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COMPLETED Phase 2

Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

NCT00238914 · View on ClinicalTrials.gov ↗

Study Summary

The overall goal of this research project is to test a newly developed behavioral therapy to enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES: 1. Outpatient treatment with Behavioral Naltrexone Therapy will yield a lower rate of relapse to illicit opiates compared to naltrexone plus Compliance Enhancement (CE) Therapy. 2. Lifetime history of depression will predict dysphoria and non-compliance with naltrexone.

Conditions Studied

Interventions

  • DRUG Naltrexone
  • BEHAVIORAL Behavioral Naltrexone Therapy (BNT)
  • BEHAVIORAL Compliance Enhancement (CE)

Study Locations (1)

New York

  • New York State Psychiatric Institute — New York

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 1999-08
Est. Completion 2002-07
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00238914

The ClinicalTrials.gov registry entry for NCT00238914 describes a study currently listed as completed. It is categorized as Phase 2, 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 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 117 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 Heroin Dependence appearing as the primary indexed condition, and to 3 interventions — of which Naltrexone 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: NCT00238914 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. 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 NCT00238914 about?

NCT00238914 is a clinical study titled "Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1". The overall goal of this research project is to test a newly developed behavioral therapy to enhance the efficacy of naltrexone maintenance and make it a viable alternative to methadone maintenance or detoxification methods for treatment of opiate dependence. HYPOTHESES: 1. Outpatient treatment wit...

What is the current status of trial NCT00238914?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 1999-08. Estimated completion is 2002-07.

What conditions does trial NCT00238914 study?

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

What interventions are being tested in trial NCT00238914?

The interventions under investigation include: Naltrexone (DRUG), Behavioral Naltrexone Therapy (BNT) (BEHAVIORAL), Compliance Enhancement (CE) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00238914?

This trial is sponsored by New York State Psychiatric Institute, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00238914 being conducted?

This trial has 1 study location across New York. 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