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NCT00444418 · ClinicalTrials.gov registry record · Phase 3

Medication and Counseling for Controlled Drinking (Project SMART)

A Phase 3 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Completed
Registry status
Phase 3
Development phase
200
Enrollment target

NCT00444418: Completed Phase 3 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

NCT00444418 is a Phase 3 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00444418, a Phase 3 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

COMPLETED
Registry status
Phase 3
Development phase
200 participants
Enrollment target

Study Summary

The purpose of this study is to study the effectiveness of medication and specialized psychotherapy in helping gay and bisexual men who do not want to quit drinking learn how to reduce their drinking to healthier levels. More information on the study is available at www.projectsmartnyc.org.

Interventions

  • DRUG Naltrexone
  • BEHAVIORAL Modified Behavioral Self-Control Psychotherapy
  • BEHAVIORAL Brief Behavioral Compliance Enhancement Therapy

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2006-04
Est. Completion 2010-06
Phase Phase 3

What the finished NCT00444418 record still lists

NCT00444418 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 3 interventions - of which Naltrexone is the first listed.

NCT00444418 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00444418 about?

NCT00444418 is a clinical study titled "Medication and Counseling for Controlled Drinking (Project SMART)". The purpose of this study is to study the effectiveness of medication and specialized psychotherapy in helping gay and bisexual men who do not want to quit drinking learn how to reduce their drinking to healthier levels. More information on the study is available at www.projectsmartnyc.org.

What is the current status of trial NCT00444418?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2006-04. Estimated completion is 2010-06.

What interventions are being tested in trial NCT00444418?

The interventions under investigation include: Naltrexone (DRUG), Modified Behavioral Self-Control Psychotherapy (BEHAVIORAL), Brief Behavioral Compliance Enhancement Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT00444418?

This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00444418's enrollment target sits among peer trials

200 1353rd of 2000 higher than 613 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00444418, the US trial registry maintained by the National Library of Medicine. NCT00444418 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.