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NCT00248612 · ClinicalTrials.gov registry record · Phase 2

Psychosocial and Medication Treatment for Anxiety in Alcoholism

A Phase 2 study, sponsored by Boston Medical Center.

Completed
Registry status
Phase 2
Development phase
162
Enrollment target

NCT00248612 is a Phase 2 study that has completed, run by Boston Medical Center. The registered enrollment target is 162 participants.

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The verdict

NCT00248612, a Phase 2 study, has completed, sponsored by Boston Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
162 participants
Enrollment target

Study Summary

The proposed project is written as a "typical clinical practice" test and is a fully-controlled trial of a combined anxiety-focused CBT and pharmacotherapy (venlafaxine; CBT-VEN) delivered for patients with comorbid alcohol-use and anxiety disorders. The CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication. One hundred and eighty participants will be recruited and, subsequent to a platform of outpatient treatment for alcoholism, will be randomly assigned to a 12-week treatment condition. All treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo. The treatments will conclude with a 2-week medication/placebo taper. Follow-up assessments will be conducted at post-treatment and at 3, 6, 9, and 12-months. The long-term objectives of this research are to develop a real-world combination of psychosocial and pharmacological treatments for patients with comorbid alcohol-use and anxiety disorders that compromise prognosis, and to evaluate the effectiveness of combined psychosocial and pharmacological treatments that target anxiety among patients with this comorbidity.

Interventions

  • BEHAVIORAL CBT
  • DRUG Venlafaxine
  • OTHER Progressive muscle relaxation therapy (PMR)
  • OTHER Placebo medication

Trial Details

FieldValue
Enrollment Target 162 participants
Start Date 2003-09
Est. Completion 2009-03
Phase Phase 2

Sponsor

Boston Medical Center

253 total trials

What the Registry Record Tells You About NCT00248612

The ClinicalTrials.gov registry entry for NCT00248612 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Medical Center, which has 253 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which CBT is the first listed.

NCT00248612 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00248612 about?

NCT00248612 is a clinical study titled "Psychosocial and Medication Treatment for Anxiety in Alcoholism". The proposed project is written as a "typical clinical practice" test and is a fully-controlled trial of a combined anxiety-focused CBT and pharmacotherapy (venlafaxine; CBT-VEN) delivered for patients with comorbid alcohol-use and anxiety disorders. The CBT and pharmacotherapy will be contrasted wi...

What is the current status of trial NCT00248612?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2003-09. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00248612?

The interventions under investigation include: CBT (BEHAVIORAL), Venlafaxine (DRUG), Progressive muscle relaxation therapy (PMR) (OTHER), Placebo medication (OTHER).

Who is sponsoring clinical trial NCT00248612?

This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.

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

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