amphetamineDrug
Also called Dexedrine
60mg daily
L-DopaDrug
Also called Sinemet
800/200mg daily
NaltrexoneDrug
Also called Revia
50mg daily
| Study group | Role | What they receive |
|---|---|---|
| A | Cocaine Dependent Subjects Receives: Drug: modafinil; Drug: d-amphetamine; Drug: L-Dopa; Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Toxicology
Measured: 6 weeks to 24 weeks
Secondary outcomes (1)
Demographics
Measured: 6 weeks to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startOct 2005
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Joy Schmitz, The University of Texas Health Science Center, Houston
- Investigators
- Joy M. Schmitz, PhD, Principal investigator, The University of Texas Health Science Center, HoustonFrederick G Moeller, MD, Principal investigator, The University of Texas Health Science Center, HoustonAngela L Stotts, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439049
- Sponsor's protocol ID
- NIDA-09262-13
- Other IDs
- P50DA009262, DPMCDA
- Status last verified
- Dec 2023
- First submitted
- 21 Feb 2007
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Evaluation of Eligibility for Substance Abuse/Dependence Research
- ClinicalTrials.gov ID
- NCT00439049
- Acronym / sponsor ID
- NIDA-09262-13
- Keywords
- Substance Abuse, Treatment, Eligibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2005
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 1500 candidates per year will respond to advertisements and will complete preliminary telephone screening without identifiers. Appropriate candidates will be given appointment times and on arrival will undergo the consent process for evaluation. A complete medical, social, psychiatric, and drug use history will be obtained. Subjects fulfilling general health inclusion requirements will then be offered an appropriate study for which the specific consent will be obtained. The evaluation period will be no more than one day with all results evaluated within the two following days. Acceptable candidates will then be invited to complete the study specific consent.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: modafinil, Drug: d-amphetamine, Drug: L-Dopa, Drug: NaltrexoneCocaine Dependent Subjects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Cocaine Dependent Subjects
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modafinilAlso: Provigil400 mg daily | Drug | A |
| d-amphetamineAlso: Dexedrine60mg daily | Drug | A |
| L-DopaAlso: Sinemet800/200mg daily | Drug | A |
| NaltrexoneAlso: Revia50mg daily | Drug | A |
Primary outcome
Urine Toxicology
Time frame: 6 weeks to 24 weeks
1 secondary outcome
Demographics
Time frame: 6 weeks to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy M. Schmitz, PhD principal investigator
The University of Texas Health Science Center, Houston
Frederick G Moeller, MD principal investigator
The University of Texas Health Science Center, Houston
Angela L Stotts, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Abuse and Cocaine Dependence, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Vincent, BS (713-486-2803, Jessica.N.Vincent@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Toxicology (time frame: 6 weeks to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.