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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: Completed Phase 2 study, sponsored by Boston Medical Center.
NCT00248612 is a Phase 2 study that has completed, run by Boston Medical Center. The registered enrollment target is 162 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Global improvement of alcohol dependence: Rate the total improvement in the participant's alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed? (1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse)
Interventions
- BEHAVIORAL CBT
- DRUG Venlafaxine
- OTHER Progressive muscle relaxation therapy (PMR)
- OTHER Placebo medication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2003-09 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
What the finished NCT00248612 record still lists
NCT00248612 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 4 interventions - of which CBT is the first listed.
NCT00248612 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00248612's enrollment target sits among peer trials
162 418th of 2000 higher than 1,579 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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