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COMPLETED Phase 4

Post-Treatment Effects of Naltrexone

NCT00006449 · View on ClinicalTrials.gov ↗

Study Summary

The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level of cravings for alcohol.

Conditions Studied

Interventions

  • DRUG naltrexone (Revia)
  • BEHAVIORAL broad spectrum treatment
  • BEHAVIORAL motivational enhancement therapy

Study Locations (1)

Indiana

  • Institute of Psychiatric Research, Indiana University School of Medicine — Indianapolis

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2000-09
Est. Completion 2006-07
Phase Phase 4

Sponsor

Indiana University

1,026 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00006449

The ClinicalTrials.gov registry entry for NCT00006449 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 1,026 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Alcoholism appearing as the primary indexed condition, and to 3 interventions — of which naltrexone (Revia) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00006449 reports 1 study location spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00006449 about?

NCT00006449 is a clinical study titled "Post-Treatment Effects of Naltrexone". The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level...

What is the current status of trial NCT00006449?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2000-09. Estimated completion is 2006-07.

What conditions does trial NCT00006449 study?

This clinical trial studies the following conditions: Alcoholism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00006449?

The interventions under investigation include: naltrexone (Revia) (DRUG), broad spectrum treatment (BEHAVIORAL), motivational enhancement therapy (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00006449?

This trial is sponsored by Indiana University, which has 1,026 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00006449 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial